Federal Register - June 21, 2021
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Federal Register / Vol. 86, No. 116 / Monday, June 21, 2021 / Rules and Regulations
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c. The Effect of Vaccines on the Grave Danger Presented by SARSCoV2
The development of safe and highly effective vaccines and the on-going nation-wide distribution of these vaccines are encouraging milestones in the nations response to COVID19.
Although there was initial uncertainty attached to the performance of authorized vaccines outside of clinical trials, vaccines have been in use for several months and they have proven effective in reducing transmission as well as the severity of COVID19 cases.
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Data now available clearly establish that fully-vaccinated persons defined as two weeks after the second dose of the mRNA vaccines or two weeks after the single dose vaccine have a greatly reduced risk compared to unvaccinated individuals. This includes reductions in deaths, severe infections requiring hospitalization, and less severe symptomatic infections. The combination of data from clinical trials and data from mass vaccination efforts points increasingly to a significantly lower risk in settings where all workers are fully vaccinated and are not providing direct care for individuals with suspected or confirmed COVID19.
OSHA has therefore determined that there is insufficient evidence in the record to support a grave danger finding for employees in non-healthcare workplaces or discrete segments of workplaces where all employees are vaccinated. However, in healthcare settings where workers are vaccinated, as discussed below, the best available evidence establishes a grave danger still exists, given the greater potential for breakthrough cases in light of the greater frequency of exposure to suspected and confirmed COVID19 patients in those settings Birhane et al., May 28, 2021.
In addition, the best available evidence shows that vaccination has not eliminated the grave danger in mixed healthcare workplaces i.e., those where some workers are fully vaccinated and some are unvaccinated or in those healthcare workplaces where no one has yet been vaccinated.
The Effectiveness of Authorized Vaccines There are currently three vaccines for the prevention of COVID19 that have received EUAs from the FDA, allowing for their distribution in the U.S.: The Pfizer-BioNTech COVID19 vaccine, the Moderna COVID19 vaccine, and the Janssen COVID19 vaccine. PfizerBioNTech and Moderna are mRNA
vaccines that require two doses administered three weeks and one month apart, respectively. Janssen is a viral vector vaccine that requires a single dose CDC, April 2, 2021. The vaccines were shown to greatly exceed minimum efficacy standards in preventing COVID19 in clinical trial participants FDA, December 11, 2020;
FDA, December 18, 2020; FDA, February 26, 2021. Data from clinical trials for all three vaccines and observational studies for the two mRNA
vaccines clearly establish that fully vaccinated persons have a greatly reduced risk of SARSCoV2 infection compared to unvaccinated individuals.
This includes severe infections
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