COVID tablet replace: Pfizer seeks emergency FDA approval as US buys 10M programs

Pfizer says its COVID-19 antiviral pill reduces risk of serious illness: What we know about US approval

Pfizer has requested for emergency use authorization for its COVID-19 antiviral tablet.

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For probably the most up-to-date information and details about the coronavirus pandemic, go to the WHO and CDC web sites.

Saying Pfizer’s COVID-19 antiviral tablet “might show to be one other important software in our arsenal that can speed up our path out of the pandemic,” President Joe Biden immediately stated his administration has bought 10 million programs of the Pfizer oral drug. The announcement comes two days after the drug-maker requested the Meals and Drug Administration to authorize the tablet for emergency use.

Pfizer stated its oral drug might lower the danger of hospitalization or loss of life from COVID by 89%, in line with knowledge from medical trials. Referred to as Paxlovid, Pfizer’s tablet can be taken orally to battle the extreme signs. At present, the one antiviral treatment approved within the US requires a well being care skilled to manage the treatment intravenously, via a needle, over 5 to 10 days. A straightforward-to-take tablet might grow to be a part of a rising toolkit that medical doctors might use to battle COVID, which already consists of the three COVID vaccines approved to be used within the US. Merck additionally has an antiviral drug within the works it’s in search of FDA approval for.

In September, knowledge from Johns Hopkins College confirmed that round 1 in 500 Individuals have died from the coronavirus. Whereas the out there COVID-19 vaccines are extremely efficient, hundreds of thousands of Individuals haven’t been vaccinated. Based on a September report from the Facilities for Illness Management and Prevention, unvaccinated persons are over 10 instances extra prone to get hospitalized and die from the illness than totally vaccinated individuals.

This is what we learn about Pfizer’s antiviral tablet. We’ll replace this story as extra particulars emerge. For extra on COVID-19, here is the most recent on vaccine mandates, holding your vaccine card helpful and this yr’s flu season.

What’s Pfizer’s COVID-19 antiviral drug?

Within the US, the three authorized COVID vaccines from Moderna, Pfizer and Johnson & Johnson can shield you from an infection. However for these already contaminated, antiviral medicine might cut back the possibility of great sickness and cut back the danger of hospitalization and loss of life.

If authorized, Pfizer’s drug will not change the necessity for vaccines. Well being officers see the vaccines and antiviral medicine working in tandem to tame the pandemic: Vaccines can forestall an infection and reduce the severity of sickness when you get contaminated. Antiviral medicine can reduce the consequences of the sickness, together with for these unvaccinated.

In medical trials, Paxlovid — taken together with ritonavir, a drug used to deal with HIV — decreased the danger of hospitalization or loss of life by 89% when taken three days of signs for individuals who are at a better danger of great an infection, Pfizer stated. 

Throughout its medical trials, Pfizer stated, reported unwanted side effects between these taking the antiviral drug and people taking the placebo have been about the identical.

What number of programs of the COVID drug is the US authorities shopping for?

Pfizer stated the Biden administration has bought sufficient of the antiviral drug for 10 million remedy programs. A remedy course runs 5 days. See under for extra.

Pfizer stated it can start delivering the primary doses of the drug to the federal government later this yr and proceed via 2022. In a press release, Biden stated his administration is working to ensure the remedies “shall be simply accessible and free.”

Will the FDA authorize Pfizer’s drug?

Pfizer on Tuesday requested the FDA for emergency use authorization for its antiviral drug. The New York Occasions reported Pfizer is in search of authorization proper now only for use with unvaccinated individuals.

How does it evaluate with molnupiravir, Merck’s COVID tablet?

Merck utilized for an emergency use authorization of its antiviral tablet with the FDA in mid-October. 

Merck has stated its tablet — additionally meant to be taken orally at residence — can cut back the danger of hospitalization and loss of life by 50% if taken inside 5 days of the onset of signs for individuals who have examined optimistic and are at greater danger of great sickness. 

An FDA advisory committee plans to fulfill on the finish of November to think about Merck’s emergency use software for molnupiravir.

When might Pfizer’s antiviral tablet be out there within the US?

The New York Occasions reported that Pfizer’s tablet might be out there in a number of weeks, if authorized by the FDA.

What can be Pfizer’s remedy course for its antiviral tablet?

Throughout Pfizer’s assessments on the drug, sufferers took the tablet orally each 12 hours for 5 days.

Will Pfizer’s drug be free?

Biden in a press release stated the antiviral remedies shall be “simply accessible and free” together with his administration’s buy of 10 million remedy programs. Individually, the US authorities is buying 1.7 million programs of Merck’s antiviral drug to offer if and when it’s authorized by the FDA.

For extra on COVID-19, here is the most recent on COVID-19 vaccines for teenagers, what to learn about mixing and matching vaccines and what’s taking place with booster pictures.

The data contained on this article is for instructional and informational functions solely and isn’t meant as well being or medical recommendation. At all times seek the advice of a doctor or different certified well being supplier concerning any questions you will have a couple of medical situation or well being targets.

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