When FDA Considers Covid-19 Booster Injections, Expect Rough Roads

When-FDA-Considers-Covid-19-Booster-Injections-Expect-Rough-Roads

When advisors to the US FDA convened in December to discuss whether the agency should approve Pfizer’s Covid-19 vaccine, it was widely assumed that the response would be yes. However, the answer turned out to be no. That group of advisors is meeting again to discuss booster injections nine months later, and the situation has shifted dramatically.

It’s not going to be a walk in the park. It will be provided with conflicting evidence when this advisory group meets on Friday, some of which suggests the need for boosters, while other pieces of data indicate that there is no such requirement.

When FDA Considers Covid-19 Booster Injections This Week, Expect Rough Roads

The advisors will very certainly argue the very nature of Covid-19 boosters, whether or not they would function, and what they are intended to achieve in the first place as well as their effectiveness. To make things even more complicated, the booster debate has turned political and even a little bit nasty.

President Joe Biden revealed his administration’s plan to launch a booster program earlier this month, giving a precise timeframe for the week of September 20 as a starting point.

When FDA Considers Covid-19 Booster Injections, Expect Rough Roads

Scientists were outraged, claiming that the President should have remained silent on the matter until the FDA and the Centers for Disease Control and Prevention completed their investigations.

Two FDA vaccine specialists have declared their intention to quit the government, prompting suspicion that the President’s statement was the catalyst.

This past Monday, the two FDA employees, who are among the agency’s most eminent vaccine specialists, co-authored a paper in which they said that current evidence does not seem to support the necessity for booster vaccines for the general population.

It was a surprising decision, considering the fact that FDA staff members are often reluctant to speak publicly regarding medicine and vaccine applications. When it came to explaining the whole set of events that led up to Friday’s meeting, Schaffner, an immunologist at Vanderbilt University, struggled to find the appropriate phrase.

Is it really necessary to use boosters?

An august group of experts, officially known as the FDA’s Vaccines and Other Biological Products Expert Panel, will meet on Friday to discuss vaccines and similar biological products. The majority of them are university medical experts who advise the FDA as to whether or not new medicines and vaccines should be approved or not.

Typically, the agency will follow their recommendations. According to three independent studies released last week in the Centers for Disease Control and Prevention’s Mortality and Morbidity Weekly Report, we don’t need boosters.

All three trials came to the same conclusion: the two dosages performed an excellent job of preventing patients from being admitted to the hospital with Covid-19, even long into the summer months. Three studies were conducted: one looked at data from 13 counties and states, another analyzed data from nine states, and also the third examined data from 5 Veterans Administration medical facilities.

A study carried out in Qatar discovered that protection against hospitalization and mortality continues for at least six months following the second dosage of the vaccine.