J&J vaccine strongly protects against COVID-19
Phase 3 data shows one-dose vaccine 100% effective at preventing COVID-19-related deaths, 66% effective at preventing moderate-to-severe disease. FDA decision expected within days.
The US average is now about 65,000 new cases and 2,000 deaths a day, according to the CDC. These are down more than 25% over last month - but still higher than almost anywhere else in the world.
The day began with release of the FDA scientists’ analysis and other details of the Johnson & Johnson single-dose COVID-19 vaccine, which will be reviewed by FDA advisors on Friday. The data based on more than 39,000 subjects treated with active vaccine or placebo looks very strong. The vaccine, known as Janssen Ad26.COV2.S, could be cleared for emergency use as early as this weekend. If the EUA is issued, the White House says 3-4 million doses will be distributed next week, 20 million by the end of March and the full commitment of 100 million doses by mid-summer.
There were zero deaths among subjects who received the vaccine, vs. seven COVID-related deaths in the placebo group.
The vaccine was effective at preventing about 66% of moderate or severe COVID-19 disease.
In South Africa, where the B.1.351 variant is dominant, the efficacy was 52%.
Side effects were mostly minor - mostly headache or fatigue within two days of vaccination.
There were 14 circulatory or cardiovascular events among those who got the vaccine, vs. 10 in the placebo group.
Although researchers found no indications that these events were caused by the vaccine, FDA experts say that even if the vaccine is an “unlikely” cause, the data is insufficient to exclude the vaccine as a contributing cause.
Health workers in Ghana will be the first people in the world to get vaccinated as part of the global COVAX vaccine sharing initiative, backed by nearly 200 nations. The first shipment of Oxford/AstraZeneca vaccines arrived in Accra on Wednesday.
The White House announced that it will distribute more than 25 million cloth masks to community health centers and food pantries so that anyone who needs masks can get easily get them. Distribution is targeted to vulnerable people who may not have ready access to quality, reusable masks, according to White House COVID-19 coordinator Jeff Zients.
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