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Morning Briefing

Summaries of health policy coverage from major news organizations

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Friday, Aug 6 2021

Full Issue

Moderna Vaccine Maintains 93% Efficacy Through First Six Months

The final analysis of Moderna's Phase 3 trial shows that its shot offers "durable efficacy" against symptomatic covid through six months. The drugmaker is planning to apply for full Food and Drug Administration approval this month.

Fox News: Moderna Says Its COVID-19 Vaccine 93% Effective After 6 Months

A final analysis of late-stage trial data indicated Moderna’s COVID-19 vaccine was 93% effective 6 months after the second dose, the company announced Thursday. An analysis released last fall suggested the shot was 94% effective in preventing COVID-19. "We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months, but recognize that the Delta variant is a significant new threat so we must remain vigilant," Stéphane Bancel, CEO of Moderna, said in part in a company announcement posted Thursday. (Rivas, 8/5)

CNN: Moderna's Covid-19 Vaccine Shows 93% Efficacy Through 6 Months, As Company Expects To Finish Application For Approval This Month 

Moderna's Covid-19 vaccine showed 93% efficacy against symptomatic disease through six months, and the company expects to complete its application for full approval from the US Food and Drug Administration this month, the company said Thursday. The efficacy data came from a final analysis of the vaccine's Phase 3 study, which enrolled thousands of participants who received both doses last year, before it was made available to the wider public. "In final analysis" of the study, "the Moderna Covid-19 vaccine showed 93% efficacy, with the efficacy remaining durable through six months after administration of the second dose," Moderna said in a news release. (Thomas and Hanna, 8/5)

The J&J covid vaccine shows strong protection against the delta variant —

Bloomberg: J&J Vaccine Up To 96% Protective Against Death In Mass Trial

Johnson & Johnson’s Covid-19 vaccine helps prevent severe disease among those infected with the delta variant, according to a trial involving almost 480,000 health workers in South Africa. The study, known as Sisonke, provides the first large-scale evidence that the J&J vaccine works against this dominant variant, according to trial co-lead Glenda Gray. It’s probably more protective against delta than it was with the earlier beta strain, she said in a presentation Friday. The single-dose shot was 71% effective against hospitalization and as much as 96% effective against death, she said. It also demonstrated durability of eight months. (Kew and Sguazzin, 8/6)

In other updates from Novavax, Pfizer and Moderna —

The New York Times: Novavax Says U.S. Will Pause Funding For Production Of Its Vaccine 

Novavax, the Maryland firm that won a $1.75 billion federal contract to develop and produce a coronavirus vaccine, said on Thursday that the federal government would not fund further production of its vaccine until the company resolves concerns of federal regulators about its work. The firm’s disclosure came in a quarterly filing with the Securities and Exchange Commission. The Trump administration agreed to buy 110 million doses of vaccine from Novavax as part of its crash vaccine development program. (LaFraniere, 8/5)

CNBC: Novavax Covid Vaccine: FDA Emergency Use Submission Delayed To Q4

Novavax announced that it will delay the submission of its Covid-19 vaccine to the Food and Drug Administration for emergency use authorization until its fourth quarter. Shares of the biotechnology company slipped 10% after the bell. The company has filed for regulatory approval in India, Indonesia and the Philippines. Plans to submit the vaccine for emergency use listing at the World Health Organization are set for August, Novavax announced. Approval by the WHO will allow the vaccine to be distributed globally via vaccine sharing initiatives at the global agency. (Mendez, 8/5)

Axios: Pfizer, Moderna Dominate COVID-19 Vaccine Sales 

The four main drug companies making COVID-19 vaccines have sold a combined $18.6 billion worth of the shots in the first half of 2021, and sales are expected to reach a combined $60 billion by the end of the year. Even though the U.S. represents less than 5% of the global population, the U.S. market makes up 41% of the vaccine sales. (Herman, 8/5)

And in news about covid treatments —

CIDRAP: REGEN-COV Works As COVID Post-Exposure Prophylaxis, Study Says 

Using the monoclonal antibody cocktail REGEN-COV reduced the risk for symptomatic COVID-19 infection 81% in those exposed to a COVID patient, according to a New England Journal of Medicine study yesterday. The findings were used in the US Food and Drug Administration's recent decision to expand the drug's emergency-use authorization; now, it can be used as post-exposure prophylaxis in high-risk populations, not just a treatment during infection. (McLernon, 8/5)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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