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Scott Hensley

Updated January 3, 2022 at 11:34 AM ET

The Food and Drug Administration has authorized the use of a Pfizer-BioNTech booster in adolescents 12 to 15 years old.

The agency on Monday also shortened the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 vaccine and a booster dose to five months from six.

The U.S. Food and Drug Administration has authorized the second antiviral pill to treat COVID-19 at home.

The medicine, called molnupiravir and made by Merck and Ridgeback Biotherapeutics, is taken twice a day for five days. Merck says it will have 10 million packs available by the end of the month.

Updated December 23, 2021 at 3:37 PM ET

A federal agency has released the first allocations of Paxlovid, the new COVID-19 treatment from Pfizer, to states and territories. The federal government has a contract for 10 million courses of the treatment and is providing the medicine free to state and territorial health departments.

The government acknowledges that supplies will be tight to start.

Updated December 16, 2021 at 8:07 PM ET

The Centers for Disease Control and Prevention accepted advice from a panel of experts to recommend the use of the Moderna and Pfizer-BioNTech COVID-19 vaccines over the Johnson & Johnson jab, following growing concerns about rare blood clots.

Pfizer released additional data about its pill to treat COVID-19 that shows it was effective in preventing hospitalization and death when taken by people with mild to moderate illness within a few days of first symptoms.

The medicine, called Paxlovid, is taken twice a day for five days in combination with a second medicine called ritonavir, a generic antiviral.

A panel of experts advising the Food and Drug Administration voted narrowly in favor of emergency use authorization of an antiviral pill from Merck and Ridgeback Biotherapeutics to treat COVID-19.

The vote was 13 for and 10 against authorization. The FDA isn't obligated to follow the recommendations of its advisers but typically does.

Updated November 19, 2021 at 6:15 PM ET

CDC Director Rochelle Walensky is giving the green light to COVID-19 vaccine boosters for all adults.

The announcement came just hours after a vaccine advisory committee voted unanimously to expand Moderna and Pfizer-BioNTech vaccine boosters to everyone 18 and older.

The world is approaching the second anniversary of a cluster of cases of respiratory illness traced to the Huanan Seafood Market in Wuhan, China, in December 2019. The cause: a virus we now know as SARS-CoV-2.

The World Health Organization named the illness caused by the virus COVID-19 in February 2020, as cases mounted in China and began spreading elsewhere.

Where are we now in the COVID-19 pandemic and where are we headed?

Moderna says a study in kids 6 to 11 found two doses of the company's COVID-19 vaccine given 28 days apart produced a strong antibody response.

The study, conducted in collaboration with the National Institutes of Health, used shots containing a 50 microgram dose of the vaccine, half the dose of the Moderna shots authorized for adults. More than 4,700 children ages 5 to 11 took part in the study.

The most common side effects were fatigue, headache, fever and pain at the site of injection. The company says the analysis showed a "favorable safety profile."

Pfizer and its partner BioNTech say their data supports authorization of their COVID-19 vaccine in kids 5 to 11.

The Food and Drug Administration released the companies' briefing document Friday morning in a prelude to a meeting of expert advisers to the agency scheduled for Tuesday.

The Centers for Disease Control and Prevention is backing the roll out of Moderna and Johnson & Johnson COVID-19 vaccine boosters in line with the Food and Drug Administration's authorizations issued Wednesday. The CDC is also supporting a mix-and-match approach to booster vaccination.

CDC director Rochelle Walensky called the recommendations an "example of our fundamental commitment to protect as many people as possible from COVID-19."

The announcement came just hours after the CDC's vaccine advisory committee voted unanimously in favor of booster doses.

The Food and Drug Administration authorized booster doses of the COVID-19 vaccines made by Moderna and Johnson & Johnson following unanimous votes by a committee of independent advisers backing the boosters last week.

In a related decision, the FDA also authorized boosters that differ from the vaccine originally used to immunize a person against COVID-19. So, for instance, a person who got a Johnson & Johnson vaccine could receive one from Moderna or Pfizer-BioNTech as a booster.

A panel of experts voted unanimously to recommend that the Food and Drug Administration authorize a booster dose of the Johnson & Johnson COVID-19 vaccine.

In a 19-0 vote, the panel recommended that the booster dose come at least two months after initial immunization with one shot of the J&J vaccine. It applies to people 18 years and older.

During the meeting, J&J presented data that showed the protection of the single shot remained largely stable over time but that a second dose pushed protection to a higher level.

A panel of advisers to the Food and Drug Administration on Thursday unanimously recommended that the agency authorize a booster dose of the Moderna COVID-19 vaccine at least six months after completion of the initial two-dose regimen.

The recommendation applies to people 65 years and older, those 18 to 64 who are at high risk of severe COVID-19 and those people in the same age group whose work or institutional exposure puts them at high COVID-19 risk.

The recommendation mirrors the authorization that the FDA gave to Pfizer-BioNTech COVID-19 booster doses in September.

A Food and Drug Administration analysis of Johnson & Johnson's application for authorization of its COVID vaccine booster tees up deliberations at a public meeting of agency advisers Friday. The document was posted Wednesday.

