Editorial


Restoration of Extensive Outside Access for Organic Certification Likely

01/23/2021

With the restoration of Tom Vilsak to the position of Secretary of the USDA, there will be a reevaluation of outside access requirements for egg production under the USDA Certified Organic program.  It will be remembered that in 2017 on the last day of the Obama Administration, Secretary Vilsak approved the rule mandating minimum outside access. This would have effectively disqualified in-line barn and multi-level aviary units.  Then Secretary Dr. Sonny Perdue rescinded the rules allowing sun porches to substitute for outside access.


Hens with outside access to soil

With the inception of a new Administration it is obvious that animal rights groups including HSUS and representatives of organizations representing small-scale organic egg producers will agitate for restoration of the previous housing requirements.

 

It is therefore expected that if the outside access requirement is mandated, that a new category of eggs distinct from but parallel to organic regulations will emerge. Eggs will be derived from flocks housed in barns or in building fitted with aviaries, fed GMO feed and complying with most organic requirements with the exception of outside access.  It is anticipated that under the rules as proposed in 2016, certified organic eggs derived from hens allowed outside access and  the new category of GMO-free/humane-housed hens would be positioned below current organic prices.

 

Growth in organic egg production has stalled over many months based on price relative to alternatives including cage-free and even generic product. Imposing an excessive outside access requirement would disqualify a high proportion of current organic egg supply to the benefit of smaller-scale producers. This would satisfy the original intent of the extended outside access requirement.  Producers advocating outside access may be disappointed if their wish is granted as they will be supplying a smaller market with more intense competition, albeit at a higher price.


Organic egg complex with sun porches

 

E.U. Trends Likely to Influence U.S. Agriculture.

01/16/2021

According to USDA-FAS GAIN report E42021-0007 released on January 12th 2021, a number of trends affecting E.U. agricultural policy emerged from the Farm to Fork Conference held in mid-October 2020.  The objective of the meeting was to create an international alliance and to develop global standards on sustainability and welfare.  The Conference was strongly supported by Ursula von der Leyen, President of the European Commission and by the Agricultural and Health Commissioners of Germany and other prominent EU states.  Items considered by the Farm to Fork conference that have relevance to the U.S. include:-


E.U. nations before BREXIT

 


E.U. Commissioner Ursala von der Leyden
  • The European Green Deal

This initiative to be enacted in the proposed Climate Law will be legally binding for all 27 European Union member states. The proposal will establish carbon neutrality by 2050 and progress in reducing greenhouse gas emissions. The outgoing U.S. Administration has consistently denied the reality of climate change and has relaxed environmental regulations contrary to movements in the Europe and Asia.  This was exemplified by withdrawal from the Paris Accords and characterizing coal as “beautiful and clean”.  It is anticipated that the incoming Administration will reverse many of the policy decisions of the past four years and move towards commonality with the E.U. as a condition for trade.  On December 17th, all 27 E.U. Ministers of the Environment adopted the European Council position on the Climate Law incorporating a target of 55 percent reduction in greenhouse gas emissions by 2030, compared to the 1990 base.

  • Mandatory Nutrition Labeling

The E.U. will harmonize front-of-pack nutrition labeling by the end of 2022.  The intent is to provide consumers with information enabling health-conscious choices with adoption of the Nutri-Score labeling as introduced in France and since adopted by Belgium, Spain, the Netherlands and Germany.  Given that many U.S. producers of food products are subsidiaries of multinational corporations such as Nestle and Danone, it is anticipated that the front-of-pack nutrition labeling will eventually be adopted in the U.S.

  • Establishing Nutrient Profiles

The restrictions on salt, sugars and fat established by Regulation #1924 in 2006 will be fully implemented before the end of 2022. It is anticipated that there will be harmonization of nutritional specifications among industrialized nations of the northern hemisphere motivated by trade and health considerations.

  • Animal Welfare labeling

 A November 3rd 2020 meeting of the E.U. Platform on Animal Welfare announced a committee to produce a report by mid 2021 to evaluate consumer awareness and the economic impact of mandatory welfare standards. Julia Kloeckner, the German Federal Minister of Food and Agriculture stated, "a common E.U. label for animal welfare would increase credibility and transparency in our markets and would enable consumers to make more informed choices and would help reward producers who comply with standards”.

  • Country of Origin Labeling

The European ministers of agriculture considered Country of Origin Labeling (COOL) in mid-December 2020. Given a number of foodborne health incidents associated with certain E.U. producer nations, this provision that could be regarded as discriminatory and possibly in contravention of WTO Regulations indicates concern among member nations. 

  • Product Dating

The EU will propose revisions to existing rules relating to use by and best before dates.  An improvement of presentation format or wording will be developed possibly abandoning the best before descriptor.

  • Chemical-based Pesticides

The European Commission will take action to reduce the application and by extension, exposure of consumers to chemical pesticides.  A target of 50 percent reduction by 2030 is envisaged.

  • Feed Additives

The Commission will consider the adoption of sustainable and innovative feed additives by revising current legislation.  Additives will be promoted on the basis of reducing greenhouse gas emissions and contributing to sustainable farming.

  • Promoting Organic Farming

As part of the Biodiversity Strategy, the European commission set a goal of 25 percent of agricultural land for organic farming by 2030, up from the current eight percent.  Well-meaning legislatures will have to reconcile the need for food with the inherent inefficiency of organic farming as we know it.  A legislative proposal relating to the EU Green Deal and Farm to Fork strategy is expected by the end of the current year.

The EU has a long history of advancing welfare, sustainability and reducing the impact of agriculture and industry on climate change. The E.U. comprises close to 500 million in population (including the UK) and is the world's largest trading group with defined rules and procedures. Accordingly the U.S. cannot ignore trends in agriculture if we are to trade freely and enjoy political and cultural relations to our mutual benefit.


