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Pfizer Seeking EUA for oral Covid Treatment

22.11.2021 - Pharma giant Pfizer has filed an application with the US Food and Drug Administration seeking an Emergency Use Authorization (EUA) for its Paxlovid-branded antiviral oral CovidD-19 treatment. Specifically, the company is seeking authorization for the oral drug to be used in treating mild to moderate disease in patients at a higher risk of hospitalization and death.

The pill works by stopping the coronavirus from multiplying, using the antiviral PF-07321332 in combination with ritonavir, a drug used to treat HIV.

Pfizer’s application is the second to come before an FDA advisory panel, following an application submitted in October by US Merck and its partner Ridgeback Biotherapeutics for authorization of their own Covid treatment molnupiravir (Lagevrio). The panel is slated to discuss the Merck drug on Nov. 30.

As part of a rolling review, the European Medicines Agency (EMA) is currently also studying Lagevrio, which Ridgeback licensed from Emory University in Atlanta, Georgia, USA. The name chosen by the researchers derives from Möjlnir, the hammer of Thor in Norse mythology.

Pfizer said earlier that clinical trials found that the pill – recommended to be taken by high-risk patients twice a day for five days – could reduce the risk of hospitalizations and deaths by 89%. Of the participants receiving Paxlovid, the New York drugmaker said only three were hospitalized, and none died. In the placebo group there were 27 hospitalizations and seven deaths. Merck claims a reduction of only 50% in the same category.

US government to buy 10 million Pfizer courses

The administration of US president Joe Biden last week said it had agreed to buy 10 million courses of Pfizer’s Covid treatment for $5.29 billion, once it is approved. This injection of state funds will allow the company to make the first deliveries during 2021, with the arrangement planned to be extended into 2022.

In what sounded like a plea for regulatory approval, Xavier Becerra, Secretary of Health and Human Services, said the government’s deal with Pfizer would help ensure that millions of courses are available to US Covid patients if it is authorized. Moreover, these treatments could accelerate the country’s path out of the pandemic.

Pfizer and Merck to license their treatments

On the heels of a similar plan by Merck, Pfizer has announced that it will license its Covid treatment to generic drugmakers to facilitate affordable global access. Distribution will take place in part under an agreement with the Medicines Patent Pool (MPP), a United Nations-backed organization that works to increase access to life-saving medicines by pooling intellectual property and encouraging generic manufacturing.

Pfizer said it will license Paxlovid worldwide, allowing sub-licensees to supply 95 countries that account for 53% of the world's population. In late October, New Jersey-based Merck and its partner Ridgeback inked a similar deal with the MPP that will allow poor countries to manufacture molnupiravir.

Both companies’ plans foresee production of the drugs anywhere, with one restriction being that sales must be made in the same countries. Indian drugmakers are eager to get into the game. Alongside Dr. Reddy’s, which signed on with Merck ahead of the  FDA application, Aurobindo, Cipla, Emcure, Hetero, Sun and Torrent, as well as Beximco of Bangladesh, have said they will make the Merck product, and some of them will likely also make Pfizer’s.

Pfizer said it will not receive royalties on sales of the Covid treatment in low-income countries and additionally will waive royalties in all countries participating in the agreement for as long as the World Health Organization (WHO) continues to classify Covid-19 as a public health emergency of international concern.

Since being established in 2010, the MPP has closed other deals to provide affordable access to treatments for HIV, hepatitis C and tuberculosis.  

US approves boosters for all ages

Both US national health agencies, the Food and Drug Administration and the Centers for Disease Control have approved the extension of eligibility for Covid-19 vaccine boosters for Americans of all ages. The reversal re-establishes the original plan of the Biden administration the president put in place in September.

Both the FDA and the CDC followed the recommendations of their advisory panels and restricted access to boosters to those 65 years old or older and those whose professions put them at risk of infection. The agencies changed their stance, however, as Covid infections began inching upward again with the arrival of cool weather in much of the country.

As in many other countries, the mRNA-based vaccines will be used for the third shot, or the second in the case of Johnson & Johnson, which was originally intended to be a single-dose vaccine. The Pfizer/BioNTecj booster dose will be the same formulation at the same strength as the original two shots. The FDA has authorized a half-dose for the Moderna vaccine.

Author: Dede Williams, Freelance Journalist

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