The Food and Drug Administration released briefing documents Tuesday on booster shots for the Moderna and Johnson & Johnson COVID-19 vaccines ahead of a two-day public meeting of advisers to the agency that starts Thursday.

Moderna's COVID-19 vaccine booster is half the dose of the initial shots used in its two-shot vaccination — 50 micrograms of mRNA versus 100 micrograms.

The Food and Drug Administration authorized a booster dose Wednesday of the Pfizer-BioNTech COVID-19 vaccine for people 65 and older and others at high risk of severe COVID-19.

The FDA says the vaccine can also be given to people ages 18 to 64 whose jobs or institutional exposure to the coronavirus puts them at high risk of serious complications of COVID-19.

In a surprising vote, a panel of advisers to the Food and Drug Administration on Friday recommended against approval of a booster dose of the Pfizer-BioNTech COVID-19 vaccine for people 16 years and older.

The 16-2 vote against broad use of the booster, which would be given about six months after completion of the two-dose immunization regimen, dealt a setback to Pfizer and complicates the FDA's approach to boosters.

Updated September 15, 2021 at 1:51 PM ET

The Food and Drug Administration released an analysis by Pfizer on the need for a booster shot of the Pfizer-BioNTech COVID-19 vaccine.

Pfizer's analysis says data from Israel and the United States in the context of the delta variant suggests "that vaccine protection against COVID-19 infection wanes approximately 6 to 8 months following the second dose."

Updated August 23, 2021 at 12:52 PM ET

The Food and Drug Administration has formally approved Pfizer's COVID-19 vaccine. The widely anticipated decision replaces the emergency use authorization granted by the agency last December.

The vaccine, developed by Pfizer and its partner BioNTech, is the first COVID-19 vaccine to be subject to a full review by the U.S. regulator and to get an approval that puts the vaccine on par with other marketed vaccines.

Updated June 7, 2021 at 3:11 PM ET

The Food and Drug Administration approved the drug aducanumab to treat patients with Alzheimer's disease on Monday. It is the first new drug approved by the agency for Alzheimer's disease since 2003.

Updated March 24, 2021 at 11:03 PM ET

AstraZeneca's latest data analysis affirms effectiveness of its COVID-19 vaccine and is roughly in line with the results released Monday.

A third COVID-19 vaccine is on the way, and this one requires only one shot for immunization.

The Food and Drug Administration authorized Johnson & Johnson's vaccine for emergency use Saturday, a day after a panel of advisers to the agency voted unanimously (22-0) in its favor.

In a unanimous 22-0 vote, a panel of advisers to the Food and Drug Administration recommended that the COVID-19 vaccine developed by Johnson & Johnson be authorized for emergency use in adults during the pandemic.

The vote in favor of the vaccine, which requires only one shot for protection, was taken to answer this question: Do the benefits of the Johnson & Johnson vaccine outweigh its risks for use in people 18 years of age and older.

The Food and Drug Administration released an analysis of Johnson & Johnson's COVID-19 vaccine Wednesday morning that supports its authorization for emergency use.

On Friday, a panel of advisers to the agency will meet to evaluate the vaccine and make a recommendation about whether it should be given the OK. If the agency goes on to authorize the Johnson & Johnson vaccine, it would be the third, after those made by Pfizer-BioNTech and Moderna, to become available in the U.S.

A global study of nearly 44,000 found that the COVID-19 vaccine made by Johnson & Johnson is 66% effective in preventing moderate to severe disease.

The study was conducted in the U.S., Latin America and South Africa. The vaccine did better at preventing disease in the U.S. – 72% — and less well in South Africa – 57% efficacy. The efficacy seen in Latin America was 66%.

The biotech company Novavax says its COVID-19 vaccine is 89% effective at preventing the illness, according to an interim analysis of a large study conducted in the U.K.

The results come from a clinical trial involving more than 15,000 volunteers, of whom more than a quarter were older than 65.

The company says 62 cases of COVID-19 were seen in the study. Fifty-six occurred in the group that got placebo; six were seen in people who received the vaccine.

As the rollout of COVID-19 vaccines unfolds in the U.S., numerous questions around distribution, supply, hesitancy and efficacy persist. Experts from Harvard and the CDC will tackle these questions.

Watch an expert panel discussion on the effort to deploy against COVID-19 on Friday, Jan. 22, to be live-streamed here at 12 p.m. ET, as part of The Forum at the Harvard T.H. Chan School of Public Health.

You can email your questions to theforum@hsph.harvard.edu.

In a 20-0 vote, with one abstention, a panel of advisers to the Food and Drug Administration recommended that the COVID-19 vaccine being developed by Moderna be authorized for emergency use in adults during the pandemic.

If the agency authorizes the vaccine for emergency use, as is expected, it would become the second to be deployed in the U.S to fight the coronavirus.

The vote in favor of the vaccine was taken to answer the agency's question: Do the benefits of the Moderna vaccine outweigh its risks for use in people age 18 and older?

The Food and Drug Administration released a detailed analysis Tuesday morning of the COVID-19 vaccine from drugmaker Moderna that supports the authorization of the company's vaccine for emergency use.

The FDA's briefing document along with one from Moderna were posted two days before a group of experts will convene to advise the agency on whether to grant the vaccine emergency authorization for use, or EUA, during the pandemic.

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