 

Highly pathogenic avian influenza in the E.U. During 2020

01/10/2021

A moderator for ProMed Mail described the sequence of HPAI outbreaks attributed to H5N8 during 2020. Clearly the infection was introduced and disseminated by migratory waterfowl. The implications for the U.S. are self-evident despite the fading recollections of 2015. The description of the sequence of two distinct outbreaks is reproduced below for the benefit of subscribers:-

"During 2020, 2 distinct epidemic seasons of highly pathogenic avian influenza (HPAI) were observed in the European Union. The 1st HPAI epidemic season started on 31 Dec 2019, with the 1st outbreak in poultry confirmed in Poland. A new HPAI virus of subtype H5N8 (2020) was involved in the outbreak. By March [2020], the disease was  confirmed in Poland, Czechia, Germany, Hungary, Slovakia, and Romania.

The H5N8 (2020) subtype of the HPAI virus was responsible for all of these outbreaks. The most affected Member State was Hungary, after the virus entered in the area with a high density of duck and geese holdings. Outbreaks of HPAI were also detected in Bulgaria between March and June 2020, but the virus involved was of subtype H5N8, which also circulated in Bulgaria in 2018-2019. The last outbreak in poultry related to the 1st epidemic season of HPAI was confirmed on 5 Jun 2020”.

 

"Only 3 wild birds were found infected with HPAI during the 1st half of 2020 (in Germany and Poland). The virus involved was the same as the one detected in the poultry farms”.

 

"The 2nd HPAI epidemic season started at the end of October 2020 when the 1st cases were reported in wild birds in the Netherlands. Again, the 1st HPAI virus detected was of H5N8 subtype, different from the one that circulated in the 1st half of the year [2020]. Since then and until the end of 2020, a high number of dead and sick wild birds, mostly of migratory species, were found to be infected with HPAI viruses of subtypes H5N8, H5N5, H5N1, and H5N3 being detected by several EU countries and the United Kingdom. The largest number of cases in wild birds were reported in the northern part of Germany,  in Denmark, and in the Netherlands. Between October and end of December 2020, the disease was also confirmed in poultry in Croatia, Denmark, France, Ireland, Germany, the Netherlands, Poland, Sweden, and the United Kingdom”

 

Lessons can be derived from the unfortunate experiences with HPAI in the E.U.

  • Since wild birds are carriers waterfowl hunting by personnel in the poultry industry should be prevented
  • Free-range and backyard flocks are the link between migratory birds and large commercial farms and complexes
  • Commercial waterfowl and turkeys appear to become infected in affected regions before chickens
  • Solid biosecurity is an effective preventive measure.
  • Constant surveillance of wild birds is necessary with appropriate molecular characterization.
  • Most governments impose “stamping out” programs to control outbreaks of HPAI. Most Governments in the E.U. effectively eradicate HPAI every year!
  • We need effective broad spectrum H5 and H7 vaccines to create immune commercial poultry populations so as to limit mass dissemination as was observed in the 2015 U.S. epornitic and the biphasic E.U. ongoing event.
  • Recognition of the OIE principle of regionalization is a tacit recognition of the extent, distribution and periodicity of HPAI.

 

Comments and contributions are solicited to establish an industry dialog.

 


 

Concern over SARS-COV-2 Variants

12/29/2020

With the increased frequency of sequencing isolates of SARS-CoV-2, the virus responsible for COVID-19 in many nations, it is apparent that mutations are occurring that enhance infectivity. Mutations may affect response to antibody therapy and effectiveness of a range of vaccines based on mRNA, adenovirus-vectors and nanoparticle subunit technology. 

 

The variant VOC (variant of concern) 202012/01 also termed variant B.1.1.7, and a similar variant in South African both carry mutation N501 that enhances infectivity.  The UK variant has acquired 17 mutations affecting both the spike protein and nucleoprotein.  The concurrent N501mutation increases the ability of the virus to bind to human ACE receptors.  The mutation in this variant was recognized in early September in the U.K. but since November has become the predominant virus in Southeast England accounting for 60 percent of infections. 

 

A variant with the 69-70 del mutation involves deletion of two amino acids allowing the virus to be refractory to an immune response.  This change is also observed in the variant mink virus first identified in Denmark.  Mutation P681H occurs at the cleavage site of the spike protein and may be associated with increased pathogenicity.  Insertion of basic amino acids at the cleavage site of the hemagglutinating surface protein of avian influenza viruses is associated with increased pathogenicity relating to the ability of the virus to enter host cells.  It has yet to be shown that the variants carrying P681H are in fact more pathogenic in humans.


Dr. Anthony S Fauci

Dr. William Haseltine

An observation of concern is that where sequencing studies are carried out on a routine basis, variants are documented with increasing frequency.  The U.K. variant is now present in France and Belgium despite border and travel restrictions imposed in late December that basically represented closing the stable door after the horse had bolted.  Simultaneous emergence of variants in the Republic of South Africa and Nigeria, apparently showing greater infectivity reflect the innate ability of single-stranded RNA viruses to undergo mutations many of which are beneficial to the pathogen through infecting a greater number of hosts.

 

Dr. William Haseltine, president of Access Health International, a think tank, formerly a Professor at Harvard Medical School and a renowned educator, author and philanthropist, correctly notes that COVID-19 in various forms may be with us for many years to come. This will be despite the adoption of vaccines directed against the spike protein of the virus.  He notes that the mRNA vaccines including the Pfizer and Moderna products that received emergency use authorization in December in addition to the adenovirus vector vaccines including the AstraZeneca-Oxford and the Sputnik-5 product from Russia are all directed against spike protein.  In contrast, China has developed vaccines based on inactivated whole virus that may in the long term be more effective in suppressing SARS-COV-2 by stimulating a broader antibody response.

