COVID-19 vaccine boosters not most needed, say top FDA and WHO scientists

The medical journal argues that governments would be better served to focus on non-vaccination and wait for more data on boosters, and which doses will be most effective, the authors, including two leading US Food and Drug Administration experts. were involved, argued in the medical journal. the Lancet. They based their assessment on data from a wide range of real-world observational studies as well as clinical trials.

“No study has provided reliable evidence of a substantial reduction in protection against serious disease,” the authors wrote. There may also be additional side-effects risks if boosters are introduced too soon or too widely.

The review comes as most countries have adequate vaccine supplies debate whether to allocate doses for booster shots to boost immunity and potentially help prevent the spread of the more infectious delta variant. The US plans to introduce booster shots starting September 20, though the plan still requires sign-off from the FDA and the Centers for Disease Control and Prevention.

Scientists are by no means unanimous on the subject of boosters. Even a small decrease in efficacy against the spread of COVID can overwhelm a healthcare system, and “therefore there is no ‘one size fits all’ approach,” says Imperial College said Azra Ghani, the chair of infectious disease epidemiology in London, who was not involved in the review.

A UK government advisory panel is set to make recommendations soon whether to proceed with the widespread use of a third vaccine dose. The UK is already offering boosters to people with severely weakened immune systems, as are many EU countries. The European Medicines Agency is also reviewing booster data from the Pfizer Inc.-BioNTech SE partnership and Moderna Inc.

what saves lives

Among the scientists behind the Lancet article were Marion Gruber, who leads the FDA’s Office of Vaccines Research and Review, and her deputy, Philip Krauss. Both have said they will step down at the end of this year. According to a person familiar with the matter, Gruber and Krause were two of a group of FDA employees who pushed back last year against pressure from the Trump administration to accelerate authorization of COVID vaccines.

Soumya Swaminathan, Ana-Maria Henao-Restrepo and Mike Ryan of the World Health Organization also worked on the review. The WHO has pushed against the widespread use of boosters, saying it makes better public-health sense to focus on vaccinating people who haven’t had a shot yet – regardless of countries with adequate reserves. because of anti-vaccine sentiment, or because they live in places with little access to shots.

The authors wrote, “Even if boosting was ultimately shown to reduce the medium-term risk of severe disease, the current vaccine supply could save more lives than if used in a previously unvaccinated population.” Goes.”

The review found that in the observational studies conducted so far, vaccination has been, on average, 95% effective against serious disease, including more infectious forms such as Delta, and more than 80% effective in preventing any infection. The study found that even in countries with high vaccination rates, it is the non-vaccinated people who are driving the transmission of the virus – and who are at the highest risk of getting very sick.