Tension over boosters rises as FDA regulators quit and publicly blast Biden’s plan

booster blast —

Top FDA regulators side with WHO on boosters, citing insufficient data.

Beth Mole

Words and symbols adorn a large outdoor sign.

Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland.

Two leading vaccine regulators who had previously announced their resignations from the Food and Drug Administration have now come out against the Biden administration’s plan to offer COVID-19 booster shots.

In a viewpoint article published in The Lancet on Monday, Marion Gruber, the outgoing director of the FDA’s Office of Vaccines Research and Review (OVRR), and Phil Krause, the outgoing deputy director of the OVRR, argue against the current booster plans.

“Currently available evidence does not show the need for widespread use of booster vaccination,” the pair, along with colleagues, conclude in the article. Even if there are benefits from boosters, the shots still carry risks, and any benefits “will not outweigh the benefits of providing initial protection to the unvaccinated,” they write.

Gruber and Krause penned the Lancet article with 16 international colleagues, including several high-ranking experts at the World Health Organization. Krause is listed as the first author of the article and a corresponding author.

The pair’s public opposition to boosters comes just weeks after they announced their resignations from the FDA. Their departures set for October 31 and November, respectively.

Anger and frustration

Their resignations at the end of August were reportedly sparked by frustration and anger over the Biden administration’s decision in mid-August to begin offering booster doses as soon as the week of September 20. According to FDA sources, Gruber, Krause and others at the agency felt the decision was premature and overstepped the FDA’s role in greenlighting the use of boosters. At the time, Politico described the situation at the FDA as a “potential mutiny.”

The Lancet article seems to confirm that internal strife at the agency. Rather than backing the Biden administration’s booster plan, Gruber and Krause aligned with the WHO, which has also denounced booster shots and called for a moratorium on their use until at least the end of the year.

One of the WHO coauthors on the Lancet article is Dr. Mike Ryan, executive director of the WHO’s Health Emergencies Programme. He has previously blasted plans for boosters, likening them to “hand[ing] out extra life jackets to people who already have life jackets while we’re leaving other people to drown.”

The Lancet article rehashes much of the WHO’s arguments against offering boosters right now. The biggest argument is the fact that data suggests COVID-19 vaccines are holding up against time and the delta coronavirus variant. The vaccines are still providing excellent protection against severe disease and death—the primary purpose of vaccines. The US Centers for Disease Control and Prevention published data largely supporting this point last Friday.

Ongoing debate

Though some evidence seems to suggest that protection from vaccines may be waning over time, it’s not yet clear if overall protection from severe disease and death will dive in the near future. As the authors of The Lancet article note, data on weakening vaccine effectiveness has been noisy. For instance, data out of Israel suggests that vaccine effectiveness against severe disease was lower among people vaccinated either in January or April compared with those vaccinated in February or March. Also, the people who have now been vaccinated the longest include those with compromised immune systems, making it harder to interpret if any dips in protection would be relevant to the whole population.

Meanwhile, as data on boosters is debatable, the current vaccine supply is finite, the authors of The Lancet article argue. Any doses going to vaccinated populations are doses that aren’t going to unvaccinated frontline workers and others in high-risk groups in low-income countries.

“Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations,” the authors write. And, they add, “if vaccines are deployed where they would do the most good, they could hasten the end of the pandemic by inhibiting further evolution of variants.”

Gruber, Krause, and the other authors are careful to mention that boosters may be needed at some point in the future—if protection wanes significantly and/or if more dangerous variants develop. However, the decision to boost should be made with strong data, which is currently lacking.

The position is only likely to create more tension this week in the run-up to the Biden administration’s planned rollout of boosters starting next Monday. The FDA is convening a public meeting of advisors this Friday to review data on booster shots of the Pfizer/BioNTech vaccine.

Read More

Written by 

Leave a Reply

Your email address will not be published. Required fields are marked *