Pfizer submits booster dose application to SAPHRA amid looming fourth wave

SOUTH AFRICA – The South African Health Products Regulatory Authority (SAHPRA) has said it has received an application for the Pfizer booster shot.

According to the local drug watchdog, it will commence with the assessment of data for the safety and efficacy of the third dose.

This comes as the United States Food and Drug Administration (FDA) on Friday backed the emergency authorizations for booster shots of the Pfizer and Moderna COVID-19 vaccines.

As of 17 May, to 12 November 2021, 18,174,316 total Pfizer-BioNTech doses were administered with 3,574 total AEFIs reported. 5,160,790 total Vaccine Janssen doses were administered with 942 total AEFIs reported, SAPHRA has announced.

This means all adults in the US are now eligible for an additional shot six months after the second dose and may be given at any point after that time.

Pfizer’s latest request says results from a Phase 3 clinical trial with more than 10 000 participants found that the third dose was safe and effective,” SAHPRA said.

According to the World Health Organisation (WHO), booster doses are administered to a vaccinated population that has completed a primary vaccination series, currently one or two doses of COVID-19 vaccine, depending on the product.

This is done when immunity/clinical protection has fallen below a rate deemed sufficient, with the aim to restore vaccine effectiveness, the organization explained.

Last month, SAHPRA and Johnson & Johnson (J&J) approved vaccine booster doses for all healthcare workers who received the first shot as part of the Sisonke Study.

This was after the FDA recommended a second dose of the J&J vaccine for all Americans 18 years and older who received a single dose.

Early this year, the South African Medical Research Council (SAMRC), working with the National Department of Health (NDoH), Desmond Tutu Health Foundation, CAPRISA, and the pharmaceutical company came together to provide early access to J&J.

According to the Department of Health’s latest data, 81 840 J&J booster shots have been administered to healthcare workers since the rollout started this month.

On Monday, total of 13,473 tests were conducted, with 312 new cases, which represents a 2.3% positivity rate. A further 10 Covid-19 related deaths were been reported, bringing total fatalities to 89,584 to date.

South Africa, which is the most affected country in Africa by Covid, has so far reported well over 2.9 million cases.

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