By Sara G. Miller -
NBC News
Additional data from Pfizer's clinical trial on its oral antiviral against COVID-19 confirms the high level of efficacy of the treatment, the company reported in a press release Tuesday.
In the final analysis of its phase 2/3 clinical trial, the antiviral, called Paxlovid, was found to be 89% effective in preventing high-risk people from being hospitalized or dying from the coronavirus, the company explained.
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The findings are consistent with the results of the interim analysis the company released last month, although the full data has not been made public for scientists to review.
Pfizer stopped its clinical trial based on the interim results and submitted an emergency use authorization request to the Food and Drug Administration (FDA) several weeks later.
The FDA has not scheduled a meeting of its advisory committee to review the application.
Paxlovid, a Pfizer coronavirus pill, in a factory in Freiburg, Germany.Pfizer / via Reuters
Experts say that an antiviral pill for COVID-19 would have a major impact on the pandemic by making treatment available at home.
Current treatments are only available by injection or intravenously.
A complete Pfizer treatment consists of three pills taken twice a day for five days.
Two of the pills are an experimental antiviral called nirmatrelvir.
The third pill is an existing HIV medicine called ritonavir.
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Treatment prevents the coronavirus from making copies of itself in the body.
Paxlovid has been shown to be most effective when given within three days of symptoms, according to the company.
The side effects, which were similar in people who received Paxlovid or the placebo, were mostly mild, according to the news release.
The company did not detail them.
Pfizer also released interim results of a second clinical trial that looked at the effectiveness of treatment in unvaccinated low-risk people, as well as in people vaccinated with one or more risk factors for severe disease.
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According to the results, Paxlovid did not relieve coronavirus symptoms compared to placebo, but it did reduce hospitalizations by 70%.
Pfizer noted that laboratory studies suggest that the treatment is effective against the new omicron variant of the virus, although more research is needed to confirm this.
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The FDA advisory committee narrowly voted last month to recommend an antiviral from drug company Merck for emergency use authorization.
The FDA has not yet approved the drug, called molnupiravir.
Merck's treatment was found to be 30% effective in preventing hospitalization or death from COVID-19 in high-risk patients.
Members of the advisory committee raised concerns about the drug's safety, including potential risks to pregnant women and their fetuses.