FDA Overwhelmingly Rejects Bidens Covid Booster Shot Plan

A government advisory panel rejected Friday’s plan to give Pfizer COVID-19 boost shots to all of its employees. Instead, it endorsed the additional vaccine dose for people who are 65 years or older and at high risk of serious disease.

The twin votes were a blow to the Biden administration’s massive effort to protect nearly all Americans from the deadly delta variant, which was announced one month ago.

An influential committee of experts outside the Food and Drug Administration ruled in favor.

Surprisingly, the panel voted 16-2 against boosters for nearly everyone. Members raised concerns about safety data regarding extra doses. They also raised questions about mass boosters’ value, as opposed to those that are targeted at specific groups.

It then endorsed an additional shot for selected portions of the U.S. populace, namely those most at-risk from the virus, with an 18-0 vote.

This would save a portion of the White House campaign, but it would still be a big step back from the proposal to offer booster shots for both Moderna and Pfizer vaccines to Americans eighteen months after receiving their second dose.

Friday’s ruling was only the first step of the process. Although the FDA is expected to decide on boosters within the next few days it will usually follow the recommendations of the committee.

The Centers for Disease Control and Prevention will also review the offer of boosters. The question will be referred to the CDC advisory panel on Wednesday. The CDC stated that it is looking at boosters for seniors, residents of nursing homes, and front-line health care workers rather than all adults.

Most likely, the FDA and CDC will decide at a later date whether or not people who have received J&J or Moderna shots should receive boosters.

Friday’s heated debate saw members of the panel question the wisdom of offering boosters for almost everyone 16 years and older.

“I don’t think a booster dose is going to significantly contribute to controlling the pandemic,” said Dr. Cody Meissner of Tufts University. “And I think it’s important that the main message we transmit is that we’ve got to get everyone two doses.”

Dr. Amanda Cohn of the CDC stated: “At this moment it is clear that the unvaccinated are driving transmission in the United States.”
Scientists inside and outside the government have been divided recently over the need for boosters and who should get them, and the World Health Organization has strongly objected to rich nations giving a third round of shots when poor countries don’t have enough vaccine for their first.

While research suggests immunity levels in those who have been vaccinated wane over time and boosters can reverse that, the Pfizer vaccine is still highly protective against severe illness and death, even amid the delta variant.

This unexpected turn in events could strengthen recent criticisms that the Biden administration pushed for boosters way ahead of science. After revelations of political meddling in Trump’s coronavirus response, President Joe Biden said that his administration would “follow the science.”

The FDA panel rejected the FDA panel’s initial rejection in overwhelming detail despite the full-throated arguments from Pfizer and Israeli health officials about the need to provide boosters. Israel began providing boosters to its citizens in July.

Sharon Alroy-Preis of Israel’s Ministry of Health said the booster dose improves protection tenfold against infection in people 60 and older.

“It’s like a fresh vaccine,” bringing protection back to original levels and helping Israel “dampen severe cases in the fourth wave,” she stated.

Representatives from Pfizer said that it was important to strengthen immunity before the protection begins to diminish. An independent study found that 96% of patients with symptomatic COVID-19 were effective after two months, but this dropped to 84% within six months.

Panelists reacted negatively to both Pfizer’s and Israeli representatives. Many panelists were skeptical of the value of Israel’s experience for the U.S. Others were concerned about whether third doses might exacerbate severe side effects, such as rare cases of heart inflammation in younger men.

Pfizer pointed to Israeli data from nearly 3 million boosters to suggest side effect rates would be similar to those already reported.

Dr.Offit stated that while an additional shot might reduce mild to no symptoms at all, it would not have a significant impact on the pandemic.

While an extra shot would probably at least temporarily reduce cases with mild or no symptoms, “the question becomes what will be the impact of that on the arc of the pandemic, which may not be all that much,” Offit stated.

Biden’s top health advisors, which included the FDA and CDC heads, announced plans to distribute booster shots widely in mid-August. They set the week of September 20 as the most likely start date. However, this was before FDA scientists had done their own assessment of the data.

Earlier this week, two top FDA vaccine reviewers joined a group of international scientists in publishing an editorial rejecting the need for boosters in healthy people. The scientists said studies show the shots are working well.

On Friday, U.S. Surgeon General Dr. Vivek Murthy said that the Biden administration announcement was not aimed at pressuring regulators to act but was instead an attempt to be transparent with the public and be prepared in the event that boosters won approval.

“We have always said that this initial plan would be contingent on the FDA and the CDC’s independent evaluation,” Murthy stated.

There are major ethical concerns regarding the Biden plan, which raises concern about poorer parts of the globe still seeking vaccines. The administration countered that the plan was not an “us-or-them” choice. They pointed out that large amounts of vaccines are being supplied by the U.S. to the rest of the world.

Pfizer and Moderna boosters have been approved by the U.S. for certain individuals with weak immune systems such as transplant recipients and cancer patients.

Many Americans, whether they are healthy or not have been able to get boosters. In some cases, all it took was showing up and asking for a shot. Some health systems offer extra doses for high-risk patients.