Morning Briefing
Summaries of health policy coverage from major news organizations
CDC Endorses Moderna, Pfizer Covid Vaccines Over J&J Shot
USA Today: CDC Recommends Pfizer, Moderna COVID Vaccines Over J&J In Adults
A CDC panel voted Thursday to recommend the Pfizer-BioNTech and Moderna COVID-19 vaccines be preferred for adults over the Johnson & Johnson vaccine due to a small number of very rare but dangerous blood clots. Out of approximately 17 million people in the United States who have gotten the J&J vaccine, there have been nine deaths from the condition called thrombosis with thrombocytopenia, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices said Thursday. The CDC acted hours later, accepting the panel's recommendation. (Weise, 12/16)
The Wall Street Journal: CDC Recommends Pfizer, Moderna Covid-19 Vaccines Over J&J’s
The updated position is likely to deal another blow to the use of the J&J shot, whose uptake had been hurt by manufacturing issues and earlier reports of J&J vaccine recipients, especially women, experiencing blood clots combined with low blood-platelet levels. There have been at least 54 cases of the condition, thrombosis with thrombocytopenia syndrome, or TTS, among J&J vaccine recipients in the U.S., including nine resulting in deaths, CDC officials said Thursday. (Loftus, 12/16)
NPR: CDC Narrows Use Of J&J Vaccine Amid Concerns About Blood Clots
In a statement, Johnson & Johnson said it "remains confident in the overall positive benefit-risk profile" of its vaccine. "The safety and well-being of those who use the Johnson & Johnson vaccine continues to be our number one priority," said Dr. Mathai Mammen, head of drug research and development at Johnson & Johnson, in the statement. "We appreciate today's discussion and look forward to working with the CDC on next steps." (Romo and Hensley, 12/16)
And the Novavax vaccine is 90.4% effective —
CIDRAP: Novavax COVID Vaccine Shows 90.4% Efficacy Against Infection
A phase 3 trial yesterday in the New England Journal of Medicine (NEJM) finds that the Novavax COVID-19 vaccine is 90.4% effective against infection and 100% effective against moderate to severe illness, bringing yet another vaccine one step closer to approval. Novavax is a new adjuvanted, recombinant spike protein nanoparticle vaccine that has proven effective against COVID-19 infection in the United Kingdom and South Africa. This was the first such trial in North America. (Van Beusekom, 12/16)
Reuters: Novavax COVID-19 Vaccine Could Get EU Approval Next Week
Novavax's COVID-19 vaccine could receive approval from Europe's drug regulator next week and subsequently an emergency use listing from the World Health Organization, the Financial Times reported on Thursday, sending shares of the U.S. drugmaker up 7%. A WHO approval could come once the health body issued its own emergency use listing or if the EMA gave it a conditional marketing authorization, the newspaper reported, citing people familiar with the matter. (12/16)
In updates on the Pfizer vaccine —
Reuters: Eight Heart Inflammation Cases Among Young Kids Who Got COVID-19 Shot - U.S. CDC
The U.S. Centers for Disease Control and Prevention said on Thursday it had received reports of eight cases of myocarditis, a type of heart inflammation, in children aged 5-11 years who received Pfizer and BioNTech's COVID-19 vaccine. The CDC had previously said that reporting rates of myocarditis for boys aged 16 to 17 could be more than 69 cases per million second doses administered and around 40 cases per million second doses in boys aged 12-15 years old. (12/16)
The Hill: Pfizer And BioNTech Seek Full Vaccine Approval For Those Ages 12-15
Pfizer and BioNTech announced on Thursday evening that they had submitted an application to the Food and Drug Administration (FDA) seeking full approval for the administration of their two-dose COVID-19 vaccine in children aged between 12 and 15.The companies said in a release that their application included follow-up data from their Phase 3 clinical trial, which showed that two doses of the vaccine were 100 percent effective against COVID-19 among 12 to 15-year-olds. (Choi, 12/16)
