South Africa suspended giving Johnson & Johnson vaccine shots Tuesday as a “precautionary measure” and the company delayed its European vaccine rollout following the FDA decision to pause using the jabs while very rare blood clot cases are examined.
South Africa has given more than 289,000 jabs of the J&J vaccine to the country's health workers without any reports of blood clots, Health Minister Dr Zweli Mkhize told reporters.
He said South Africa was halting the use of J&J jabs “out of an abundance of caution” and he expects that the questions over the J&J vaccine should “be cleared within a matter of days.”
Earlier, Johnson & Johnson said it was delaying the rollout of its coronavirus vaccine across Europe amid the US probe, a move that experts worried could further shake vaccine confidence and complicate Covid-19 immunisation efforts.
The announcement came after regulators in the United States said they were recommending a “pause” in the single-dose shot to investigate reports of rare but potentially dangerous blood clots.
“We have made the decision to proactively delay the rollout of our vaccine in Europe,” Johnson & Johnson said.
The delay is a further blow to vaccination efforts in the European Union, which have been plagued by supply shortages, logistical problems and concerns over unusual blood clots in a small number of people who received the AstraZeneca vaccine, which is made by a process similar to the J&J shot.
The blood clot reports prompted several countries in the 27-nation bloc to limit the AstraZeneca vaccine to older people, which are more at risk from serious illness and death when infected with Covid-19.
The bloc's drug regulator, the European Medicines Agency, has authorized the AstraZeneca shot for all people 18 and over.
Many leading Covid-19 vaccines train the body to recognize the spike protein that coats the outer surface of the coronavirus. But the J&J and AstraZeneca vaccines use a cold virus, called an adenovirus, to carry the spike gene into the body. Johnson &Johnson uses a human adenovirus to create its vaccine, while AstraZeneca uses a chimpanzee version.
In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating six cases of unusual clots that occurred six to 13 days after vaccination with the J&J shot.
All six cases were women between 18 and 48, including one who died. The FDA commissioner said she expected the pause to last a matter of days.
The European Medicines Agency said it is “currently not clear” whether the J&J shot was responsible for the rare clotting disorders.
Last week, the EU drug regulator said it found a “possible link” between the AstraZeneca shot and rare blood clots but that the benefits of vaccination far outweighed the risks of Covid-19. It noted the risk of such clots is less than the blood clot risk that healthy women face from birth control pills.
Dr Adam Finn, a professor of pediatrics at Britain's University of Bristol, said it was possible the way the J&J and AstraZeneca vaccines were made may have contributed to the unusual clotting disorders in a very small proportion of people.
“This may help give us a clue towards understanding the mechanism or a way to prevent this problem from occurring,” Finn said in a statement. "Investigation of this phenomenon is now an extremely urgent international priority.”
The EU ordered 200 million doses of the Johnson & Johnson in 2021. Britain ordered 30 million doses of the J&J vaccine, though UK regulators have not yet authorized its use.
France had expected to receive 200,000 doses of the vaccine this week and was planning to start administering them next week to people aged 55 and over. In total, France had planned to receive about 8 million doses of the J&J vaccine by the end of June.
In February, South Africa began vaccinating its health workers with the J&J vaccine in a research trial after abandoning plans to use the AstraZeneca shot when a preliminary study suggested the AstraZeneca vaccine was only minimally effective against the variant of Covid-19 that first arose in the country.
Last month, the African Union announced it had signed a deal to buy up to 400 million doses of the J&J vaccine. Johnson & Johnson also has a preliminary agreement to supply up to 500 million doses to the UN-backed COVAX initiative, an effort to provide vaccines to the world's poor.
Any concerns about the J&J vaccine could be another unwelcome complication for COVAX and for the billions of people in developing countries depending on the program. COVAX recently was hit by supply issues after its biggest supplier, the Serum Institute of India, announced it would delay exports of the AstraZeneca vaccine for several months due to a surge of cases in the subcontinent.
European regulators on March 11 endorsed the Johnson & Johnson vaccine as the fourth authorized for use in the EU, but the first supplies are only now arriving. (AP) CPS CPS
Following the FDA news, J&J said it was delaying the rollout of the vaccine to Europe.
South Africa's health regulator approved J&J's one-shot vaccine two weeks ago, but it has only been given to health workers in a research study so far. The government expects to receive its first batch of commercial doses later this month, as part of a deal with J&J for 31 million doses.
Mkhize said the government had negotiated an additional 10 million Covid-19 vaccine doses from Pfizer, meaning 30 million shots of that two-dose vaccine had now been secured.
"This also reassures us that, in the extremely unlikely event that Johnson & Johnson rollout is completely halted, we will not have any impediment to proceed with phase two of the rollout with Pfizer," he said.
With the J&J and Pfizer deals, South Africa has enough vaccines for more than 40 million people out of its population of around 60 million. It has also made a downpayment to global vaccine distribution scheme COVAX.
South Africa is the worst-hit country on the African continent for recorded coronavirus infections and deaths, suffering from a more infectious virus variant called 501Y.V2.
The country had planned to kick-off its vaccination campaign in February with AstraZeneca's vaccine. But it put plans to use that shot on hold after a small local trial showed it offered minimal protection against mild to moderate illness from the 501Y.V2 variant.