 

In past weeks, studies of the sequences of SARS-COV-2 have disclosed a lack of information regarding the molecular composition of current viruses in circulation.  The number of sequence assays of isolates in the U.K. is infinitely higher than in the U.S. Accordingly we have yet to detect the altered viruses that in all probability are undergoing community spread. The proportion of 0.5 percent of isolates sequenced the U.S. compares unfavorably with the U.K. with a rate of five percent. Of isolates from patients Information on the virus strains present in sub-populations allows health authorities and epidemiologists to identify the emergence of variants and their mode of transmission.  The need for greater surveillance of isolates from patients using a structured program is advocated by Dr. Anthony S. Fauci, Director of the  NIAID -NIH. His promotion of sequencing isolates is justified by the December 29th recognition of the U.K. variant in a patient in Colorado with no history of travel, suggesting community transmission.

 

The expedient of requiring a negative PCR or antigen assay for intended visitors to the U.S. is at best a “feel-good” measure since an air traveler with a negative test conducted three days before entry to the U.S. may still permit introduction of a variant of SARS-COV-2.as has occurred in Canada. Without detailed and structured sequencing, we do not know whether variants carrying the N501 and P681H mutations are in fact present in the U.S. and are undergoing community spread. We do not have adequate information on how U.S. variants are emerging nor have we monitored possible changes in infectivity and pathogenicity. Hopefully additional funding will be available through the Covid relief package to be assigned by the incoming Administration.

 

With recognition of a similar variant in the U.S. this past week we can expect that community transmission during  Christmas travel will have disseminated this strain widely. It is only the dearth of sequencing assays that has failed to reveal the problem of emerging variants. "Seek and ye shall find" is the applicable catchphrase.


 

A New Year’s Wish List

12/27/2020

By any standards 2020 was an annus horribilis.  Without recounting the tribulations of the past twelve months, we could rather turn to an anticipation of 2021.  Our wish list includes the most desired changes from 2020:

  • Uppermost will be control of COVID-19.  We now have two mRNA vaccines available and we trust that the acceptance of these vaccines and their deployment will be rapid, free of complications and above all effective.  Concurrently we anticipate compliance by our population in public health measures extending through summer that will be necessary until an acceptable level of immunity is attained in our population.
  • A restoration of the economy is anticipated.  We have incurred a high level of public sector and private debt as a result of COVID. Our economy has, with the rest of the World, been seriously impacted.  We earnestly hope that sound fiscal management will prevail to restore the previous way of life we enjoyed before the advent of COVID-19.  Restoration of the economy accompanied by relaxation of COVID restrictions should alleviate hunger and misfortune among so many of our fellow citizens. Teaching through K-12 and university instruction will resume, although it is recognized that disruption in 2020 will have placed many of our students behind their anticipated development levels, requiring remediation.
  • We look forward to a smooth transition between the outgoing and the incoming Administrations with continuation of programs that were beneficial and support for American traditions.  Extremism from both the right and left must be discouraged and complete acceptance of the integrity of our Constitution must be maintained. 
  • We hope that extremes of weather, related to climate change will be less evident in 2021.  With the anticipation of the decline in La Nina that has apparently peaked, we hope to have fewer hurricanes and more even distribution of rainfall, preventing both flooding and drought.  The epidemic of fires west of the Rockies should hopefully abate, allowing restoration of the ecology of seven states.
  • We look forward to better relations with our allies and respect from our adversaries.  Restoration of our participation in international bodies, such as the WHO and improved interaction in the WTO and multinational trade agreements will benefit both our industrial and agricultural sectors.
  • It is hoped that catastrophic livestock diseases, including avian influenza, African swine fever, and foot and mouth disease, will spare our herds and flocks despite their prevalence in other nations.
  • We wish our row-crop farmers bountiful harvests. This should restore income, since farmers were dependent on government programs for 40 percent of revenue in 2020. Higher yields will lead to lower ingredient prices that spiked during the last quarter of 2020 and are still rising.
  • We wish our elected representatives and senators at the national level, and our state and local legislators, wisdom, objectivity, and freedom from the strictures of parochialism in their deliberations and decisions.  We hope for a new spirit of bipartisanship and cooperation rejecting the coercion and divisiveness that were apparent in 2020.

 

With restoration of our economy following control of COVID, we can look forward to improved purchasing power of our consumers and more favorable production margins.  We hope to release the inherent creativity and productivity of the U.S. poultry industry for the mutual benefit of our companies, their workers, and our consumers.

 

As I dictate an editorial on Christmas Day in 2021, I look forward to reflecting with you on an annus mirabilis, encompassing our current hopes and aspirations.

 

Barbara and I extend to you, your families, and colleagues

our warmest wishes for health and prosperity in the coming year.


 

Moderna COVID Vaccine Deployed-Vaccination Encouraged

12/23/2020

According to General Gustave Perna, Chief Operating Officer of Operation Warp Speed, more than six million doses of the Moderna mRNA vaccine were shipped to 3,200 sites during the week beginning Monday, December 21st.  During the previous week, 272,000 doses of the Pfizer vaccine were administered according to the Centers for Disease Control.  It is noted that the Moderna vaccine that does not require the rigorous -90 F storage and transport temperature for the Pfizer product can transported at regular refrigeration temperature will be more acceptable for rural areas and small vaccination centers.

 

The initial vaccinations were administered to frontline healthcare workers.  On Sunday, December 20th the CDC AdvisoryCommittee prioritized adults 75 and older and frontline service workers to receive vaccines.  In the subsequent phase, adults between 65 and 75 and those between 16 and 64 with high-risk predisposing conditions and other essential workers will be vaccinated. 

 

It is anticipated that 20 million doses of  vaccine will be distributed by the end of 2020, although it is recognized that an equivalent volume has been held in reserve for the essential second dose of both the Pfizer and Moderna vaccines. The rollout of vaccine has demonstrated a slower rate of administration compared to availability even though the first recipients have been in hospitals with optimal resources. Logistical problems will obviously be resolved with resourcefullness and experience during the early weeks of 2021.

