Kennedy issues demands for vaccine approvals that could affect Covid-19 boosters in US
Sign up now: Get ST's newsletters delivered to your inbox
US Health Secretary Robert F. Kennedy Jr says the new policy will not affect flu shots, but the future of Covid-19 boosters is now in doubt.
PHOTO: REUTERS
Christina Jewett and Sheryl Gay Stolberg
WASHINGTON – US Health Secretary Robert F. Kennedy Jr on May 1 announced plans to require all new vaccines to be tested against placebos and to develop new vaccines without using mRNA technology, moves that extend his reach deep into vaccine development and raise questions about whether Covid-19 boosters will be available in the autumn in the US.
A spokesperson for the US Department of Health and Human Services called the requirement for placebo testing “a radical departure” from existing standards.
But that will depend on how the department defines “new”, because most new vaccines are already tested either against placebos – inert substances – or, in some cases, against vaccines for other diseases.
Mr Kennedy is one of the US’ leading vaccine sceptics, and he has been vocal about his disdain for mRNA technology, which was used to develop coronavirus vaccines during the first Trump administration.
His announcements on May 1 represent an extraordinary use of his power as secretary to make decisions ordinarily left to career scientists at the Food and Drug Administration.
Most immediately, Mr Kennedy’s move could affect the next round of Covid-19 booster shots.
Both flu shots and Covid-19 boosters have been authorised without extensive human trials to target new strains of the virus as it has evolved.
Mr Kennedy says the new policy will not affect flu shots, but the future of Covid-19 boosters is now in doubt.
Mr Andrew Nixon, the department spokesman, said that because so many people have been infected and now have immunity to Covid-19, new studies are required.
“As we’ve said before, trials from four years ago conducted in people without natural immunity no longer suffice,” he said. “A four-year-old trial is also not a blank cheque for new vaccines each year without clinical trial data.”
Mr Kennedy’s plan for the placebo studies, first reported by The Washington Post, also raises ethical questions. It is considered unethical to deprive even a small group of patients of effective vaccines against deadly pathogens.
In the case of Covid-19, new clinical studies could hold up authorisation for boosters, which would leave the entire US population vulnerable.
The US Centres for Disease Control and Prevention reported about 23,000 deaths from Covid-19 since September, with as many as 1,000 a week that month and in January. NYTIMES
