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COVID-19 vaccines against Omicron may be fast-tracked

Regulators including the Food and Drug Administration (FDA) may treat Omicron-specific mRNA vaccines like seasonal flu vaccines, speeding up approval

FDA

With cases of Omicron appearing across the world, it is clear that travel bans will not be enough to prevent the spread of the new SARS-CoV-2 variant of concern.

Attention is turning to the vaccines that most developed countries are relying on to control the COVID-19 pandemic, asking two key questions: will the existing vaccines work against Omicron and, iIf not, how quickly can manufacturers ‘tweak’ them to boost their efficacy?

In the last few days, Pfizer-BioNTech, Moderna and Johnson & Johnson have all announced that they have begun work on Omicron-specific versions of their existing vaccines.

Stéphane Bancel, CEO of Moderna, caused ripples when he predicted that existing vaccines would be much less effective at tackling Omicron than earlier strains of coronavirus.

“There is no world, I think, where [the effectiveness] is the same level [we] had with Delta,” he said. “{There is] going to be a material drop.

His warning that it would take months for companies to develop and manufacture variant-specific jabs at scale rattled investors, causing share indexes to fall across Europe and Asia.

Politicians and public health experts, however, have struck a more positive note. US President Joe Biden called Omicron “a cause for concern, not a cause for panic”, adding that the government’s medical experts “believe that the vaccines will continue to provide a degree of protection against severe disease”.

Scott Gottlieb, now working at Pfizer but previously commissioner of the US FDA agreed, saying there was “a reasonable degree of confidence in vaccine circles that [with] at least three doses… the patient is going to have fairly good protection against this variant”.

BioNTech CEO Uğur Şahin has been talking about the similarities he sees between tweaked COVID-19 vaccines and the seasonal flu vaccine, suggesting regulatory agencies such as the FDA could use flu as a blueprint.

“We are generating a dataset to get a blueprint process approved — to ensure that if a new variant pops up that requires an adaptation of the vaccine because the original vaccine doesn’t work anymore, we can just come up with a variant vaccine, and not do a large clinical trial,” he said.

Gottlieb agreed, saying the FDA was familiar with the mRNA vaccines and that they would seek “immunogenicity data, maybe neutralization studies” rather than “new outcomes studies”.

Jason Schwartz, associate professor at the Yale School of Public Health, suggested that clinical immunogenicity studies could be conducted in only one age group and with a much shorter post-vaccination monitoring period. “Those could be relatively small trials — on the order of a few thousand subjects, if I had to guess — with a short duration prior to submission to FDA. Much, much faster than the initial round of EUAs [emergency use authorisations].”

Article by
Hugh Gosling

30th November 2021

From: Healthcare

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