 

Health authorities, including Dr. Carlos del Río, Associate Dean of the Emory University School of Medicine, have warned that precautions to prevent transmission must be maintained as it will be a number of months before adequate numbers of the U.S. population achieve immunity. The U.S. has recorded almost 18 million confirmed cases with 320,000 fatalities since COVID-19 emerged.  On Friday, December 18th almost 250,000 new infections were recorded with an average of 2,500 deaths per day during the preceding week.

 

There is guarded optimism over acceptance of COVID vaccines.  Despite mischievous and misleading negative comments, the approval of the vaccine and initiation of administration have resulted in an increase in the number of citizens indicating their intent to be vaccinated. A concerning proportion of the population of western European nations and the U.S. still have reservations as to safety. This is in part due to the speed at which the vaccines were developed, distrust of governments and the pharmaceutical industry in general and a concerted campaign by anti vaxxers using the internet.

 

Commentators have suggested that opposition to vaccination, extending back to the 18th century was essentially based on religious views that vaccination was contrary to “God’s will”.  As noted in the Charlemagne column in the December 12th edition of The Economist,  Laurent-Henri Vignaud, a historian at the University of Bourgogne, observed that opposition to vaccination is now based on political considerations with a “strong correlation between doubting vaccines and voting for populist parties”.  This sentiment is supported by Dr. Jonathan Kennedy of the Queen Mary University of London.  News reports suggested that a high proportion of workers at homes for the elderly are disinclined to be vaccinated, this is unfortunate since this cohort is dealing directly with the most vulnerable members of our population and could serve as asymptomatic spreaders. Surveys show that 40 percent of those interviewed in Poland and Hungary and 46 percent in France stated they would reject a COVID-19 vaccine if offered. Health authorities expect that the increasing incidence rate of COVID accompanied by restrictions on normal social and economic activity will encourage acceptance of vaccination. It is hoped that with appropriate leadership and example, vaccination will be adopted by a high proportion of eligible recipients.

 

The Charlemagne column concludes that “the most effective vaccine against anti-vax nonsense would be for governments to roll out their COVID-19 vaccination programs as quickly and smoothly as possible with a minimum of disruption.  When elites do their jobs well populists and cranks have less to froth about”.


 

Tom Vilsack to be Nominated as USDA Secretary

12/09/2020

According to news reports President-elect Biden intends to nominate Tom Vilsack as Secretary of the USDA based on his experience, prospects for easy conformation as a non-controversial nominee. Vilsack is a known quantity having served previously as Secretary of the USDA for eight years. He is expected to bring stability to the Department and reduce uncertainty experienced by a stressed agricultural community facing the challenges of COVID-19, a depressed economy and trade disputes.

 

Based on previous actions and decisions the following can be expected of a Vilsack tenure at the  helm of the USDA:


Secretary-Designate Tom Vilsack
  • Continued support for ethanol production

 

  • Revival of regulations framed in 2017 under GIPSA, favoring contractors and family farms.
  • Implementing the recently enacted Farm Bill and to initiate consultations with Congress to frame legislation leading to the next farm Bill

 

  • Maintain crop insurance programs

 

  • Adopting a more active role in advancing sustainability and averting climate change through application of proven science

 

  • Restoring Obama-era nutritional standards for school feeding

 

  • Engendering bipartisanship in Congress to the benefit of his farmer constituency

 

  • Continuing a Departmental focus on farmers in comparison to a consumer-oriented approach as promoted by the left-wing of the Democratic Party

 

  • Moderation in trade disputes and restoration of levels of commodity exports that pertained prior to the advent of the 2017 trade war with China

 

  • Appointment of competent and experienced subordinate undersecretaries and deputy secretaries, coupled with a higher degree of professionalism in decision-making. The programs and policies of the USDA will be more influenced by science than by political considerations as compared to the previous Administration.

 

  • Promote a rational immigration policy providing security for both farmers and workers

 

Secretary Vilsack will approach the position with considerable experience as a previous two-term cabinet member and will have the support of the President, having campaigned for Candidate Biden. Secretary-Designate Vilsack has the expressed support of Senator Chuck Grassley, a past-Chairman of the Senate Agriculture Committee and a force in U.S. agriculture. He has already received indications of support from the American Farm Bureau and the National Farmers Union.

 

Immediate challenges will be to fill vacant positions with suitable nominees who can be confirmed, address the issue of food insecurity exacerbated by COVID-19 and to wean producers from Government support that represented 40 percent of agricultural income in 2020.


 

Evaluation of Masking to Prevent COVID-19

12/02/2020

It is generally accepted by public health authorities that until an effective vaccine is deployed and achieves immunity in 60 to 70 percent of the U.S. population, prevention will have to depend on more elementary protective measures.  These include masking, avoiding large gatherings, and maintaining social distancing in addition to increasing air exchange rates in confined areas such as packing plants.

 

The wearing of masks to prevent what is predominantly an aerosol transmitted infection is generally accepted.  Regrettably in months leading up to the November general election masks were politicized, deterring adoption of this elementary and inexpensive preventive measure, especially in rural communities.

 

Models evaluated by the University of Washington Institute for Health Metrics and Evaluation predict that if 95 percent of state residents wore masks regularly in public, more than 1,400 COVID-19 deaths would be averted through March 1st.  The rapidly ascending incidence of COVID-19 in all states, and especially those in the Pacific Northwest, has led to greater mask compliance.  The University of Washington Institute determined that the use of masks, when outside homes, increased from 50 percent in July to 70 percent in mid-November.  Dr. Judith Wasserheit, Chair of the University of Washington Department of Global Health, stated “I think we all recognize that COVID-19 infections are exploding and the data are clear that masks are one of the best prevention tools we have.” 

