COVID-19 pill approved by FDA, Pfizer says it’s ready to start U.S. delivery ‘immediately’

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With case counts heading up in a hurry, it’s desperately needed. Even if those who are vaccinated and boosted have a low rate of severe illness, such breakthrough infections do occur. For the unvaccinated, there is so far mixed evidence that the lightning-fast spread of the omicron variant comes with any benefit in the forms of a milder disease. Rates of severe illness seem to be almost identical between omicron and delta in South Africa. However, a study out of Scotland suggests omicron produced only about one-third of the hospitalized cases when compared to earlier variants.

Even so, the high rate of contagion could more than outweigh any reduced rate of severe illness. Already U.S. news is full of reports of localized hospital overcrowding, delayed procedures, and an increasing rate of dropouts from overworked staff.

If Paxlovid can significantly impact the number of people going to the hospital, it can help prevent overcrowding of ICUs and hospital beds. Pushing down the occupancy rate of ICUs in particular could have a large impact on the rate of deaths as the U.S. meets the omicron surge. It might not turn a tsunami into a ripple, but it could prevent health care systems from facing drastic overcrowding, especially if targeted to areas under stress.

Despite Pfizer’s announced increases in production, the pills are expected to remain in short supply well into 2022. Manufacturing is complex, and creating a new batch takes months. The cost of a course of treatment is $530, but the government is expected to make the pills free to patients, as they have done with vaccines. 

In addition to U.S. regulators, the pill was approved earlier this week by  he European Medicines Agency (EMA); 2.75 million courses of treatment have been ordered by the U.K.

In addition to Paxlovid, there are three other potential treatments that have recently been in the news, one of which should be up for FDA approval shortly.

One of these is another antiviral pill, molnupiravir, manufactured by Merck. The FDA is widely expected to approve the use of molnupiravir within the next week. However, while the efficacy of the drug was good in initial Phase 1 testing, more extensive testing dropped that efficacy to only around 30%. A one-third reduction in severe illness is not nothing, and molnupiravir will certainly be administered, especially when other options aren’t available. 

The second new treatment is a new formulation of monoclonal antibodies from AstraZeneca. Other monoclonal antibodies have lost much of their effectiveness against omicron, but Evusheld has a different purpose. It’s specifically targeted at those who are immunocompromised in a way that makes them unable to take the vaccines, or prevents the vaccines from having an immune-stimulating effect. Evusheld is intended as a prophylaxis. That is, this is a preventive treatment, taken by people with immunological conditions, before they get sick.

Finally, there’s fluvoxamine, a drug which is already in wide use against depression and OCD. Like many existing drugs, fluvoxamine got a second look as a possible COVID-19 treatment. In this case, the drug’s anti-inflammatory effects recommended it for study. In one of those studies, fluvoxamine appeared to be spectacularly effective, raising great hopes for the treatment, but in two other trials that benefit seemed to evaporate. The FDA continues to recommend that “there is insufficient evidence for the COVID-19 Treatment Guidelines Panel to recommend either for or against the use of fluvoxamine for the treatment of COVID-19.” However, more trials are ongoing.





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