SAHPRA registers Pfizer’s anti-viral medicine to treat COVID-19

SOUTH AFRICA – The South African Health Products Regulatory Authority (SAHPRA) has registered Paxlovid, an anti-viral medicine manufactured by Pfizer, to treat COVID-19.

Paxlovid, which contains Nirmatrelvir (150mg) and Ritonavir (100mg), is a medicine that is used for the treatment of mild to moderate COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe COVID-19.

Paxlovid consists of tablets for a 5-day oral treatment regimen, with morning and evening doses. Expected side effects include hypersensitivity reactions, diarrhoea, vomiting, and altered taste.

A shelf-life of twelve (12) months is approved for Paxlovid when stored at or below 25°C.

“SAHPRA is committed to fast-tracking the registration of all health products that are of an urgent nature such as HIV-AIDS, Cancer, and COVID-19. AS COVID-19 is a looming threat, the registration of Paxlovid heralds a welcome signal in the fight against this pandemic,” said SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.

This comes as South Africa announced that it does not see the need to implement any new COVID-19 restrictions either at home or for arrivals over an infection surge in China and the detection of the first case of Omicron subvariant XBB.1.5 locally.

“The dominant variant of concern in China and in the world remains Omicron, and the immunity of South Africans from vaccination and natural immunity is still very strong,” Health Minister Joe Phaahla said.

Phaahla said South Africa had not seen any major increase in its COVID infection, hospitalisation, or death rates recently.

It has sought advice from the World Health Organization and will increase COVID testing and reinvigorate its vaccination campaign in light of rising infections in countries like China and the United States, he added.

Health authorities intend to offer all adults additional COVID vaccine boosters towards the end of January.

So far, the country has only confirmed one case of the XBB.1.5 subvariant and there is no evidence that it is spreading, although the subvariant is believed to be highly contagious, Phaahla said.

South Africa has recorded the most COVID infections and deaths on the African continent, at more than 4 million infections and over 102,000 deaths.

Initially it battled to secure vaccines as rich countries hoarded the available shots, but it now has large volumes in stock.

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