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COVID-19 vaccine maker BioNTech expects updated omicron-specific shots by October

Washington Examiner logo Washington Examiner 8/8/2022 Cassidy Morrison
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BioNTech, with its partner Pfizer, expects to begin deliveries of two omicron-adapted vaccines as soon as October in time for a fall vaccination campaign ahead of another COVID-19 surge.

The German company announced the start of clinical trials for the coming vaccines in its Monday revenue report, in which leaders said BioNTech came up short on sales and earnings expectations for the second quarter by about 40% each from a year earlier. But BioNTech executives anticipate a rebound come fall.

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“With our initiatives around variant-adapted COVID-19 vaccine candidates, we expect an uptake in demand in our key markets in the fourth quarter of 2022, subject to regulatory approval,” BioNTech Chief Financial Officer Jens Holstein said.

The updated vaccines are meant to be better equipped to stave off infection due to BA.4 and BA.5, two omicron offshoots that are believed to be the most transmissible variants of COVID-19 so far. BioNTech and Pfizer submitted one of the adapted vaccines, which targets the BA.1 omicron subvariant, to the European Medicines Agency last month for authorization. The other vaccine candidate targeting offshoots BA.4 and BA.5 will begin clinical trials this month.

“Our COVID-19 product pipeline includes variant-adapted and next-generation vaccine candidates aimed at prolonged and broad protection,” BioNTech CEO Ugur Sahin said.

The new boosters will be bivalent vaccines, meaning they target the original “wild type” strain of COVID-19 as well as the omicron subvariants. Their unveiling is expected to coincide with a seasonal spike in infections, as has been the case yearly since the pandemic began. The Food and Drug Administration’s panel of vaccine experts has come out in favor of retooling shots to target omicron BA.4 and BA.5 given their dominance in the United States. BA.5 accounts for more than 85% of COVID-19 cases in the U.S., while BA.4 accounts for nearly 8%.

"The better the match of the vaccines to the circulating strain we believe may correspond to improved vaccine effectiveness and potentially to a better durability of protection," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research told the scientists at the agency’s June meeting.

Moderna, the other COVID-19 vaccine maker that relies on mRNA technology to confer immunity, is also engineering an updated booster to target omicron cousins and has agreed to sell the federal government 66 million doses of its bivalent vaccine booster for use in the fall and winter, provided it receives authorization from the FDA and the Centers for Disease Control and Prevention. The government inked another deal with Pfizer-BioNTech last month to purchase 105 million doses of bivalent boosters to be delivered in the fall at the earliest.

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But the Department of Health and Human Services warned that those acquisitions will only make a dent in the volume of people who need protection from the latest omicron mutation. The agency has been lobbying Congress for months to pass additional funding to purchase more vaccines, tests to diagnose COVID-19, and treatments including Paxlovid and monoclonal antibodies.

The deals with Pfizer and Moderna included options for a total of 600 million doses, 300 million from each company, but those options can only be exercised with additional funding from Congress, the agency said.

 

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Tags: Coronavirus, Vaccination, HHS, FDA, Pfizer

Original Author: Cassidy Morrison

Original Location: COVID-19 vaccine maker BioNTech expects updated omicron-specific shots by October

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