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RSV vaccine: Moderna, Pfizer start a new FDA approval race

By: Eric Rosenbaum

The Covid vaccine is here to stay after a development process that broke the record books at both Moderna and Pfizer, but a new golden age ofvaccines may only be at its beginning.

Both companies have released results from RSV vaccine trials with efficacy results strong enough to expect expedited approval from the FDA. The latest was Moderna, which on Tuesday night share results from its RSV vaccine trial of over 37,000 individuals in 22 countries, effective at preventing lower respiratory tract disease.

Pfizer, whose RSV vaccine is focused on pregnant women able to transfer the antibodies to the fetus and offer protection for the first six months of life, previously released efficacy results of approximately 82% for the first 90 days of a child’s life.

The companies — which have been involved in litigation brought by Moderna alleging mRNA patent infringement, a claim Pfizer disputes — are both expecting to be in the FDA approval process for their RSV vaccines to relatively quickly.

Pfizer’s vaccine is already in the FDA approval process and Moderna CEO Stéphane Bancel told CNBC from Davos on Wednesday that it will be filing for FDA approval for its vaccine soon — it even had a plan in place for top executives to be ready to submit over the holidays if needed.

Pfizer CEO Albert Bourla downplayed the legal issues on Wednesday, offering his congratulations to Moderna and telling CNBC, it was “good news because we need to have options.”

He said while you cannot make direct comparisons between the two trials and he had not seen full safety data from Moderna, the efficacy looked to be “at same range as our efficacy, more or less,” and he expected if all the data checked out, his vaccine competitor would proceed soon. Pfizer, he said, already has priority review in the FDA approval process because of the data set’s strength and because the disease does not have vaccine.

“I’m sure if the Moderna data is as expected, it will be approved,” Bourla said.

The Moderna vaccine was 83.7% effective in preventing RSV with two or more symptoms, in people ages 60 and older, and it was 82.4% effective at preventing lower respiratory tract disease with three or more symptoms. No safety concerns were identified during the clinical trial, according to Moderna, which has yet to publish safety and efficacy data from the trial in a peer-reviewed journal, but plans to do so. Bancel told CNBC that common side effects of this type of virus vaccine, such as fever, were only slightly higher in those receiving the RSV shot in the trial (4%) versus those in the control group getting a placebo (2.8%).

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