Pfizer new Covid-19 vaccine provides 95% protection with a booster shot. The company submitted the following statistics to the Food and Drug Administration (FDA) regarding Israeli vaccination cases.
The FDA reported on the 15th (local time) that this finding came from the Israeli booster shot that Pfizer submitted to them.
In Israel, the third vaccination enhanced protection against Covid-19 by 95% six months after the second.
Messenger RNA (mRNA) vaccines developed by Pfizer and Moderna have the downside that the immune response wanes over time.
Pfizer said in a 52-page report submitted to the FDA the same day that booster shots produce a similar response to that of the second dose.
Data from the BoosterShot vaccination program for Israel’s entire population showed that the third dose was able to prevent the occurrence of Covid-19 to a very high level, rated as providing about 95% protection.
In Israel, delta mutations were spreading rapidly between July 1 and August 30.
Yet, the FDA has not yet ruled on booster injections. In a 23-page report released this afternoon, the FDA said no valid evidence supports the need for booster injections.
The FDA said that it was reviewing other studies “possibly relevant” to its review of the immunity of the Pfizer vaccine, but noted that these studies produced mixed results. Further, the report explained that the data are also confusing, with some being more reliable than others.
According to the FDA, the Israeli data submitted by Pfizer are observational studies and cannot be considered completely reliable since they are not held to the same rigorous standards as a formal clinical trial.
“Observational studies help us understand how well they work in the real world, but there are known and unknown biases that can affect their reliability,” the FDA stated in its report. Thus, some studies may or may not be more reliable than others.”
A Pfizer report is scheduled to be submitted to the FDA’s Vaccines and Related Biologics Advisory Committee (VRBPAC) on the 17th. VRBPAC will vote on whether Pfizer can recall vaccines to the public on the 17th.
In the U.S., Pfizer has submitted a request for approval to administer the BoosterShot dose six months after the second dose.