Meeting of FDA advisers could decide booster debate

WASHINGTON • US President Joe Biden's push to offer third doses of Pfizer's coronavirus vaccine faced the first of two crucial tests when advisers to the Food and Drug Administration (FDA) discussed yesterday whether booster shots should be offered to most Americans.

The meeting took place as an extraordinary public debate plays out among administration officials, pharmaceutical executives, scientists and public health experts over whether boosters are needed, and whether they would do more good being sent to poorer nations whose residents have not received even a single shot.

The White House's plan to begin offering boosters to almost all vaccinated adults starting next week has raised concerns among health experts that the administration is rushing ahead without enough data and regulatory oversight.

The announcement came without the FDA and Centres for Disease Control and Prevention publicly saying they had fully vetted giving a third shot to the 180 million fully vaccinated Americans.

"If the advisory committee votes not to support boosters, this will put the administration in an awkward position," said Mr Norman Baylor, former director of the FDA's Office of Vaccines Research and Review and now chief executive of Biologics Consulting.

The agency is not obligated to follow the recommendations of the advisory panel, called the Vaccines and Related Biological Products Advisory Committee, though it typically does.

Pfizer and its partner BioNTech were expected to present data at the meeting suggesting that the efficacy of their Covid-19 vaccine wanes over time, and that a booster dose is safe and effective at warding off new variants.

New data from Israel supports that premise. A third dose of the Pfizer vaccine can dramatically reduce rates of Covid-related illness in people aged 60 and above, according to a study in Israel released on Wednesday by the New England Journal of Medicine.

But some scientists and even two top FDA officials have questioned evidence supporting the need for a third dose. Covid-19 vaccines work well and governments would be better served to focus on immunising the unvaccinated, according to a review authored by an all-star panel of scientists from around the world and published last Monday in The Lancet.

The second test for the Biden administration comes next week. A panel of outside experts who advise the CDC on how best to administer new vaccines will meet from Sept 22 to 23.

The outcome of the booster decisions is critical for Pfizer, as it will shape the long-term marketplace for what has become the world's biggest-selling drug.

Pfizer said in July that it expects its vaccine to generate US$33.5 billion (S$45 billion) in revenue this year, putting it on course to become one of the best-selling medicines of all time.

The same goes for Moderna, whose vaccine uses similar mRNA technology. Moderna joined the S&P 500 earlier this year when its value nearly tripled. The biotech company is also seeking clearance for a booster dose.

"A third shot is likely, both for Pfizer and Moderna vaccination, and that should continue to support very high sales we would project through 2023," said Mr Damien Conover, senior equity analyst at Morningstar.

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