(FILES) This file illustration photo taken on November 17, 2020 shows vials with Covid-19 Vaccine stickers attached and syringes with the logo of US pharmaceutical company Johnson & Johnson. - Pharmaceuticals giant Johnson & Johnson on February 4, 2021 submitted an application for emergency authorization of its Covid-19 vaccine with US health authorities, the company said in a statement. (Photo by JUSTIN TALLIS / AFP)
(FILES) This file illustration photo taken on November 17, 2020 shows vials with Covid-19 Vaccine stickers attached and syringes with the logo of US pharmaceutical company Johnson & Johnson. - Pharmaceuticals giant Johnson & Johnson on February 4, 2021 submitted an application for emergency authorization of its Covid-19 vaccine with US health authorities, the company said in a statement. (Photo by JUSTIN TALLIS / AFP)

Covid-19 vaccine: Johnson & Johnson applies for emergency authorisation from SAHPRA

By Reuters Time of article published Feb 9, 2021

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CAPE TOWN - South Africa's lead investigator for the Johnson & Johnson trial, Professor Glenda Gray, said on Thursday the country's regulator was processing an application for the vaccine to be granted emergency authorisation against Covid-19.

Addressing a webinar on vaccines, Gray said they were in discussions with regulatory authorities to roll out the single-dose vaccine to health workers, after the government earlier this week temporarily halted the roll out of the AstraZeneca vaccine over efficacy concerns.

Earlier on Tuesday, South Africa was looking at ways to deploy AstraZeneca's Covid-19 vaccine after temporarily putting on hold plans to roll it out to healthcare workers, government advisers said on Tuesday.

The government had planned to start rolling out one million doses of the AstraZeneca shot later this month, but trial data published after they had arrived showed the vaccine offered minimal protection against mild-to-moderate disease caused by the country's dominant coronavirus variant.

South Africa now plans to start its vaccination programme with Johnson & Johnson shots in mid-February, after the US company promised to expedite deliveries.

Members of the government's Ministerial Advisory Committee said the plan was not to discard the AstraZeneca shots.

Rather, their use would be suspended until more evidence was available on whether the vaccine protects against severe Covid-19 from the 501Y.V2 variant, which is more contagious and currently accounts for more than 90% of the country's cases.

"AstraZeneca may well have a place, it may well have a significant place. This is only a suspension, not turfing it out," Professor Barry Schoub told Reuters.

"We have got in South Africa a problem with the variant, it all hinges on that."

Schoub said a number of options were being looked at for the AstraZeneca shots, including whether they could be used in combination with another vaccine, to see whether one dose "either the prime or the booster with the AstraZeneca may work well synergistically with another vaccine".

Another adviser, Professor Salim Abdool Karim, told Newzroom Afrika that a "two-step rollout" was being considered for the AstraZeneca vaccine.

After an initial round of vaccinations, hospitalisation rates would be assessed "and if we are happy that it's within the range we want to see, then we continue with the rollout," he said.

South Africa aims to vaccinate 40 million people, or two-thirds of the population, to achieve some level of herd immunity.

AstraZeneca's chief executive said on Tuesday that his company believed its vaccine should still protect against severe Covid-19. The British-Swedish firm said earlier that it was adapting its vaccine to the 501Y.V2 variant.

Karim suggested on Monday that South Africa could start by giving 100,000 people the AstraZeneca jab to see how well it worked on preventing hospitalisation and death.

But Schoub said that was still under discussion.

Separately, local pharmaceutical company Lamar International said it was looking to sell 15 million doses of Russia's Sputnik vaccine to the government.

It declined to name the price per dose, but said it could start supplying them if regulator SAHPRA granted approval for the vaccine to be used.

Reuters

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