Posted on by ITadminLast updated

Emergency Temporary Standards Reject: COVID-19 .

Reject Proposed Revisions of COVID-19 Prevention Emergency Temporary Standards. Physicians for Informed Consent Letter to Cal/OSHA.

California Department of Industrial Relations
Occupational Safety and Health Standards Board
2520 Venture Oaks Way, Suite 350
Sacramento, CA 95833
OSHSB@dir.ca.gov

RE: Reject the proposed revisions of Cal/OSHA COVID-19 prevention requirements

Dear Board Members,

On behalf of Physicians for Informed Consent, I am writing regarding the proposed revisions of the Cal/OSHA COVID-19 prevention requirements,1 which will be considered at your June 17, 2021, board meeting. The updated guidelines aim to treat California workers differently depending on their COVID-19 vaccination status. However, key scientific data demonstrate that discrimination is unwarranted. Before you implement a new policy for the workplace, I urge you to consider the following:

1. There is no evidence that COVID-19 vaccines prevent the spread of SARS-CoV-2 or COVID-19. Therefore, there is no scientific justification to treat vaccinated people differently from unvaccinated people.

Clinical trials for the Pfizer-BioNTech, Moderna, and Janssen (Johnson & Johnson) COVID-19 vaccines were not designed to observe asymptomatic infection with SARS-CoV-2 or the effect of the vaccine on the spread (transmission) of COVID-19. Consequently, in its briefing document for each vaccine, the U.S. Food and Drug Administration (FDA) states that “it is possible that asymptomatic infections may not be prevented as effectively as symptomatic infections” and “data are limited to assess the effect of the vaccine against transmission of SARS-CoV-2 from individuals who are infected despite vaccination.” Furthermore, “additional evaluations including data from clinical trials and from vaccine use post-authorization will be needed to assess the effect of the vaccine in preventing virus shedding and transmission, in particular in individuals with asymptomatic infection.”2-7

2. There is evidence that previous SARS-CoV-2 or COVID-19 infection is more effective at preventing SARS-CoV-2 or COVID-19 infection than at least one of the COVID-19 vaccines. Therefore, those previously infected with COVID-19 should have at least the same rights as those vaccinated for COVID-19.

The Janssen (Johnson & Johnson) COVID-19 vaccine clinical trial included over 2,000 subjects that had contracted SARS-CoV-2 before the study. The trial recorded the incidence of COVID-19 in that unvaccinated group at least 28 days after the vaccination of the other subjects in the study. The COVID-19 incidence of the unvaccinated group with prior SARS-CoV-2 infection was 0.1% (2/2,021), whereas the COVID-19 incidence of vaccinated subjects was 0.59% (113/19,306). These data suggest that there are six times more cases of COVID-19 in vaccinated subjects than in unvaccinated subjects previously infected with SARS-CoV-2. This also means that an unvaccinated person previously infected with SARS-CoV-2 has 99.9% chance of being protected from a repeat infection.7,8 Of note, as of April 17, 2021, there have been 165.7 million SARS-CoV-2 infections in the U.S., which is 50.2% of the U.S. population.9

Treating people differently depending on their COVID-19 vaccination status is not based on science. As Cal/OSHA is responsible for ensuring the safe and healthful working conditions for all workers, we urge you to reject the proposed guideline revisions and instead implement a policy that ensures all employees are treated the same, regardless of their vaccination status. We are here to assist you in these highly technical matters and welcome further discussion.

Respectfully,
Shira Miller, M.D.
Founder and President
Physicians for Informed Consent

