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FDA advisers recommend clearance for Pfizer's shot

Coronavirus Daily
Bloomberg

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FDA advisers back clearance for Pfizer shot

A U.S. vaccination campaign is starting to draw nearer.

The first Covid-19 shot expected to be deployed in the U.S. won the backing of a panel of government advisers Thursday. Now, an emergency use authorization could come within days, and with it, the quick deployment of immunizations. 

The decision wasn't unanimous. A Food and Drug Administration advisory panel voted 17 to 4, with one abstention, that the benefits of the vaccine from Pfizer and BioNTech outweigh the risks for use in people ages 16 and older. The FDA doesn't have to follow the recommendation, though often it does agree with its advisers.

But part of the panel discussion focused on whether there was enough data to support the vaccine's use in 16 and 17 year olds, leaving some pediatricians on the advisory committee uncomfortable with voting in its favor. Other members said data from older trial participants could be extrapolated to younger people.

The U.S. government expects about 2.9 million doses of the vaccine to be available to states almost immediately after FDA authorization. States will make the final decisions about who gets inoculated first, though advisers to the Centers for Disease Control and Prevention have recommended health-care workers and long-term care facility residents be prioritized.

The vaccine employs a technology called messenger RNA that's never before been used in human immunizations. The advisers, a group of independent experts, discussed the companies' experimental data, which the agency confirmed showed the shot was 95% effective and worked well regardless of age, gender, race, ethnicity or underlying conditions that cause people to be at high risk of severe Covid-19 symptoms.

Among almost 44,000 participants in the Pfizer clinical trial, there were eight virus cases within the group who received the shot and 162 in those who got a placebo, according to FDA staff. Side effects of the shot were mild and developed more frequently in those aged 55 and younger, with no signs of serious safety concerns based on two months of trial data, FDA staff found. After the second injection, fatigue and headache were among the most common reactions.

More than 290,000 people have died from Covid-19 in the U.S. Now it appears that an effective weapon may be on the way.—Anna Edney

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South Korea's Blueprint for Success

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Photographer: SeongJoon Cho/Bloomberg

Photographer: SeongJoon Cho/Bloomberg

 

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