Companies like Pfizer and BioNTech submitted data to the FDA showing proof for another dose of the COVID-19 vaccine. Photo courtesy of Pixabay.com.
Zoë Hill | News Editor
Health officials are expected to recommended COVID-19 vaccine booster shots administered eight months after initial doses for all Americans.
As the vaccines work to receive full approval from the Food and Drug Administration (FDA), Pfizer and BioNTech want the green light for a booster shot. The companies submitted Phase 1 data to the FDA showing the need for another dose of the vaccine.
“The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule,” said Albert Bourla, Chairman and Chief Executive Officer of Pfizer. “We are pleased to submit these data to the FDA as we continue working together to address the evolving challenges of this pandemic.”
Bourla initially suggested the need for a booster shot earlier this year, but the Centers for Disease Control and Prevention and the FDA decided against the recommendation in July, saying that it was unnecessary given the available data.
The FDA moved to approve a booster shot for severely immunocompromised individuals under Emergency Use Authorization on Thursday. Acting FDA Commissioner Dr. Janet Woodcock said in a statement that these individuals are at a specifically higher risk of severe infection during the ongoing fourth wave of the coronavirus.
“After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” Woodcock said.
Four people close to the matter spoke anonymously with The Washington Post, revealing that all Americans, regardless of age or health, need a booster dose of the vaccine. The official announcement from health officials and the Biden Administration could come as early as this week.
There is no official timeline for the roll-out of the third dose, but health officials expect administration beginning in mid- or late September after the FDA gives the go-ahead. The program would likely mirror the initial vaccine roll-out, placing health care workers, immunocompromised individuals and the elderly first in line.
The Biden Administration has stockpiled at least 100 million doses, the New York Times reported. The World Health Organization (WHO) believes extra doses can be better used in areas where populations have yet to receive their first and second doses.
“In the context of ongoing global vaccine supply constraints, administration of booster doses will exacerbate inequities by driving up demand and consuming scarce supply while priority populations in some countries, or subnational settings, have not yet received a primary vaccination series,” WHO said in an interim statement.
Nearly 169 million Americans are fully vaccinated and would be eligible for a third dose when the Biden Administration and FDA announce the booster shot plan. The total falls just over a majority of the U.S.’s eligible population. Globally, the U.S. ranks 31st for the percentage of the population fully vaccinated, according to CDC data. The least vaccinated populations come out of Africa, where much of the continent is unvaccinated.
“We continuously strive to stay at least one step ahead of the virus. This is why we aim to expand access to our vaccine for people around the world and are working on various approaches as part of our comprehensive strategy to address the virus and its variants today as well as in the future,” said Dr. Ugur Sahin, CEO and Co-founder of BioNTech.