 

Accordingly, the University of Washington will undertake a study of the motivation to wear masks and to determine how health departments and other state and local agencies should focus messaging to increase compliance.  The University of Washington study will be sponsored by the Washington Department of Health. Data will be collected among communities across King County, including the metropolitan area of Seattle. Emphasis will be placed on retail outlets including supermarkets and big-box stores, neighborhood markets and parks to determine the proportion of individuals wearing masks with respect to gender and age.  The intent of the study is to determine locations where mask usage is lowest and to establish the demographics of non-compliers. It is anticipated that other counties may follow with their own investigations using the King County template.

 

Opponents to wearing masks are frequently deniers of COVID-19 as a significant infection. Apparently those who reject the reality of the pandemic fail to recognise 13 million diagnosed cases and 265,000 fatalities since January 2020. Those opposed to mask-wearing invoke discomfort and peer pressure. They are frequently also anti-vaxxers and regard recommendations by health authorities as an intrusion on personal freedom.

 

To justify noncompliance, pseudoscientific justifications gleaned from the internet are invoked.  A frequently quoted study that did not demonstrate any significant advantage from masking was conducted in Denmark. The trial compared the incidence rate of COVID-19 among volunteers either wearing or not wearing masks in public.  A total of 3,030 participants were assigned to the mask group and 2,994 to the controls.  Of the 4,862 who completed the study, 1.8 percent of the masked group contracted COVID-19 compared to 2.1 percent of the non-masked controls representing a non-statistically significant difference.  The trial was flawed by a low incidence rate over the duration of the comparison and the fact that the masked group effectively only complied with the mask requirement in public for half of the time.  It is regretted that this publication has been misquoted and used by opponents of masking, despite the obvious deficiencies in experimental design and execution.

 

It is reiterated that until immunization is achieved through extensive vaccination, masking and other common sense precautions as recommended by public health authorities and reputable scientists will be essential to suppress the escalating incidence of COVID-19. Without suppressing the incidence rate of COVID-19 we will not be able to restore our economy and return to a “new-normal” way of life.

 

*Bundgaard, H. et al Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers. Annals of Internal Medicine. doi.org/10.7326/M20-6817


 

Review and Authorization of COVID Vaccines

11/25/2020

It is axiomatic that restoration of our economy will be dependent on an effective vaccine accepted by at least 60 percent of our population. During the past two weeks, Pfizer and Moderna have publicized preliminary data in press releases indicating over 90 percent effectiveness of their respective mRNA vaccines. Both Pfizer and Moderna conducted their trials in the U.S. in addition to other nations and have submitted data to the FDA to be considered for emergency use authorization. (EUA).

 

It is noted that the Pfizer-BioNTech vaccine requires a critical cold chain that will represent logistic problems in distribution.  The Moderna vaccine has a less rigorous temperature requirement that will facilitate widespread administration especially in rural areas.

 

 On Monday, November 23rd, AstraZeneca noted that their adenovirus-vectored COVID vaccine was up to 90 percent effective when administered to recipients according to a specific dose sequence, as part of their Phase-3 trial. Using two similar full doses they achieved 60 percent protection. The AstraZeneca vaccine developed in collaboration with Oxford University is a more conventional vaccine than the Moderna and Pfizer mRNA products and is based on a simian (Ad5) adenovirus vector with inserted genes coding for SARS-CoV-2 spike protein. Two doses of this vaccine are required but the product can be stored under conventional refrigeration. AstraZeneca will complete their dossier before the end of the year. The Russian ‘Sputnik-5’ vaccine is similar in principle to the AstraZenica vaccine but uses two different adenovirus vectors for the first (Ad26) and second (Ad5) doses. The Novovax subunit vaccine has yet to be tested.

 

On Sunday November 22nd Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID) explained the review sequence to approve a COVID vaccine.

 

  • The company manufacturing the vaccine must compile data, subjected to rigorous statistical analysis in a dossier including details of the development and manufacture of the vaccine, the protocol for trials and the results with an interpretation
  • The portfolio is reviewed by NIAID
  • The company submits the application to the U.S. Food and Drug Administration to be critically and comprehensively reviewed by career scientists with specific expertise in the fields of virology, statistics, pathology and infectious diseases.
  • The Vaccines and Related Biological Products Advisory Committee external to the FDA also reviews the data and makes a recommendation. This body is scheduled to convene on December 10th having previously studied the submission by each applicant for approval.
  • The Commissioner of the FDA reviews the recommendations of the internal career scientists and the Advisory Committee before granting emergency use authorization
  • Permanent approval is subject to a formal and more rigorous review including safety data and duration of immune response based on longer-term application over a larger number of recipients

 

The application by AstraZeneca may be delayed in the U.S. given questions over efficacy in relation to dose and review of their Phase-3 trial that was conducted simultaneously in the U.S., South Africa, Brazil, the UK and other EU nations.  It is anticipated that emergency use authorization will be granted by regulators in the UK and EU based on an evaluation of results and that this vaccine will be distributed in both industrialized and developing nations.

 

In commenting on the reported 95 percent efficacy of the Pfizer and Moderna vaccines, Dr. Anthony Fauci stated, "it can't get much better than that.  I think what people need to appreciate - and that’s what I have said like maybe a hundred times in the last week or two - is the process by which a decision is made".  Facui noted that Dr. Stephen Hahn, the Commissioner of the FDA has publicly vowed that he will accede to the opinions of the career scientist and the Advisory Board and his decision will be independent of any political pressure.  The companies producing vaccines under the DHHS ‘Warp Speed’ program issued a statement in October amid pre-election rhetoric and implied pressure that they would only submit data to FDA when they were convinced that their respective vaccines were both safe and effective as demonstrated in approved Phase-3 trials.

