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Pfizer, Merck Next-gen Pneumococcal Vaccines Score Key CDC Panel’s Backing on Way to Rival Rollouts Feedzy

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With a new vote from CDC vaccine advisors, the U.S. appears set for rival pneumococcal vaccine rollouts from two of the industry’s biggest players.

At a meeting Wednesday, CDC’s Advisory Committee on Immunization Practices (ACIP) voted to recommend Pfizer’s Prevnar 20 and Merck’s Vaxneuvance as routine immunizations to help protect against invasive disease caused by Streptococcus pneumoniae. Pfizer’s shot protects against 20 serotypes, while Merck’s defends against 15.

The advisors recommended the vaccines as routine immunizations for people 65 and older who haven’t previously received a pneumococcal conjugate vaccine, plus those 19 to 64 with certain risk factors. While Pfizer’s vaccine scored an ACIP recommendation as a one-and-done pneumococcal conjugate shot, the advisors said Merck’s vaccine should be followed by a dose of the company’s own pneumococcal polysaccharide vaccine Pneumovax 23.

Ahead of the meeting, there was a question of whether the advisors would “preferentially recommend” Pfizer’s vaccine over its Merck rival, Cantor Fitzgerald analyst Louise Chen wrote to clients on Wednesday. Since they didn’t, the recommendations set up a clash that “will have to be decided in the market.”

Meanwhile, because the advisors recommended the shots for the 19 to 64 group with risk factors, that development could “meaningfully increase the peak sales potential” for the shots, Chen wrote. It’s the first time any pneumococcal conjugate vaccine has been recommended for that group, the analyst said.

RELATED: On a vaccine roll, Pfizer scores FDA nod for Prevnar 13 follow-up ahead of rival Merck

Next up, ACIP’s recommendations head to CDC director Rochelle Walensky and to the Department of Health and Human Services for a final sign off. Once final, they’ll be published in the CDC’s Morbidity and Mortality Weekly Report.

Pfizer and Merck’s rival vaccines scored FDA approvals in June and July, respectively. For Pfizer, Prevnar 20 is a follow-up to the massively successful Prevnar 13, which before COVID-19 was the bestselling vaccine on the planet, generating about $6 billion annually.

Aside from their adult indications, the companies are racing to score FDA approvals for their next-gen vaccines in children. Merck has a lead in that age group and plans to submit its vaccine to the regulator this year, with Pfizer expected to follow next year.

RELATED: Racing rival Pfizer, Merck’s Vaxneuvance makes its case for an FDA approval in children

Also at Wednesday’s meeting, the advisors voted to recommend GlaxoSmithKline’s shingles vaccine Shingrix for people 19 and older who are immunocompromised.

Source Here: fiercepharma.com

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Inside the Catalent FDA Citation Said to Trigger Novo Nordisk’s Wegovy Supply Hiccup FiercePharma: Pharma

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Inside the Catalent FDA citation said to trigger Novo Nordisk’s Wegovy supply hiccup
fkansteiner
Tue, 01/18/2022 – 09:39

Article: fiercepharma.com

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Area Fitness Centers Busy Despite Omicron Surge

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Despite a recent surge in the omicron variant of COVID-19, area fitness centers are busy as many people made New Year’s resolutions to get in shape and get their health back on track.

Original Source: standardspeaker.com

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CAN DO: Niagara Bringing ‘family-sustaining Jobs’ to Hazleton

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An update on Niagara Bottling was among the topics the CAN DO board of directors heard Tuesday afternoon.

Source: standardspeaker.com

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