by Franco Lodige
The news, stark and raw, is this: the American regulator for vaccines, the Food and Drug Administration, should soon authorize a new round of boosters against Covid-19. The problem, explains The Wall Street Journal, is that there would be “no data from a study showing whether injections are safe and working.” Translated: a little to the he wished well.
According to the US newspaper, in fact, the FDA will make its own decisions regarding vaccines against the latest Omicron sub-variants when the manufacturing companies have not yet completed the tests on humans. The aim would be to use data from research on mice, from studies on the original product or from the effects of the vaccination campaign already in place. “Real-world evidence of current AD vaccines mRNA per Covid-19which have been administered to millions of people, show us that vaccines are safe, ”FDA commissioner Robert Califf wrote in a recent tweet.
Can the FDA authorize a vaccine without first reading the human test data? It happens, the WSJ said, also for the anti-flu vaccines that are updated year after year to keep up with the mutations of the flu viruses. The question, however, at this point is legitimate: having changed the reference technology, are we sure that the same approach is fine? “I’m uncomfortable for the fact that we would give millions or tens of millions of doses to people based on the data on mice“Said Paul Offit, FDAE consultant director of Vaccine Education Center at the Children’s Hospital of Philadelphia.
Until now, the Americans have only received the “original” vaccines, as have the Italians. Ahead of the fall, the US federal government had asked both Pfizer and Moderna to update their products to both Omicron and its sub-variant, as well as the original strain of course. According to the two companies, which meanwhile have started a legal war for patents, the data proving them that the vaccines are safe and effective. According to what the WSJ writes, the tests of the “new” vaccines on humans are about to be carried out: Moderna has already started, Pfizer will soon. However, and this is the decisive point, the results will not be available before the start of the autumn recall campaign already planned by Biden & co. “If we waited for the results of the clinical trial we would have them in the spring. It takes time to do clinical trials, ”said William Schaffner, a professor of medicine at Vanderbilt University Medical Center. “This is just an update of the previous vaccine we used.”
It must be said that both Pfizer and Moderna have made vaccine tests that were supposed to fight the first version of Omicron (not its current sub-variants). The FDA had also examined them. “The results – explains the WSJ – give the FDA the certainty that even the new modified vaccines will work well”. “As we know from previous experience, it is possible to make changes to the strain without compromising its safety,” added Dr. Califf in a tweet. But not everyone agrees.
Franco Lodige, August 29, 2022