President Joe Biden said that he would follow the science regarding the coronavirus policy, but according to two Food and Drug Administration (FDA) officials, there is political pressure to push for coronavirus booster shots.
The two top FDA vaccine regulators, Marion Gruber and Philip Krause recently resigned from the agency over what they saw as "uncomfortable similarities between the Biden team’s top-down booster plan and former President Donald Trump’s attempts to goad FDA into accelerating its initial authorization process for Covid-19 vaccines and push through unproven virus treatments."
Before he was inaugurated, President Biden unveiled his team of scientific advisers and promising to help restore the faith of Americans in science and discovery. During his inauguration, he also said that he will allow his administration to be guided by the best science.
"The Federal Government must be guided by the best science and be protected by processes that ensure the integrity of Federal decision-making. It is, therefore, the policy of my Administration to listen to the science," the president said.
According to officials in the FDA, however, Biden's approach to science was more political. As many as 11 current and former FDA officials said that they have grown frustrated over the administration's process regarding booster shots.
In August, the U.S. Health and Human Services released a joint statement with medical health officials, announcing the release of the COVID-19 booster shots by September 20, but health officials noted that political appointees within the White House steered the statement instead of the FDA.
The FDA officials also met with confusion Biden's abrupt shift from suggesting that boosters be recommended eight months after the first shots, to five months after. This suggestion allegedly came after he met with Israeli Prime Minister Naftali Bennett.
Despite the resignations, however, acting FDA Commissioner Janet Woodcock sent a memo expressing support for the current process, citing complexity issues over the matter. (Related: Even the WHO says booster shots are unnecessary, but Biden's White House prefers to listen to Big Pharma: BOOSTER covid shots coming to the USA.)
Biden's oppressive booster plan facing FDA resistance
Pfizer Inc. and BioNTech SE, filed for authorization for the last extra COVID-19 shot last month. Some short-term data from Israel supports the use of the booster shots, but the public push by the White House to roll out the boosters has raised concerns, with many believing that the administration is rushing ahead without enough data and regulatory oversight.
Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia and a former member of the CDC’s advisory panel of outside experts that evaluates vaccine data for the agency, said that he would be very surprised if the CDC recommends a third dose of the vaccine to the general population.
The committee was said to have planned for the evaluation of the boosters at an August 24 meeting that was postponed, and then delayed to the middle of September. Instead of the expected vote on the shots, CDC's Sara Oliver set out guidelines for considering boosters, pushing that the current vaccine regimens are safe and that they prevent deaths and hospitalizations.
The original plan is for people to get boosters eight months after their second shot of either Pfizer or Moderna vaccine. This would put older people and health workers first in line.
The policy for booster doses should take into account the benefit and risk balance, said Oliver. It is critical to wait for additional safety data and regulatory allowance before pushing through with booster doses.
With the delta strain ravaging the U.S., the booster shots are seen as a potential key in controlling the surge. Still, debates regarding the need for, and the effectiveness of the boosters are ongoing. Booster advocates said that breakthrough infections among the vaccinated show that standard regimens are not enough to stop the spread of the delta variant.
The vaccine panel is still waiting for more data to determine the best approach for booster doses.
Find more updates about the COVID-19 vaccine at Pandemic.news.
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