References

  1. Cal/OSHA. Standards presentation to California Occupational Safety and Health Standards Board; 2021 Jun 11. https://www.dir.ca.gov/oshsb/documents/Jun172021-COVID-19-Prevention-Emergency-txtcourtesyReadoption.pdf.
  2. U.S. Food and Drug Administration, Vaccines and Related Biological Products Advisory Committee. FDA briefing document: Pfizer-BioNTech COVID-19 vaccine. Vaccines and Related Biological Products Advisory Committee Meeting: December 10, 2020. https://www.fda.gov/media/144245/download.
  3. Physicians for Informed Consent. Pfizer-BioNTech COVID-19 vaccine: short-term efficacy and safety data. Jun 2021. https://www.physiciansforinformedconsent.org/COVID-19-vaccines.
  4. U.S. Food and Drug Administration, Vaccines and Related Biological Products Advisory Committee. FDA briefing document: Moderna COVID-19 vaccine. Vaccines and Related Biological Products Advisory Committee Meeting: December 17, 2020. https://www.fda.gov/media/144434/download.
  5. Physicians for Informed Consent. Moderna COVID-19 vaccine: short-term efficacy and safety data. Apr 2021. https://www.physiciansforinformedconsent.org/COVID-19-vaccines.
  6. U.S. Food and Drug Administration, Vaccines and Related Biological Products Advisory Committee. FDA briefing document: Janssen Ad26.COV2.S vaccine for the prevention of COVID-19. Vaccines and Related Biological Products Advisory Committee Meeting: February 26, 2021. https://www.fda.gov/media/146217/download.
  7. Physicians for Informed Consent. Janssen (Johnson & Johnson) COVID-19 Vaccine: Short-Term Efficacy & Safety Data. May 2021. https://www.physiciansforinformedconsent.org/COVID-19-vaccines.
  8. U.S. Food and Drug Administration, Vaccines and Related Biological Products Advisory Committee. FDA briefing document: Janssen Ad26.COV2.S vaccine for the prevention of COVID-19. Vaccines and Related Biological Products Advisory Committee Meeting: February 26, 2021. Table 14: vaccine efficacy of first occurrence of moderate to severe/critical COVID-19, including non-centrally confirmed cases, with onset at least 14 or at least 28 days after vaccination, by baseline SARS-CoV-2 status, per protocol set; 30. https://www.fda.gov/media/146217/download.
  9. Statistical Analysis of the Frequency SARS-CoV-2 Infections in the United States
    A Stanford University systematic review that included 69 antibody studies estimated that the COVID-19 infection fatality rate (IFR) in the United States ranges from 0.3% to 0.4%.a Data analysis herein uses the midpoint of that range, 0.35%. An IFR of 0.35% is also supported by an analysis published in Clinical Infectious Diseases that estimated that there were 44.8 million symptomatic COVID-19 illnesses in February–September 2020.b Additionally, since 33% of all SARS-CoV-2 infections are asymptomatic,c there were an estimated 66.9 million (44.8 million/[100%-33%]) total number of SARS-CoV-2 infections in that time period. There were also 213,000 COVID-19 deaths in February–September 2020,d resulting in a COVID-19 IFR of 0.32% (213,000/66.9 million). As of April 17, 2021, there have been about 580,000 COVID-19 deaths in the U.S.d As the COVID-19 IFR is about 0.35%, as of April 17, 2021 there have been about 165.7 million SARS-CoV-2 infections (580,000/0.35%), which is 50.2% of the population of the U.S. (330 million).

    a Ioannidis, JPA. The infection fatality rate of COVID-19 inferred from seroprevalence data. Bulletin of the World Health Organization. 2020 Oct 14 [cited 2021 Apr 16]. https://www.who.int/bulletin/online_first/BLT.20.265892.pdf?ua=1.
    b Reese H, Iuliano AD, Patel NN, Garg S, Kim L, Silk BJ, Hall AJ, Fry A, Reed C. Estimated incidence of coronavirus disease 2019 (COVID-19) illness and hospitalization—United States, February–September 2020. Clin Infect Dis. 2020; Nov 25;ciaa1780. https://doi.org/10.1093/cid/ciaa1780.
    c Oran DP, Topol EJ. The proportion of SARS-CoV-2 infections that are asymptomatic: a systematic review. Ann Intern Med. 2021 May;174(5):655-62. https://doi.org/10.7326/M20-6976.
    d Worldometer. Coronavirus: United States. https://www.worldometers.info/coronavirus/country/us/.

Download Letter (PDF)

Enclosed:
Pfizer Bio-NTech COVID-19 Vaccine Risk Statement
Moderna COVID-19 Vaccine Risk Statement
Janssen (J&J) COVID-19 Vaccine Risk Statement