U.S.-Based COVID-19 Vaccine Makers are Gearing up to Face Omicron with Biden Administration’s Help

While new COVID-19 variant Omicron is now charging across Asia and Europe, causing cancellations and travel bans, vaccine makers Moderna, Pfizer/BioNTech and Johnson & Johnson (J&J) each say they are already working to tackle it. And President Biden said the U.S. government is in touch with each company, ready to help accelerate contingency plans.

“In the event, hopefully unlikely, that updated vaccinations or boosters are needed to respond to this new variant, we will accelerate their development and deployment with every available tool,” Biden said in remarks yesterday about the new variant.

"We do not yet believe that additional measures will be needed," Biden added. "But so that we are prepared, if needed, my team is already working with officials at Pfizer and Moderna and Johnson & Johnson to develop contingency plans for vaccines or boosters if needed."

Biden added that he will also direct the FDA and the Centers for Disease Control and Prevention to use “the fastest process available without cutting any corners for safety to get such vaccines approved and on the market if needed.”

On Monday, Biden imposed a travel ban on passengers coming from South Africa and other southern African countries, where Omicron was first discovered.

The World Health Organization (WHO) designated Omicron, aka B.1.1.529, a variant of concern on Nov. 26, saying then that it’s not yet known whether it’s more transmissible or causes more severe symptoms. The WHO said it’s now coordinating with “a large number of researchers around the world” to better understand Omicron, adding that studies currently underway or underway shortly include assessments of transmissibility, severity of infection (including symptoms), performance of vaccines and diagnostic tests, and effectiveness of treatments. 

Meantime, J&J said yesterday that it’s testing blood serum from participants in completed and ongoing booster studies to look for neutralizing activity against the Omicron variant. In addition, the company said it’s pursuing an Omicron-specific variant vaccine and will progress it as needed.

“We remain confident in the robust humoral and cell-mediated immune responses elicited by the Johnson & Johnson COVID-19 vaccine demonstrated by the durability and breadth of protection against variants to date in clinical studies,” said Mathai Mammen, global head of Janssen Research & Development at J&J.

He added that J&J, via a long-term collaboration with scientists in South Africa and the ongoing real-world effectiveness studies the company is conducting, will work to generate new data on Omicron.

In parallel, Mammen said, the company has begun to design and develop a new vaccine against Omicron “and will rapidly progress it into clinical studies if needed.”

Moderna — the first vaccine maker with authorization in the U.S. to issue a statement on how it plans to tackle Omicron — announced last week that it’s already rapidly advancing its new variant-specific vaccine candidate against Omicron called mRNA-1273.529.

Moderna also said that it’s testing three existing COVID-19 vaccine booster candidates against the new variant, including a higher-dose booster of mRNA-1273 (100 µg).

“From the beginning, we have said that as we seek to defeat the pandemic, it is imperative that we are proactive as the virus evolves,” said Stéphane Bancel, CEO of Moderna, who added that for several days, the company has been moving as fast as possible to execute its strategy to address the new variant.

The recently described Omicron variant includes mutations seen in the Delta variant that are believed to increase transmissibility and mutations seen in the Beta and Delta variants that cause the immune system to no longer recognize and eliminate the virus, Moderna said.

“The combination of mutations represents a significant potential risk to accelerate the waning of natural and vaccine-induced immunity,” said the company.

Pfizer and BioNTech told FDAnews that the two companies “are remaining vigilant and constantly conducting surveillance efforts focused on monitoring for emerging variants that potentially escape protection from our vaccine.”

A Pfizer spokesperson said that the companies are beginning to run neutralization tests on Omicron and expect to have initial data in the coming weeks.

If Pfizer’s and BioNTech’s vaccine doesn't prove sufficiently protective against Omicron, the companies “expect to be able to develop and produce a tailor-made vaccine against that variant in approximately 100 days, subject to regulatory approval,” the spokesperson said.

Meantime, a small biotech in Africa is getting ready to try to make its own mRNA COVID-19 vaccine. Though many countries have vowed to donate vaccines to African countries, just 6 percent of Africa’s population is currently vaccinated against COVID-19. With assistance from the WHO and others, Afrigen Biologics and Vaccines is now Africa’s first training and technology transfer hub for mRNA vaccines. The problem: it still doesn't have the blueprint for making the vaccine as Moderna won’t share it.

Moderna did not respond to a request for comment on that situation. — Suz Redfearn