As the World Works to Understand Omicron, Cases Increase Internationally and Vaccine Manufacturers Weigh In

As people are waking up to learn more about the latest on the COVID-19 Omicron variant, there are developments on many fronts.

Japan announced its first case of someone with the variant and now there are 18 countries and territories who have cases of people infected with it.

Yesterday, the World Health Organization (WHO) released a new risk assessment for the COVID-19 variant. “The overall global risk…is assessed as very high,” according to the organization.

In light of the news about the variant, the Centers for Disease Control and Prevention strengthened their recommendation that all individuals 18 and older receive an additional "booster" vaccine dose. Adults are eligible for a booster shot 6 months after a regimen of Pfizer-BioNTech or Moderna or 2 months after a dose of the Janssen (Johnson & Johnson) vaccine.

Vaccine Manufacturers Weigh-In

Moderna CEO Stéphane Bancel voiced his concern on the efficacy of the currently available COVID-19 vaccines. In an interview with the Financial Times, “There is no world, I think, where [the effectiveness] is the same level . . . we had with [the] Delta [variant],” Bancel said. “I think it’s going to be a material drop. I just don’t know how much because we need to wait for the data. But all the scientists I’ve talked to . . . are like, ‘This is not going to be good.’”

It is important to note, that Moderna had previously said in a statement late last week it was going to develop an Omicron-specific booster candidate, mRNA-1273.529. The company said it is part of their strategy to advance variant-specific candidates for a subset of variants of significant concern. This year, this included Beta- and Delta-specific boosters.

In the same statement, Bancel said the company was also working on 2 other “lines of defense,” including a higher dose of the booster of mRNA-1273 (100 µg), and it was studying 2 multi-valent booster candidates that were designed to anticipate mutations and is “expected in the coming weeks.” 

It has been reported, that Pfizer and BioNTech will seek approval sometime this week for a booster dose of their COVID-19 vaccine for 16- and 17-year-olds.

In an interview with CNBC’s “Squawk Box,” Pfizer CEO Albert Bourla said although no one knows yet how efficacious the vaccines will be against the variant, he also voiced doubt.

“I don’t think that the result will be the vaccines don’t protect,” Bourla said. “I think the result could be, which we don’t know yet, the vaccines protect less.”

Bourla was optimistic about the company’s Investigative protease inhibitor antiviral combination pill, PF-07321332 and ritonavir (Paxlovid). It was reported earlier this month that the therapy was associated with a nearly 90% reduction in risk of hospitalization and/or death at 28 days among patients with COVID-19.

“The good news when it comes to our treatment, it was designed with that in mind, it was designed with the fact that most mutations are coming in the spikes,” Bourla said in the interview. “So that gives me very high level of confidence that the treatment will not be affected, our oral treatment will not be affected by this virus.”

In mid-November, Pfizer announced it had submitted data to the Food and Drug Administration for an Emergency Use Authorization (EUA) of this therapy.

“With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options,” Bourla said in a statement at that time. “The overwhelming efficacy achieved in our recent clinical study of Paxlovid, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19.”