American pharma giant Pfizer, which developed mRNA Covid-19 vaccine along with German firm BioNTech, has submitted its application to the Food and Drug Administration (FDA) for emergency authorisation of its five-day antiviral pill regimen, Paxlovid.
This is the second such drug looking for approval, as the fellow drugmaker, Merck asked the federal agency to grant emergency authorisation for its Covid pill, called molnupiravir, last month.
If Pfizer receives FDA approval, this might revolutionise the fight against Covid-19 by allowing high-risk persons infected with the novel coronavirus to take an oral antiviral medicine at home rather than travelling to the hospital.
According to Pfizer, when treated within three days of the onset of symptoms, the combination of Paxlovid and an HIV drug called ritonavir reduced hospitalisation and death by 89 per cent in adults 18 and older at a higher risk of developing severe Covid-19.
According to reports, Pfizer's application to FDA came just a few days after the company disclosed that the drug regimen's clinical trial had been ended early due to strong evidence that it worked.
But this is not the first time that a clinical trial is halted before the completion to benefit more people. Earlier, an independent group of medical professionals overseeing the trials of Merck’s anti-Covid pill molnupiravir, suggested that it be terminated early because the preliminary results were so promising.
However, Pfizer has started producing and packaging the medicine in plants in Ireland, Germany and Italy, with 180,000 tablet packs expected to be accessible by the end of the year and 50 million by 2022.
Covid Pill And 95 Developing Nations
Meanwhile, the company has agreed to make and sell its experimental Covid-19 therapy tablet in 95 developing countries including India — where, as per the latest reports, the Subject Expert Committee is expected to make a decision on recommending approval to molnupiravir soon.
The agreement with the non-profit Medicines Patent Pool, which is supported by the United Nations, may make the medication available to 53 per cent of the world's population.
As reported, while Covid remains a World Health Organization-designated public health emergency, Pfizer will not collect royalties for the sales in low-income countries and has stated that it will waive royalties in all those nations participating in the deal.
According to Charles Gore, head of the Medicines Patent Pool, the licence is crucial since "this oral drug is particularly well-suited for low- and middle-income countries and could play a critical role in saving lives", reported BBC.
While in this case, the majority of the countries are from Africa and Asia continent, nations that have seen severe outbreaks, including Brazil, China, Russia, Argentina and Thailand, are not included in the agreement. This move has been criticised by an international medical non-governmental organisation, called Doctors Without Borders.
According to the organisation, it was "disheartened" that the deal doesn't make the medication available everywhere in the world. The group's legal policy adviser Yuanqiong Hu said: "The world knows by now that access to Covid-19 medical tools need to be guaranteed for everyone, everywhere, if we really want to control this pandemic."
However, The Washington Post reported that the American government has also pre-purchased 3.1 million molnupiravir treatment courses for $2.2 billion. Merck anticipates that 10 million treatment courses will be available by the end of the year and has also licensed its medicine to the Medicines Patent Pool.
Additionally, the report noted that this week, the Joe Biden administration is expected to announce that it has obtained 10 million courses of Pfizer anti-Covid treatment.
So now it is believed that these two anti-Covid treatment options could be game-changers in the fight to halt the pandemic.
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