FDA Is Yet To Announce Plans For Booster Doses

The food and drug administration is yet to announce if it will grant authorization to Pfizer and BioNTech COVID-19 vaccine’s booster shots, even though the advisory panel of the US Centers for Disease Control and Prevention ended their two-day meeting on the topic.

Normally, before the Centers for Disease Control and Prevention along with their advisory committee meeting to discuss issues of such immunization practices to grant their recommendations, the Food and Drug Administration announces their decision.

FDA Is Yet To Announce Plans For Booster Doses

The panel of the CDC is expected to vote on booster doses by Thursday. But recently there officially was announced that they will postpone this meeting as the FDA has not announced their decision yet.

On Friday, the Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration, rejected booster shots for US citizens 16 years and older. They unanimously promoted an alternate plan to administer booster doses to Americans above 65 and those with underlying health conditions as they are more prone to getting severely sick by COVID-19.

This recommendation was controversial as the Biden-led administration wanted to start administering booster shots to the general population as soon as this week. The director of CDC, and Dr. Anthony Fauci, The White House chief medical advisor.

Biden’s plan for booster doses was already endorsed in August by top health regulators of the country including Janet Woodcock, the FDA commissioner, Rochelle Walensky,

As the committee did not deliver a vote favoring this decision, the Biden administration was forced to change its plan, by limiting booster doses to certain groups of the population, said the director of the world health organization, Lawrence Gostin.

Gostin said that growing evidence suggests wearing off of vaccines effectiveness, but two vaccine doses are still strongly preventing severe sickness, hospitalizations, and deaths.

Dr. Bruce Farber, Northwell Health chief of infectious diseases, said that the committee was put in a very awkward position as the government already announced administering booster doses.

Many health experts and scientists of the country were critical of Biden’s plan. They said that the data available was not enough to authorize booster doses to 16 years and above population.

It is now up to the regulators of the FDA to decide if the recommendation of the advisory committee of the FDA should be accepted or not. Most likely the recommendation will be accepted, and it would be advised to expand the eligible population for booster shots.

A spokesperson of the FDA refused to further say anything on the timing of the decision by the agency.

There is still some time for the FDA. Until Thursday afternoon, the advisory group of the CDC is not expected to decide on the population eligible for the Pfizer booster shots. If the FDA wouldn’t decide by Thursday, the decision may be postponed, said a federal health official.

The advisers of the CDC went through numerous presentations during the meeting on Wednesday. They were about data supporting booster shot distribution, including a presentation from an executive of Pfizer Who explained how a booster shot was safe and increased levels of antibodies.

Moderna and Pfizer released their own data showing breakthrough coronavirus cases in fully vaccinated people. It was observed that these cases were very low for those who were recently vaccinated. They suggested that the vaccine’s protection against coronavirus wore off over time.

The chair of Johns Hopkins University’s molecular microbiology and immunology, Dr. Arturo Casadevall, supports booster shots for the general population. He said that administering a booster juice would reduce breakthrough infections, including the Delta variant.

Pfizer presented a study of Israel showing that a booster dose of COVID-19 vaccine administered six months after two primary doses restore 95% protection. Many experts still argue that third doses for the general population are not required at present.