FDA: Local experts discussing blood clot concerns over Johnson & Johnson COVID-19 vaccine
MANILA, Philippines — Vaccine experts in the Philippines are discussing reports of extremely rare blood clots that emerged in six recipients of the Johnson & Johnson COVID-19 jab in the United States, the country’s Food and Drug Administration said Wednesday.
US health authorities recommended the pause on the rollout of Johnson & Johnson’s single-dose COVID-19 vaccines due to blood clot concerns. The pharmaceutical firm announced it will delay the rollout of its jab in Europe.
In a briefing Wednesday, FDA Director General Eric Domingo said local vaccine experts are discussing reported cases of a rare type of blood clot disorder. The agency is hoping to receive the experts’ recommendation on Thursday.
“If their evaluation is done and they have recommendations, of course, we’ll also probably have recommendations on how to guide vaccinators and vaccinees to watch out for such events and what they should do if they experience something,” Domingo said in a mix of English and Filipino.
In a separate briefing, Health Undersecretary Maria Rosario Vergeire said vaccine manufacturers have the responsibility to report such incidents to the local drug regulator.
“That will be part of the recommendation or evaluation of the FDA and our VEP — if such incidents indeed happen — on the EUA that Janssen is applying for,” Vergeire said in Filipino.
Janssen Pharmaceutica, a division of Johnson & Johnson based in Belgium, is developing the vaccine.
Last month, Johnson & Johnson asked the FDA to authorize its one-shot coronavirus vaccine for emergency use in the Philippines. The World Health Organization added the J&J jab to the list of safe and effective emergency tools against COVID-19.
Once authorized by the local regulator, it will be the fifth vaccine maker to get an emergency use authorization in the country, following Pfizer-BioNTec, AstraZeneca, Sinovac and Gamaleya Research Institute.
Extremely rare
The US Food and Drug Administration and the Centers for Disease Control recommended a pause in the use of J&J vaccine “out of abundance of caution” while a review of reports of rare blood clots is conducted.
Officials said out of nearly seven million Americans who have so far received the single-dose shot, six women between age 18 and 48 developed a rare type of clot in the brain along with low platelets.
One person later died, while another is in critical condition.
The disorder appeared similar to that observed in rare cases of people who received the vaccine developed by AstraZeneca in Europe. The COVID-19 shots of Johnson & Johnson and AstraZeneca are based on adenovirus vector technology.
Last week, Philippine health authorities said the use of AstraZeneca vaccines for individuals aged below 60 years old follow was temporarily suspended. But Domingo said Wednesday that the World Health Organization and local vaccine experts said the benefits of using the jab still outweigh potential risks.
The J&J jab received praise for its single dosage and because it does not need to be kept in subarctic temperatures unlike the COVID-19 shots from Pfizer and Moderna, making distribution simpler.
Global clinical trials of almost 40,000 people showed the one-shot coronavirus vaccine was 85.4% in preventing severe disease but the efficacy fell to 66.1% when including moderate forms of the disease.
Last month, vaccine czar Carlito Galvez said the country was hoping to finalize the supply agreement to secure vaccines developed by Johnson & Johnson. — with a report from Agence France-Presse
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