As governments prepare to live with COVID-19, some are questioning how much to rely on drugmakers to adapt vaccines to ward off future virus variants amid signs of tension between companies and regulators over the best approach, according to several sources familiar with the matter.
Some vaccine experts say government agencies should fund and help develop a new generation of COVID shots, and seek innovation from smaller developers, as they did to identify current vaccines.
"We have established a research infrastructure that could do this relatively reasonably rapidly if we primed the pump and created the same kind of plan for second-generation vaccines as we did for the first-generation vaccines," Dr. Larry Corey, a virologist who is overseeing U.S. government-backed COVID vaccine trials, told Reuters.
BioNTech and Pfizer, who developed the western world's most widely used COVID vaccine, recently clashed with the European Medicines Agency (EMA) over the best strategy for developing 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, are encouraging companies to explore vaccines that target multiple variants.
In January, BioNTech and Pfizer began testing a vaccine designed to target Omicron alone, believing the best approach is to tackle one major new variant at a time.
They had said a modified vaccine may not be necessary even after emergence of the highly-mutated Omicron late last year led to a record surge in infections.
EMA regulators pressed the drugmakers to give equal priority to a vaccine targeting multiple variants, figuring that would offer broader protection against future mutations, the sources said. One of the sources said EMA would not signal whether the current vaccine trials will be enough to warrant approval even if the companies demonstrate safety and immune response.
On Wednesday, BioNTech said the companies would broaden their trial to test a shot targeting Omicron and the original version of the coronavirus.
BioNTech said it decided to test a combination shot to scientifically validate decisions on the best vaccine strategy for the near future.
A BioNTech spokesperson declined to comment on the company's discussions with EMA. A Pfizer spokesperson did not respond to requests for comment.
Moderna Inc, which has also enjoyed great success with its COVID vaccine, is testing a shot that targets Omicron and the original coronavirus, aiming to have it ready in the fall.
"We believe this may lead to the best breadth in protection," top Moderna scientist Jacqueline Miller said at a company event this month.
GlaxoSmithKline is also working with German biotech CureVac on a vaccine that targets multiple coronavirus variants.
'WE NEED TO DO BETTER'
European and U.S. public health officials are pushing for better tools to fight COVID. Current vaccines are very effective against severe disease and death, but no longer against transmission, and immunity levels tend to wane within months.
Some health officials question whether companies that have reaped tens of billions of dollars from first-generation COVID shots and stand to earn billions more from repeated boosters are willing to spend the money to find vaccines offering much broader and longer-lasting protection, which could take years.
Pfizer and BioNTech say their decisions are led by scientific findings.
Any new and innovative approach may come from smaller companies that will need funding for early development work, said Corey, from Seattle's Fred Hutchinson Cancer Center.
"We need to do better, and we need to fund that," Corey said, adding that a new generation of COVID vaccines could be supported by about $2 billion in funding. The European Union made a massive bet on future Pfizer/ BioNTech shots in a deal worth up to 35 billion euros ($39.04 billion). That agreement requires the drugmakers to revise their shots to deal with new variants.
EU member states have also expressed interest in shots targeting multiple variants. "The message they've sent to the companies is 'give us more options,'" one of the sources familiar with the matter said. The international Coalition for Epidemic Preparedness Innovations, which helped fund early research into some existing vaccines, has $200 million available for next-generation vaccine research. It has awarded small grants to manufacturers including the UK's DIOSynVax and MigVax of Israel.
Among the major Western COVID vaccine makers, Pfizer and BioNTech appear furthest along in redesigning their shot.
In late January, they launched a clinical trial testing immune responses to a vaccine targeting Omicron in unvaccinated people, and as a booster in those fully vaccinated. Results are expected in April.
BioNTech has argued that laboratory analyses by other researchers showed that exposure to Omicron in previously vaccinated people leads to a broad immune response against major prior coronavirus variants, the sources said.
Lab tests of a BioNTech/Pfizer shot targeting the earlier Alpha and Delta variants yielded an immune response inferior to what would be expected from a single-variant vaccine, they added.
A combination vaccine could raise other difficulties, including exacerbating temporary side effects seen with current shots, GSK said. Cutting the dose to avoid that could jeopardize efficacy, but GSK said it was working on that.
(Additional Reporting by Francesco Guarascio in Brussels, Julie Steenhuysen in Chicago, Jennifer Rigby in London; Editing by Michele Gershberg and Bill Berkrot)
