European Drug Regulator Authorizes the use of Pfizer Drug against COVID-19 in the EU

Health | December 17, 2021, Friday // 10:46|  views


EU countries can use Pfizer’s anti-viral pills – Paxlovid, to treat COVID-19 in the early stages of diagnosis, although the approval process is not yet complete, the EU's drug regulator said.

Patients at high risk of severe disease should start a five-day course of paxlovid as soon as possible after diagnosis or within 5 days of symptoms, but not if additional oxygen is needed, reads the opinion of the European Medicines Agency (EMA).

"The agency's board can now be used to support national recommendations for the possible use of the drug before a marketing authorization is granted," the statement said.

The EMA has previously allowed the use of some injectable antibody-based drugs in a similar way, and this is happening at a time when governments are rushing to strengthen their arsenal to fight Omicron. It is possible that the new coronavirus variant has already developed resistance to some of these drugs, Reuters notes.

Amid an increase in new coronavirus cases in Europe, the EMA made a similar decision last month for Merck's molnupivir pill. The agency advised that it be taken within five days of the onset of the first symptoms for the treatment of adult patients who do not need oxygen support and are at risk of worsening the disease.

According to data released this week, the Pfizer pill is almost 90 percent effective in preventing hospitalizations and deaths in high-risk patients, and according to the latest data from laboratories, the drug remains effective against the rapidly spreading version of Omicron.

The EU is still negotiating the purchase of Merck and Pfizer drugs. It is not clear when or whether the European Commission will launch a joint procurement procedure for these drugs and how many countries will secure supplies through the European scheme or purchase them individually.

Pfizer said Tuesday it expects approval from the US Food and Drug Administration and other regulators.

The decisions come amid attempts to tackle the rise in infections in Europe, which threatens to overwhelm health systems, and amid the rapid spread of Omicron. This has prompted some governments to reintroduce restrictions ahead of the Christmas holidays, according to Reuters.


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Tags: paxlovid, molnupivir, Merck, Pfizer, drug, pill, covid, omicron


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