No cover up, says Prof Glenda Gray as she defends distribution of J&J vaccine
Medical Research Council president Prof Glenda Gray told parliament on Wednesday that South Africans were well aware that the distribution of the Johnson & Johnson Covid-19 vaccine to health workers was being done as part of a study and was not the actual rollout.
“I do not think we are covering up for anything. We held press conferences, we went on television with the minister. If you go on to our website, to the Electronic Vaccine Date System, you will see the consent forms. It is very clear and public that this is a phase 3B open-label study,” said Gray, who is also the co-principal investigator of the J&J implementation study.
Gray and her team appeared before parliament’s portfolio committee on health, where they gave an update on the J&J clinical trials. Responding to a question from the EFF’s Naledi Chirwa, Gray said that the Sisonke study aimed to vaccinate 500,000 health-care workers.
“As the rollout begins, we will work closely with the Department of Health to transition the sites to roll out vaccines, which will either be J&J or Pfizer. As far as I understand — I am not talking on behalf of the Department of Health — the J&J agreements have been signed. There is a schedule of vaccines that are available and I am sure that the Department of Health can indicate when these vaccines will come,” she said.
Gray said the national vaccine programme was “stalled or paused” on February 9 after data was released showing that the AstraZeneca vaccine was not effective for mild and moderate infection from the dominant Covid-19 variant in SA.
“We moved rapidly to start the phase 3B open-label study to replace the national rollout, and the reason we did this was because health-care workers are three to four times more likely to develop Covid-19,” Grey explained.
Globally, she said, one in seven Covid-19 cases are health-care workers. To date in SA, more than 40,000 such workers had contracted the disease and just fewer than 6,500 had been hospitalised. Around 650 health-care workers had died.
“To transition to the J&J study was almost a no-brainer. This is a single-dose vaccine and it can protect against severe disease,” said Grey, adding that this included protection against the dominant variant in SA.
Allaying fears, she said SA should not be alarmed if there was a shortage of vaccines in the next two months — because, afterwards, “vaccines are going to flow because the global manufacturing would have taken place”.
“And from what I can see, according to the global reports, after July there will be massive access to the vaccines. I think the Department of Health will announce the number of vaccines that are coming into the country in the next couple of months,” she said.
In terms of the Russian vaccine Sputnik and China’s Sinovac, Gray said: “We know that there are issues of efficacy in Brazil with Sinovac, and again this points to the need for local data. We cannot extrapolate from other countries because we are dealing with different variants.”
Gray said it was important to have local evidence that a particular vaccine worked before administering it to citizens.
“We don’t want to roll out vaccines where we do not know the efficacy,” she said.
Gray said the National Treasury had given R150m to conduct the J&J study, which translated to about R500 or R600 per person — which she believed was “incredibly cost effective”.
“We have got up to half a million doses from J&J to conduct this phase 3B open-label study. When we knew that we could not go ahead with the AstraZeneca rollout, we approached J&J for these vaccines, and these vaccines were all over the world.
“These vaccines are flown in and then placed into a warehouse and once there are enough doses they are sent to SA. And that is why we have got up to 80,000 doses every 14 days because these vaccines are being collected to be shipped back to SA.
“The last vaccines, which will be 200,000 doses, were in the US. We had to get approval from the FDA [the US Food and Drug Administration], we had to get permission from the US government, to allow them to release these vaccines. There is a global shortage of vaccines, and 200,000 doses coming to SA from the US could cause diplomatic issues.”
Gray said it was important that while the negotiations were happening SA did not ruin any of its diplomatic ties.
“So we had to make sure that everyone understood that this was for the phase 3B open-label study and that the vaccines were not being taken away from US citizens. So obviously these things take time and a lot of negotiations and a lot of logistical operations and so the last 200,000 doses will come in about two weeks’ time and that will conclude the doses we get.”
Gray said the vaccines will be delivered and administered, and that will conclude the half a million phase 3b open-label study that is now being conducted.
She encouraged those who have been vaccinated and are showing side effects to report them immediately.
On a possible third wave, Gray said: “Yes, I think we are all worried about the third wave, particularly after the April weekend, Easter holidays, and as we go into winter, as we spend more time indoors, the third wave is imminent.
“If you watch our burden of disease, we give out a weekly mortality rate and there is a slight uptick, which we will need to keep an eye on. And we need to make sure that we monitor the excess deaths.”
On the effect of banning alcohol, Gray said: “We saw the impact of alcohol on motor vehicle accidents, emergency rooms and violence. We have definitely noted that when there is alcohol control in our country, the emergency rooms are more manageable and unnatural deaths go down. I think we do need more robust alcohol regulations.
“I think we need to increase the age of people who drink alcohol to 21. I think we need to empower tavern owners and bar owners to withhold alcohol from people who should not be drinking more,” she said.
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