 

The question of acceptability is now the major challenge facing immunization of the U.S. population.  Our citizens must be confident that vaccines have been thoroughly tested in order to achieve a compliance rate in excess of 60 percent of those eligible using a two-dose program.  Currently there is considerable concern over efficacy and safety as evidenced by surveys that show a low intent to receive the vaccine when it becomes available.  Administering the small quantity of available vaccine in late December to medical care-givers, first responders and those at high risk of complications will improve confidence. The fact that there is now interaction and cooperation between the current and the incoming administration will ensure a smooth transition with seamless execution. Hopefully initial experience denoting acceptable immunity and freedom from adverse reactions will lead to high rates of uptake when vaccines become available to the general public in adequate quantities during the second quarter of 2021 onwards.


 

Smithfield Foods Settles with Plaintiffs over North Carolina Hog Nuisance Cases

11/23/2020

In 2014, five hundred residents of homes in close proximity to farms either owned by or contracted to Smithfield Foods filed nuisance lawsuits.  Five cases went to trial resulting in jury verdicts in favor of plaintiffs who were awarded substantial direct and punitive damages.  In accordance with a hastily enacted state law, punitive damage awards were reduced to approximately $100 million.  Smithfield Foods appealed to the U.S. Circuit Court of Appeals in Richmond, VA claiming irregularities in the trials heard by the U.S. District Court in Raleigh, NC. Two of the judges on the panel of three denied the appeal for a new trial with one dissenter, Judge G. Steven Agee.

 

Subsequent to the denial of appeal Smithfield decided to settle with the plaintiffs.  Keira Lombardo, Chief Administrative Officer spun the legal outcome stating, “In the midst of a global pandemic, where food shortages are commonplace it is now time to keep our full attention on the important work of producing good food in a responsible and sustainable way rather than returning to the court for what would be an ongoing and distracting litigation.” 


NC Hog farm with lagoons

Evidence in the five trials showed that there were alternatives to the traditional system of storing hog waste in lagoons followed by spraying on pasture resulting in odor complaints.  Plaintiffs’ attorneys claimed that the company was aware of the problems caused by their contractors’ manure disposal and were cognizant of technical solutions, but “willfully chose not to do anything about it.” According to plaintiffs’ attorneys, Wallace and Graham, the law firm opted to sue Smithfield Foods rather than the contractors based on the depth of the pockets of the integrator Smithfield a subsidiary of the WH Group of China.

 

 In his opinion, Judge J. Harvie Wilkinson III referred to “outrageous conditions at Kenlaw Farms.”  citing neglect of both animal and human welfare.  The opinion which has now entered case law supports the contentions of Senator Cory Booker [D-NJ] and Senator Elizabeth Warren [D-MA] who are promoting legislation to ban all CAFOs.  Judge Wilkinson referred to the “decades-long transition to concentrated animal feeding operations that lays bare the connection between animal welfare and human welfare and the consequences of its breach.”

 

In reality the problem is not attributable to either the large numbers of hogs held on a single farm or their stocking density. Generation of odor and contamination of groundwater is due to the primitive waste disposal system inconsistent with the volume of fecal material produced.  As with egg-production farms that previously used flush removal of manure with lagoons systems, the the installations on hog-CAFOs in North Carolina provided inadequate storage and relied on frequent spray application on limited areas of pasture for disposal.  If Smithfield Foods and other hog producers wish to remain in North Carolina and possibly other states, given the precedent created by these five cases, alternate technology including anaerobic digestors will be required at considerable capital costs.

 

Given the prospect of  more stringent environmental regulations to be imposed by the incoming Administration and the reaities of tort law, all operators of CAFOs including egg-production complexes should consider the potential for nuisance and environmental degradation from their operations. Many existing and new complexes have invested in manure drying and composting installations to turn the liability of manure into a positive income stream. 

 

The Smithfield Foods cases will have profound implications for all intensive livestock production. The technology to be a good neighbor and steward of the environment is available and the clock is ticking.


 

Immunization of the American Population Against COVID-19

11/16/2020

It is thankfully apparent that at least the U.S. now has two COVID-19 candidate vaccines represented by the Pfizer-BioNTech and Moderna Therapeutics mRNA-based products. Both vaccines have proven effective and safe as demonstrated by extensive field trials reported in press releases by the two companies. Emergency Use Approval by the Food and Drug Administration is expected in late December following expedited but thorough scientific review.

 

Both vaccines are based on mRNA coding for spike proteins of the virus that stimulate production of antibodies. Developed under the inappropriately named “Warp Speed” program and funded to a level of $10 billion both vaccines require and initial dose followed by a second ‘booster’ at intervals of 3 to 4 weeks depending on type and future field experience.

 

The Federal government funded the developers of vaccines to concurrently refine development of the antigenic mRNA and to establish a production capability so that vaccines would be available shortly after FDA approval.  Approximately 50 million doses of the two vaccines will be ready for distribution during the first two months of 2021 with larger quantities thereafter.

 

The Pfizer vaccine must be stored at -100F but remains potent for 10 days at -78F corresponding to the temperature of dry ice. The Moderna vaccine can be stored at -4F for extended periods but requires a temperature of 35 to 45F corresponding to a conventional refrigerator, for no longer than 30 days.

 

The Federal government has arranged for the military to coordinate the acquisition and distribution of vaccine and has stockpiled adequate quantities of vials, needles and other consumables to support a nationwide vaccination program. It is however evident that the commercial sector with experience in cold-chain logistics will have to be involved. Fedex and UPS will be the most likely carriers, medical supply companies such as McKesson will provide local storage and distribution. Pfizer has planned a $2 billion program to install low-temperature freezers in warehouses and has developed transport modules containing dry ice to support their product.

 

Pharmacies eligible under the Federal Pharmacy Partnerships Strategy for COVID-19 Vaccination will participate in administration to recipients.  This may be impractical since the proposed COVID vaccines are more difficult to store and inject than an annual flu-shot.  Even if half our population agree to receive the vaccine, with a two-dose program it will be necessary to administer 310 million doses in eight to ten months subject to the availability of vaccine. Given the stringent requirements for storage and handling of the Pfizer vaccine, it isdoubtful whether conventional pharmacies, whether as stores or located in supermarkets will be able to achieve the required rate of administration or to maintain viability of the product. (Given paperwork, an available pharmacist and no line of people waiting, my annual influenza vaccination in September took 30 minutes in a CVS pharmacy). Given the logistic complications involved and the need for rapid administration and to establish a reliable database, it will probably be necessary for recipients to attend vaccination clinics at hospitals, national guard armories or convention centers equipped to store and handle vaccine that must be administered at a high rate.

