Pfizer to allow more nations to make COVID drug, files for EUA with FDA

Pfizer today announced that it has signed a voluntary licensing agreement to expand production of its new COVID-19 treatment, Paxlovid, for low- and middle-income countries, which follows a similar announcement from Merck for molnupiravir.

Also today, Pfizer announced that it has applied for emergency use authorization from the US Food and Drug Administration (FDA) for Paxlovid. The Biden administration plans to buy 10 million treatment courses of the Pfizer drug, sources told NBC News.

Deal would ease access for 95 countries

In its licensing announcement, Pfizer said it signed an agreement with the Medicines Patent Pool (MPP), a United Nations-based group, enabling MPP to boost international production by granting sublicenses to generic medicine producers.

The deal will allow the drug combo to be manufactured in 95 countries, covering 53% of the world population. The companies will waive royalties on drug sales in those countries as long as COVID-19 remains a public health emergency of international concern.

Albert Bourla, Pfizer's chairman and chief executive officer, said the company believes oral treatments can play a key role in reducing illness severity and the strain on health systems.

On Twitter today, Soumya Swaminathan, MD, chief scientist at the World Health Organization (WHO), said the WHO welcomes the development and that its guidelines group will review the data when available and make recommendations.

In late October, Merck and partners Ridgeback Therapeutics and Emory University signed a similar deal with MPP to allow pharmaceutical companies in other countries to make molnupiravir, another investigational oral antiviral. The deal would speed availability to 105 low- and middle-income countries.

Paxlovid, a SARS-CoV-2 protease inhibitor given orally, is designed to be given at the first sign of illness at home to avoid serious illness or death. The drug blocks the SARS-CoV-2 protease that the virus needs to replicate. It is given with a low dose of ritonavir, an HIV antiviral that can boost the level of other protease inhibitors. The two drugs are given twice a day for 5 days.

Interim clinical data suggests a 89% reduction in hospitalization and death from any cause when Paxlovid was taken 3 days after COVID-19 symptom onset, compared with placebo. Researchers saw similar results when taken within 5 days of symptom onset.

Though the anticipated arrival of oral COVID-19 drugs has been widely hailed as a game-changer for helping ease the pandemic, some experts worry that patients will face challenges navigating testing and getting treated within the time frames in which the drugs are effective.

More global headlines

  • In Europe, cases are rising in Portugal, one of Europe's most highly vaccinated nations, according to Reuters. Cases have risen to a 2-month high, prompting health officials to consider tightening restrictions.

  • Spain's Basque region and neighboring Navarra are the country's main hot spots, and officials in the Basque region today announced restrictions on gatherings to curb the spread of the virus, according to the New York Times.

  • In other European developments, the Netherlands today reported a daily record high for cases, and Ukraine reported a single-day high for deaths.

  • Bulgaria—with Europe's lowest COVID-19 vaccine uptake—showed a 50% increase in deaths for September, the highest excess morality in Europe, according to the Eurostat report that details death levels compared with prepandemic months.

  • The global total today rose to 254,225,731 cases, along with 5,112,821 deaths, according to the Johns Hopkins online dashboard.

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