South African health authority approves Pfizer Covid-19 vaccine booster shot
The approval came hours after Pfizer issued a statement saying preliminary laboratory studies demonstrate that three doses of the Pfizer-BioNTech Covid-19 vaccine neutralise the Omicron variant.
The South African Health Products Regulatory Authority (Sahpra) on Wednesday approved a booster shot, under some conditions, for people who had previously received two doses of the Pfizer vaccine.
Sahpra CEO Dr Boitumelo Semete-Makokotlela said people over 18 may get a third dose at least six months after their second dose.
Sahpra also approved a booster vaccine for immunocompromised children, within 28 days after a second shot and for immunocompromised adults at least 28 days after the second dose.
Even though only one Pfizer shot is given to children between the ages of 12 and 17 in South Africa, due to a heightened risk of myocarditis in young boys, Yuven Gounden from Sahpra said these were the applications that Pfizer applied for and they were approved by the organisation.
Sahpra has not yet taken a decision on mixing and matching vaccines.
“The data provided only dealt with the situation of homologous boosting, where the third dose is of the same vaccine as the initial course (in this case, two doses). Sahpra is aware of the keen interest in the efficacy and safety of heterologous boosting regimens (so-called mix-and-match approaches), and invites submission of supportive data in this regard,” Semete-Makokotlela said.
Foster Mohale, a spokesperson for the National Department of Health, indicated earlier in the week that the department was ready to roll out booster shots as soon as Sahpra approved this, but after the Sisonke trial providing Johnson & Johnson boosters to health workers wraps up.
Sahpra’s approval of the booster shot comes hours after Pfizer issued a statement saying preliminary laboratory studies demonstrate that three doses of the Pfizer-BioNTech Covid-19 vaccine neutralise the Omicron variant, even though two doses still have significant efficacy against it.
According to the statement, a third shot of the Pfizer vaccine increased neutralising antibodies against the Omicron variant twenty-five-fold compared with two doses. The statement said three doses of the Pfizer vaccine offered similar protection as two doses did against the “original” virus.
The company said two doses may still protect against severe disease and added that it was developing a variant-specific vaccine for Omicron.
“Although two doses of the vaccine may still offer protection against severe disease caused by the Omicron strain, it’s clear from these preliminary data that protection is improved with a third dose of our vaccine,” said Albert Bourla, chairman and CEO of Pfizer.
“Ensuring as many people as possible are fully vaccinated with the first two-dose series and a booster remains the best course of action to prevent the spread of Covid-19.”
Ugur Sahin, CEO and co-founder of BioNTech, said: “Our preliminary, first dataset indicates that a third dose could still offer a sufficient level of protection from disease of any severity caused by the Omicron variant.
“Broad vaccination and booster campaigns around the world could help us to better protect people everywhere and to get through the winter season. We continue to work on an adapted vaccine which, we believe, will help to induce a high level of protection against Omicron-induced Covid-19 disease as well as a prolonged protection compared with the current vaccine.”
The announcement from Pfizer followed the publication of results from a study by a group of South African scientists, led by Professor Alex Sigal from the Africa Health Research Institute, showing that the Omicron variant had the ability to escape some of the protective effects of the Pfizer vaccine.
The study was supported by awards from the Bill & Melinda Gates Foundation, the National Institutes of Health and the South African Medical Research Council. Its members included Professor Salim Abdool Karim, Dr Anne von Gottberg from the National Institute for Communicable Diseases, Dr Richard J Lessells, who played a crucial role in first identifying the Omicron variant, and Professor Tulio de Oliveira.
Twelve people took part in the study, six of whom were vaccinated and infected with the Omicron variant, and six of whom were only vaccinated.
The study found that there were “strong suggestions” that Omicron could escape some antibody immunity induced by the Pfizer vaccine, but that considerable immunity is retained in people who were both vaccinated and previously infected. DM/MC
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