 

The most pressing problem relates to whether citizens are willing to take the vaccine.  Various surveys have shown a projected compliance rate of 20 to 50 percent.  Unfortunately, the question of vaccination was politicized along with many aspects of the prevention and control of COVID including the collection, reporting and analysis of data. The selection of the term "Warp-Speed" for the development of the program was extremely inappropriate since it created an image of speed at the expense of science.  Many prospective recipients are concerned over safety and to a lesser extent efficacy given the statements from Administration spokespersons and contradictory information from established public health specialists. Prospective recipients of vaccine have been confused by deliberate underplaying of the gravity of the Covid-19 epidemic in the U.S. We have been subject to official denial regarding the severity of the infection and the need for testing in the face of ascending incidence and fatality rates. The control of COVID-19 by non-medical modalities has not been supported by the Federal government and has been delegated (or abrogated) to states. Confidence in vaccines among our polarized citizenry has been adversely affected by denigrating and criticizing established and recognized professionals in the areas of epidemiology and those with experience in developing and administrating vaccines and the control of infectious diseases. Suspicion that agencies including the FDA, NIH and the CDC were subject to political pressure to approve ineffective therapeutics as a “quick-fix” expedient and downplaying the significance of COVID-19 have all generated a disinclination to be at the head of the line to receive a vaccination.

 

Fortunately, the pharmaceutical industry and specifically the manufacturers of vaccines issued a joint statement in October confirming that they would only submit data and request FDA approval when they were confident that the vaccine was both safe and effective based on field trials. To this point there was concern that November 3rd was a critical date for approval based on political considerations.  It will be the responsibility of the incoming Administration to restore confidence and to convince the public that the FDA will base approval on evaluation only of scientific data.

 

It is considered significant that the first action taken by president-elect Biden was to establish a COVID taskforce of twelve leading academics all with practical experience in areas of epidemiology and public health. Cooperation in the form of a joint transitional task force on planning and execution of a difficult vaccination program will be essential to successful protection against COVID-19 and saving lives.

 

It is an established fact that until COVID-19 is controlled, there cannot be a restoration of either a normal life or our economy.  The alternative approach of ignoring COVID and making belief that it did not exist has resulted in over 10 million cases, 250,000 fatalities and billions of dollars in cost and hardship.  We cannot look back but must make the best use of available vaccines, prioritized to our first line responders and those with predisposing conditions.  Hopefully the initial vaccination program will be successful and that progressively more citizens will be immunized.  The theory of herd immunity from natural exposure has been disproved and is now the preoccupation of political hacks, science deniers, charlatans and mountebanks. Ultimately, to control COVID-19 we will have to rely on a combination of common-sense precautions combined with effective vaccines.  Until a high proportion of our population is immunized, we will be dependent on masking, social distancing and avoiding crowds. These precautions will be required as we attempt to "flatten the curve" for the third time.

 

We owe our scientists both in basic molecular biology and applied vaccinology our gratitude.  We are indebted to first responders for the care of those who have contracted COVID and we extend our condolences to the bereaved among us as every one of the quarter million fatalities was once a living functioning person with a family, aspirations and future opportunities.


 

Questions over China’s Commitment to Phase-One Trade Agreement

11/03/2020

Agricultural commodities represent 22 percent of the products covered in the January 2020 Phase-One trade agreement with China.  Despite optimistic projections by the office of the U.S. Trade Representative, actual deliveries of commodities have fallen short of the commitment entered into by China.  Orders lagged through the 2019-2020 marketing year although there has been an increase through September and into the subsequent market year. It is calculated that China will need to import 62 percent of their commitment during the fourth quarter of the current year to comply with the 2020 target.

 

Soybeans comprised 60 percent of U.S. agricultural exports to China in 2017. Following the initiation of the trade conflict, China turned to other suppliers of soybeans resulting in U.S. exports through September 2020 attaining half of pre-2018 levels.  An added complication was the reduced demand by China following the loss of up to 30 percent of their hog herd as a result of African swine fever.  Although China requires corn and is now importing this commodity the impetus is partly a result of a 2019 World Trade Organization ruling concerning unfilled tariff rate quotas. Despite the requirement for imported corn China turned to other suppliers than the U.S. 

 

The trend in exports of both industrial goods and agricultural commodities from 2018 onwards suggests that trade wars are not “short and easily won”.  Tariffs on imported goods are borne by consumers not the exporting nation.  Federal subsidies to the agricultural sector in 2019 and 2020 to compensate for losses in exports were effectively at the expense of taxpayers, adding to the national debt.

 

Trade disputes with nations such as China should be resolved by negotiation and the use of international agencies such as the WTO rather than embarking on self-destructive tariff wars that invite retaliation.  Confronting the World’s second largest economy should not have involved a precipitous head-on confrontation in 2017. Resolution of real grievances could be achieved more easily through cooperation and collaborative action with our erstwhile allies who are faced with similar problems of China extending subsidies to state-owned enterprises, coercive trade practices and theft of intellectual property.


