Pfizer and BioNTech now want their experimental COVID-19 vaccines to be approved by federal officials. But is it the right time for that?
As a significant portion of Americans is now fully vaccinated, Pfizer-BioNTech, on May 7, filed an application to the Food and Drug Administration (FDA) for approval of a Biologics License Application to produce its COVID-19 vaccine.
All the vaccines being distributed in the U.S. right now are authorized for emergency use only, including those of Pfizer-BioNTech, Moderna, and Janssen. This means that none of them can be considered ‘approved.’
Until now, Pfizer has already rolled out roughly 170 million doses to Americans and is expecting to reach a new target of 300 million injections by the end of July.
The FDA granted Pfizer the Emergency Use Authorization (EUA) last year as the U.S. was indisputably in an urgent state as the coronavirus was prevailing. The vaccine only required two months of trials to be passed. In comparison, the Biologics License Application (BLA) demands at least six months of study on no less than 3,000 participants to clarify the drug’s potential side effects.
Still, the FDA would authorize full approval if the study results proved that the effectiveness of the vaccines stays at 50% or more.
Dr. Peter Doshi, the editor of the British Medical Journal, was doubtful of the length of trials for FDA to approve BLA. He said that those of COVID-19 vaccines were authorized “the fastest” in the medical agency’s history, explaining that since 2006 vaccines for other diseases were usually screened through after 23 months of trials, nearly four times the trials for those that are being used to treat COVID-19.
“On paper, the phase III studies by Pfizer, Moderna and Janssen are all of two years’ duration,” the outlet noted.
CNBC said that the BLA approval would benefit lower prices and that the vaccines could still be found in drug stores when the pandemic subsides. Likewise, according to a professor of pediatrics at Tufts University and a member of the FDA’s advisory committee, Dr. Cody Meissner. It may serve as an encouragement to vaccine doubters who remain tentative of having a shot.
Plus, if the FDA no longer considers Pfizer’s vaccines experimental, Dr. Meissner surmised it would open a chance for vaccine mandate. This shall be bad news for vaccine hesitators who remain conscious of the potential effects the drugs may bring about.
“It is unlikely these vaccines will be mandated while an EUA (Emergency Use Authorization) is in place. Remember that currently these vaccines are still considered experimental,” the professor said.
Plus, when counting on the cases of severe side-effects that continue to amount up as more people get inoculated, the posibility of a vaccine mandate does not appear promising.
Vaccine Adverse Event Reporting System (VAERS) on May 21 reviewed that out of the 18,528 patients who suffered from adverse reactions after taking the doses, there were already 4,201 deaths from Dec. 14, 2020, to May 14, 2021.
The Disease Control and Prevention (CDC) suggested that the numbers by VAERS are not creditable proofs to dismiss the vaccines, giving that the system opens for public reports which may include non-professional confirmed data. However, such statistics are undeniable data that the undesiring effects such as blood clots in those vaccines are available.
It is known that the possibility of vaccine breakthrough infections in those of the COVID-19 vaccine is there. Vaccine breakthrough is a term to describe when an individual still tested positive for the virus even after they were fully vaccinated.
In an update in May 25, the CDC came clean with 10,262 reported breakthrough infections, in that the fatality rate was 2%, which spanned among elderly patients.