קורונה בישראל: 1,316,317 מקרים מאומתים (841+ מחצות) | 17,873 פעילים | 380 במצב קשה (164 מונשמים) | 7,999 נפטרים | 735 מאומתים אתמול

More than 6.7 million booster shots have been administered in total, according to CDC data. The bulk of those have gone to seniors, while about 2.4 million have gone to adults ages 18-64.

Examples of workers who may get Pfizer-BioNTech booster[ 1 ] shots

First responders (e.g., healthcare workers, firefighters, police, congregate care staff)
Education staff (e.g., teachers, support staff, daycare workers)
Food and agriculture workers
Manufacturing workers
Corrections workers
U.S. Postal Service workers
Public transit workers
Grocery store workers

Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

Are the COVID-19 vaccines rigorously tested?
Yes. Clinical trials are evaluating investigational COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed by FDA to determine safety and effectiveness. These clinical trials are being conducted according to the rigorous standards set forth by the FDA.

For an EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine. An EUA request for a COVID-19 vaccine can be submitted to FDA based on a final analysis of a phase 3 clinical efficacy trial or an interim analysis of such trial, i.e., an analysis performed before the planned end of the trial once the data have met the pre-specified

The FDA considered the data that the vaccine manufacturer submitted, information presented at the VRBPAC meeting, and the committee’s discussion, and has determined that based on the totality of the available scientific evidence, a booster dose of Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19 and that the known and potential benefits of a booster dose outweigh the known and potential risks in the populations that the FDA is authorizing for
use.

unapproved uses of approved medical products

The differences between Food and Drug Administration (FDA) emergency use authorization (EUA) versus full approval for a vaccine mostly relate to the quantity of data from studies. Both processes by the FDA rely on data regarding a vaccine’s safety and effectiveness and require a conclusion that potential benefits outweigh any potential risks.

FDA officials have been reviewing data and inspecting manufacturing facilities — two key and time-consuming parts of the standard approval process.

In the Washington Post article, the FDA official described the differences between EUA and FDA approval chiefly as differences of scale rather than scrutiny, with the agency undertaking review of vast amounts of data.

In addition, part of the full approval process for the FDA is a determination that the vaccine can be produced safely and reliably in the makers’ manufacturing facilities.

Any EUA can be granted if the FDA concludes that the “known and potential benefits outweigh the known and potential risks” of a product such as a vaccine. FDA approval merely requires the same conclusion, but has more data backing the conclusion.

After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others

We will continue to analyze data submitted to the FDA pertaining to the use of booster doses of COVID-19 vaccines and we will make further decisions as appropriate based on the data