 

The Need to Control COVID-19

10/31/2020

The statement by White House Chief of Staff, Mark Meadows, in a CNN interview on Sunday, October 25th is cause for concern.  He averred, “we are not going to control the pandemic, instead we will focus on vaccines, therapeutics and other mitigation areas.”  In the week running up to the November 2020 election, the U.S. has recorded 9.0 million diagnosed cases and 230,000 fatalities. Incident cases rose to 80,000 per day with more than 1,000 fatalities.  Both the incidence and mortality rates are understatements given deficiencies in testing and assigning the cause of death.  Worldwide there have been 44 million diagnosed cases with over 1.4 million deaths.  It is evident that the U.S. is experiencing an upsurge in cases with daily reports of new cases approaching 80,000 with close to 50,000 currently hospitalized.  The COVID pandemic has profoundly impacted the economy of our nation as evidenced by high unemployment, low and fluctuating earnings reported by public companies and a stock market that shed close to six percent of shareholder value over four consecutive trading days.

 

The actions of the Administration have been widely criticized, both by public health specialists within the U.S. and by the World Health Organization.  Effectively, the Administration has adopted the Swedish model and has embraced the Great Barrington Declaration.  Simply put, this approach involves relaxation of most restrictions but with attempts to protect the elderly and those with predisposing conditions, including diabetes, obesity, and immunosuppression.  These demographics unfortunately represent close to a third of our population. 

 

Although politically comforting and expedient, science does not support the principle of “herd immunity” with respect to COVID. Herd immunity has never been achieved with any disease absent an effective vaccine stimulating durable immunity.  Evidence from Stockholm suggests that the level of antibodies in the population is far lower than the threshold of at least 50 percent of the population required to meaningfully control the infection.  There is insufficient knowledge concerning the antibody status of those recovering from COVID-19 irrespective of whether they were asymptomatic or required supportive treatment. The proponents of herd-immunity appear to ignore the long-term consequences of infection. The virus is pantropic in its effect with both cardiac and neural changes in addition to fatigue in the so-called “long haulers”.  

 

Prominent epidemiologists have calculated that without currently-known measures including masking, maintaining social distance, and avoiding large gatherings, cases from COVID-19 will  be measured in the millions over the coming year with a proportional rise in fatalities.  It is a disquieting thought that correcting for the relative sizes of the U.S. population, the 1918 outbreak of H1N1 influenza resulted in as many fatalities expressed as a rate by October 1918 as the U.S. has experienced with COVID.

 

Epidemiologists and public health specialists have issued the John Snow Memorandum to counter the fallacies and illogic of the Great Barrington Declaration.  They characterize the approach to ignoring known preventive measures to create herd immunity as a gigantic gamble, hoping for a rapid  return to pre-COVID social and economic activities.

 

It may be inferred from the statement by Chief of Staff Mark Meadows that the Administration will depend on protection from an as yet unavailable and unapproved vaccine.  Despite the efforts of the major pharmaceutical manufacturers, a vaccine will not be generally available until the beginning of 2021.  Pfizer, the apparent leader in the race, has yet to conclude the evaluation of their Phase-3 trial involving 40,000 participants conducted in the U.S., Brazil, Argentina, South Africa, Germany, and Turkey.  Results of the trial should be available by the end of November, after which statistical analysis and peer review will be required before approval by the FDA.  Pfizer anticipates 164 cases of COVID in their trial but an interim evaluation will consider efficacy after 35 cases have been diagnosed in the trial population.  If 26 are in the placebo group, the vaccine could be approved by the FDA on the basis of 50 percent efficacy.  Moderna will evaluate their vaccine after 53 cases and AstraZeneca after 75 COVID diagnoses in their respective trial groups. 

 

Even if a vaccine is approved at the beginning of January 2021 only sufficient quantities will be available to commence distribution to priority groups including first responders, the elderly, and those with predisposing conditions. Two doses with a month interval will be required to stimulate durable immunity. Appropriate monitoring will be required for at least three months after initiating mass vaccination to distinguish between any possible adverse vaccine reactions and the large number of spontaneous but unrelated clinical conditions and mortalities that are sure to occur among recipients of the vaccine.

 

Mass vaccination will impose logistic challenges in distributing and administering a biological product that requires a critical cold chain.  Simply stating that “the Army will do it” is more an aspiration than a specific plan.  The reluctance of a high proportion of the U.S. population to receive a vaccine will obviously reduce the proportion of those that become immune within the population.  It is yet unknown whether development of antibodies will actually provide protection from clinical effects or reduce the extent of virus shedding.  An additional unknown is the durability of antibody levels in the face of ongoing challenge and the possible mutation of SARS-CoV-2 over time.  It is possible that as with other coronavirus infections, annual re-vaccination may be required, but this challenge is in the future. 

 

It is accepted that there will be a delay in obtaining sufficient quantities of presumably effective vaccines, logistic complications associated with distribution and administration and reluctance to be immunized. This suggests that we must continue to adopt measures that have been shown to be effective in nations such as South Korea, Taiwan, and even China.  These nations adopted rapid testing for antigen with strict quarantine of those shown to be exposed, contact tracing, masking, and social distancing.  The countries that have achieved the  greater success in controlling COVID have followed the advice of scientists and have a culture that accepts masks and are willing to conform to health directives.

 

From the perspective of our industry, we must apply scientific principles, eschewing quick fixes and false prophets.  With the onset of winter we must ensure a high level of immunity against seasonal influenza, that will be a complicating factor both with  respect to the diagnosis and clinical response to COVID infection.  We must increase the efficiency of testing with quarantine and contract tracing and apply common sense in our business and social activities. 

 

Experience over the past nine months has shown that COVID cannot be ignored.  There is no evidence that the infection will spontaneously disappear and without appropriate control measures, we could experience a replay of the 1918-1920 influenza pandemic.  We have yet to receive an effective vaccine, there is no consistently effective or specific therapeutic agent (the Administration ‘cure’). We are relying on the stretched resources of our medical community who are reducing mortality by administering supportive therapy and a high level of care.

 

COVID-19 dominates all aspects of our life at present and we will not return to normality until it is controlled.  We have a collective responsibility to respond to sound scientific advice and over the intermediate term, suppress the incidence rate especially in rural areas where our farms and packing plants are located.


 




































































































































































































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