J&J vaccine paused over rare blood-clots in US, Europe and SA

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Johnson & Johnson's coronavirus vaccine's rollout has been paused in South Africa, the United States and Europe, over blood-clotting concerns by the US Centres for Disease Control  and  the Food & Drug Administration, reports MedicalBrief.

However, leading vaccinologist Dr Shabir Madhi, of the University of the Witwatersrand, has urged South Africa to continue using the J&J vaccine. He told MedicalBrief  that with the current rates of COVID-19 in South Africa and an imminent resurgence, "the benefits of vaccination in preventing hospitalisation and deaths from COVID-19 far exceeds the risk of this rare possible side effect."

"Whilst some countries might have the luxury of being spoilt for choice of having access to different vaccines ( which too have rare side effects), this is not the case for SA and most low and middle income counties. We should continue vaccinating with JJ, and particularly targeted at individuals that are at high risk for severe Covid-19, among whom this sort of are side effects is even less common."


The New York Times
writes that the latest developments have dealt a fresh blow to Europe’s already beleaguered vaccination push.
Some European countries have already restricted use of the AstraZeneca vaccine for younger people, while other nations, like Norway and Denmark, are not administering it at all. "The troubles cast a cloud over the EU’s vaccine rollout just as it has finally begun to gain momentum after months of supply shortages and logistical problems. They risk further eroding Europeans’ willingness to be vaccinated.

In a joint statement, the US agencies said that more than 6.8 million doses of the J&J (Janssen) vaccine have been administered in the US. CDC and FDA are reviewing data involving six reported US cases of "a rare and severe type of blood clot". In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

"Although there appears to be an association  between CVST and thrombocytopenia and the Vector based vaccines, the incidence of this possibly side effect of vaccination is extremely low at 1-4 per million of vaccinated individuals. With the current rates of Covid in SA. and an imminent resurgence- the benefits of vaccination in Preventing hospitalisation and deaths from COVID-19 far exceeds the risk of this rare possible side effect. Whilst some countries might have the luxury of being spoilt for choice of having access to different Covid vaccines ( which too have rare side effects), this is not the case for SA and most low and middle income counties . We should continue vaccinating with JJ, and particularly targeted at individuals that are at high risk for severe Covid-19, among whom this sort of are side effects is even less common," the statement read.

Health Minister Dr Zweli Mkhize said in a statement that although there had not been any reports of such clots having formed after vaccination, after having inoculated 289 787 health care workers under the Sisonke Protocol, South Africa's scientists had advised that "we cannot take the decision made by the FDA lightly". "Based on  their advice, we have determined to voluntarily suspend our rollout until the causal relationship between the development of clots and the Johnson and Johnson vaccine is sufficiently interrogated.

"SAHPRA will collate information from Johnson and Johnson, the FDA and other regulatory bodies to make a thorough assessment of the situation and advise us as a regulatory body that has exercised its authoritative powers on the approval of the vaccine in their own right. We hope that the deliberations will only take a few days … and we expect that this will not result in the complete withdrawal of the Johnson and Johnson vaccine from the vaccination armament."

"I am glad to say, however, that there are good news in the midst of this development. I am happy to announce that we have successfully negotiated for another 10 million doses from Pfizer and, of these, we expect just under 2 million to be delivered in May. This therefore means we have secured 30 million doses of Pfizer vaccine for this financial year.

"This also reassures us that, in the extremely unlikely event that Johnson and Johnson rollout is completely halted, we will not have any impediment to proceed with phase two of the rollout with Pfizer. We are confident that the rollout of Johnson and Johnson will resume and so, with 30 million doses of Johnson and Johnson and 30 million doses of Pfizer secured we now have enough doses to exceed the 40 million we were targeting this year. This is in line with our commitment to vaccinate as many people as possible in this financial year- in the ideal scenario we would vaccinate every single adult found in South Africa."

 

Business Insider reports that Tuesday of last week (6 May 2021), 62m of the company's vaccine doses had be checked for contamination, following an error at a Maryland manufacturing plant that had already previously had ruined 15m doses. The plant's workers accidentally mixed up some vaccine ingredients last month.

Then, Business Insider reports, a vaccination site in Colorado, three sites in North Carolina, and one in Georgia all temporarily stopped administering Johnson & Johnson's shot after about 45 people in total experienced minor adverse reactions involving nausea, dizziness, fainting, or light-headedness.

To top it off, European regulators announced Friday last week that they are investigating Johnson & Johnson's shot for links to unusual blood clotting after four blood-clot cases, including one death, were reported among vaccine recipients.

The timing of these developments was unfortunate, experts said, but there's no reason to doubt the shot's safety yet. "You don't want to be fuelling unnecessary worries about the safety of vaccines when you're still seeing an enormous outbreak and death rates all over the world from COVID," Art Caplan, a bioethicist at New York University, is quoted in Business Insider as saying.

He added that the side effects observed at the US vaccination sites were "absolutely trivial." Although symptoms like nausea and fainting aren't common responses to coronavirus vaccines, they aren't abnormal, either. "When you see these clusters [of side effects], they usually are worked out and have no relation to the vaccine," Arnold Monto, an epidemiologist at the University of Michigan School of Public Health, said. Monto chairs the US Food and Drug Administration's Vaccine Advisory Committee, which voted to recommend the Pfizer, Moderna, and Johnson & Johnson shots.

Business Insider reports that most of the negative reactions to Johnson & Johnson's shot occurred within 15 minutes after a person got vaccinated, public-health officials in Colorado, Georgia, and North Carolina reported. In total between the three states, seven people were taken to hospitals for observation. As of Friday, all but one had been released and everyone was expected to fully recover.

"This is a really potent vaccine, and what we're seeing is some of that potency relating at a very rare side effect that we just have to be aware of," said Dr David Agus, a CBS News medical contributor is quoted as saying.

CBS News reports that all three major US vaccines produced adverse reactions in more than 60,000 people nationwide. For each manufacturer – Pfizer, Moderna and Johnson & Johnson – just one-tenth of 1% of all people have reported side effects.

 

Full New York Times report (Open access)

Full Business Insider report (Open access)

Full CBS News report (Open access)


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