Health regulators must decide by the end of the month whether to approve Covid-19 vaccines targeting the latest virus strains without first requiring clinical data, BioNTech’s chief executive said, as studies show that injections developed more early in the pandemic, are less effective against the latest options.
Ugur Shahin warned that a sub-variant of Omicron could emerge that completely avoids vaccine protection as countries prepare to launch autumn boost campaigns. The debate over whether to allow a faster transition to an updated vaccine is becoming more “urgent”, he said in an interview with FT.
A number of studies – including one of BioNTech and another in the scientific journal Nature, both published this month, show that previous infections with the original Omicron strain, known as BA.1, do not provide a strong antibody response to newer versions. This suggests that vaccines under development to address BA.1 may not offer the best protection.
“The weather is ticking,” Sahin said. Even photos using fast mRNA technology, such as BioNTech and Moderna, could take three months from strain selection to mass production of vaccines, he said. If new clinical data are needed, this may take four months longer.
“It would be useful to be able to adapt the vaccine to the latest data without requiring additional clinical trials,” he said. Şahin added that the safety data will not differ from the original vaccine and Omicron-compliant trials, as they will simply “change a number of amino acids in the thorn protein”.
The call from the head of BioNTech comes when the US Food and Drug Administration said it was talking to manufacturers to look for vaccines for the rapidly spreading sub-options BA.4 and BA.5, which caused a jump in Admission to Covid-19 Hospital throughout Europe. Peter Marx, director of the FDA’s Center for Biological Substance Evaluation and Research, said the regulator was examining “all the tools in our toolbox” to ensure that the autumn booster was closely matched to the dominant strain at the time.
“It will be very important to be as close as possible to what is circulating as we move through the coming months,” he said.
Global regulators will meet later this month to discuss switching to new Omicron-adapted vaccines as they prepare for autumn booster campaigns designed to protect the elderly and the most vulnerable to the next wave of Covid-19. .
Vaccine manufacturers this month began publishing data from clinical trials of vaccines targeting BA.1. Initial data show that Moderna’s two-strain vaccine has worked better to deal with the dominant version of Omicron than its predecessor, and the beta-vaccine Sanofi and GSK vaccine is more effective than its previous candidate. dealing with Omicron. BioNTech and Pfizer began sending their unpublished data to regulators this week.
An international coalition of drug regulators will meet to discuss the data later this month. The FDA will also hold its advisory meeting in late June, but will not decide whether to make the change by July. Marx said last month that a new vaccine would have to be at least 10 percent better at fighting new strains than the current version.
Marco Cavaleri, head of vaccines at the European Medicines Agency, said regulators need to know if the new tailor-made injections are superior to their predecessors and how many doses will be available before countries decide who should get another booster in the fall.
“This global conversation is extremely important because we believe that global alignment is very important,” he said in an interview.
Amesh Adalja, a senior scientist at Johns Hopkins University in the United States, said it would be better for manufacturers if switching was coordinated around the world because they could change their entire production at once.
“I don’t think there is an advantage in not synchronizing logistics,” he said.
The World Health Organization has supported the use of a targeted shot by Omicron third dose to enhance immune responses. However, Sumya Swaminathan, a leading scientist at the WHO, said she was waiting for more evidence comparing the adapted vaccines with the original vaccines. Based on data from existing vaccines, she is not convinced that the fourth dose makes a significant difference to most people, she said.
“While short-term follow-up studies have shown the benefit of the fourth dose in reducing symptomatic infection, this effect does not seem to last long,” she said, adding that three doses were enough to provide long-term protection against serious illness. .
But while regulators are looking closely at data from tests launched several months ago, Shahin suggested there needs to be a more flexible system, such as the one used to select the next strains for the annual flu vaccine, before clinical data become available. Each year, the WHO recommends strains of influenza virus that should be used in an updated vaccine.
A new system will allow vaccine manufacturers to continue to develop a vaccine targeting BA.4 and BA.5 and change course if a new option emerges in the summer. BioNTech also used AI to try to predict the most likely new mutations before they happen, Shahin said.
Additional reports from Sarah Neville in London, Silke Richter in Berlin and James Schoter in Tel Aviv