As governments prepare to live with COVID-19, some are questioning the reliance on drug manufacturers to tailor vaccines to prevent future virus variants that could lead to infections. signs of stress, according to several sources close to the matter. with problem.
Some vaccine experts say government agencies should fund and help develop the new generation of COVID vaccines, and seek innovation from smaller developers, as they did to identify current vaccines.
“We’ve established a research infrastructure that can do this relatively quickly if we prime the pump and create the same kind of plan for a second-generation vaccine as we did for a second-generation vaccine.” with first-generation vaccines,” said Dr. Larry Corey, a virologist. is overseeing US government-backed COVID vaccine trials, told Reuters.
BioNTech and Pfizer (NYSE:), who developed the most widely used COVID vaccine in the West, recently clashed with the European Medicines Agency (EMA) over the best strategy to develop a new vaccine. against the Omicron variant, and whatever may follow, two sources familiar with the matter told Reuters.
An EMA spokesperson said the agency, along with other regulators, is encouraging companies to explore vaccines that target multiple variants.
In January, BioNTech and Pfizer began testing a vaccine designed to specifically target Omicron, believing the best approach would be to tackle one major new variant at a time.
They have said a modified vaccine may not be needed even if the emergence of highly mutant Omicron late last year led to a record increase in infections.
EMA regulators have pressed drugmakers to give equal preference to a vaccine that targets multiple variants, arguing that it would provide broader protection against the diseases. future mutations, the sources said. One of the sources said the EMA would not signal whether current vaccine trials are sufficient to warrant approval even if the companies demonstrate safety and an immune response.
On Wednesday, BioNTech said the companies would expand their testing to test a single shot aimed at Omicron and the original version of the coronavirus.
BioNTech said it decided to test a combination shot to scientifically confirm decisions about the best vaccine strategy for the foreseeable future.
A BioNTech spokesperson declined to comment on the company’s discussions with EMA. A Pfizer spokesperson did not respond to a request for comment.
Moderna (NASDAQ:) Inc, which has also enjoyed great success with its COVID vaccine, is testing an injection that targets Omicron and the original coronavirus, aiming to be available in the fall.
Moderna lead scientist Jacqueline Miller said at a company event this month: “We believe this could lead to the broadest possible protection.
GlaxoSmithKline (NYSE:) is also working with German biotech CureVac on a vaccine that targets multiple coronavirus variants.
‘WE NEED TO DO BETTER’
European and US public health officials are pushing for better tools to fight COVID. Current vaccines are very effective against illness and death, but are no longer able to fight transmission, and immunity tends to wane within months.
Some health officials question whether companies that have raked in tens of billions of dollars from first-generation COVID shots and made billions more from repeat boosters are willing to spend the money to Figuring out whether a vaccine provides broader and longer-lasting protection could take years.
Pfizer and BioNTech say their decisions are guided by scientific findings.
Corey, from Seattle’s Fred Hutchinson Cancer Center, says any new and innovative approach could come from smaller companies that need to fund early development work.
“We need to do better, and we need to fund that,” Corey said, adding that a new generation of COVID vaccine could be backed by about $2 billion in funding. aid. The European Union has bet big on future Pfizer/BioNTech hits in a deal worth up to 35 billion euros ($39.04 billion). That agreement required drugmakers to modify their injections to deal with new variants.
EU member states have also expressed interest in footage targeting multiple variants. “The message they send to companies is ‘give us more options’,” said one of the sources familiar with the matter. The International Coalition for Epidemic Preparedness Innovations, which helped fund early studies on several existing vaccines, has $200 million available for world vaccine research. next system. It has awarded small grants to manufacturers including UK’s DIOSynVax and Israel’s MigVax.
Of the major Western COVID vaccine manufacturers, Pfizer and BioNTech appear farthest in redesigning their injections.
At the end of January, they launched a clinical trial testing the immune response to a vaccine that targets Omicron in unvaccinated people and as a booster in people who have been vaccinated. fully vaccinated. Results are expected in April.
BioNTech has argued that laboratory analyzes by other researchers show that exposure to Omicrons in previously immunized individuals leads to an extensive immune response against previous major coronavirus variants. , sources said.
Lab tests of a previous BioNTech/Pfizer shot targeting the Alpha and Delta variants, they added, yielded a poorer immune response than what would be expected from a single vaccine. variant.
GSK said combination vaccines can pose other difficulties, including exacerbation of temporary side effects when given current vaccines. Cutting the dosage to avoid that could affect effectiveness, but GSK says it’s working on that.
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