South Africa Rejects 2 Million J&J Vaccines Due to FDA Decision | World news

By MOGOMOTSI MAGOME, Associated Press

JOHANNESBURG (AP) – The deployment of the COVID-19 vaccine in South Africa has suffered further delays as it will have to throw away at least 2 million Johnson & Johnson vaccines produced in the country.

The vaccines were deemed unsuitable for use by the United States Food and Drug Administration due to possible contamination of their ingredients at a facility in Baltimore. South Africa expected to use them to immunize its health workers and people aged 60 and over.

This is the latest setback in the vaccine rollout in South Africa, which has so far delivered vaccines to just over 1% of its 60 million people.

Earlier this year, the country rejected around 1 million doses of the AstraZeneca vaccine it received from the Serum Institute of India after a small preliminary study found the vaccine offered minimal protection against mild to moderate cases. of the COVID-19 variant which is dominant in South Africa. These vaccines were sold to the African Union for distribution in other African countries.

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To date, the country has administered vaccines to more than 1.7 million people, including nearly 480,000 health workers who have been vaccinated as part of a study trial of the Johnson & Johnson vaccine.

Production of the J&J vaccine at Aspen Pharmacare’s manufacturing facility in South Africa in the eastern town of Gqeberha, formerly known as Port Elizabeth, was eagerly anticipated to give the campaign a much needed boost. vaccination program of the country. The factory contracted with J&J to produce the vaccine using large quantities of basic ingredients supplied by Johnson & Johnson. The South African factory then mixes these components and puts them into vials – a process known as “fill and finish”.

The South African plant has the capacity to produce around 200 million doses of J&J vaccine annually and had already manufactured 2 million. But they were produced using ingredients from the Baltimore plant, so they should not be used, according to the decision of the FDA and South African health authorities.

The South African Health Products Regulatory Authority issued a statement saying it had “reviewed the data provided by the FDA and made the decision not to release the vaccines produced using the drug batches. that did not suit “.

South Africa will now only receive 300,000 doses of the J&J vaccine that have been cleared by the FDA, he said.

Aspen will begin production of new J&J vaccines this week using fresh, uncontaminated ingredients at its facilities, President Cyril Ramaphosa announced this week.

South Africa has purchased and expects delivery of 30 million doses of Pfizer vaccine and 31 million Johnson & Johnson single-injection vaccines by early 2022. These deliveries are needed for South Africa to reach its goal of vaccinating 40 million people by February 2022.

South Africa is currently experiencing a new resurgence of the COVID-19 pandemic with an increase in the number of recorded infections. Its 7-day moving average of daily new cases has more than doubled in the past two weeks, from 5.69 new cases per 100,000 people on May 30 to 12.17 new cases per 100,000 people on June 13.

It has recorded 7,657 new infections and 59 deaths in the past 24 hours, bringing the number of people who died from the virus to 57,765.

South Africa has been hardest hit by COVID-19 on the continent, with more than 1.7 million confirmed cases, nearly 40% of the more than 5 million cases reported by the 54 countries of Africa.

Copyright 2021 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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