MANILA, Philippines — The Philippine government will consider reported cases of “rare” blood clotting among people vaccinated with Janssen Pharmaceuticals’ COVID-19 jab in its deliberations on the drug maker’s emergency use authorization (EUA) application.
According to Department of Health (DOH) Undersecretary Maria Rosario Vergeire, the Belgium-based pharma owned by the US company Johnson & Johnson (J&J) has to submit to the country’s Food and Drug Administration (FDA) all studies related to its clinical trials of the vaccine.
This comes after the United States and South Africa temporarily suspended the administration of the Janssen COVID-19 jab amid reported blood clots among recipients. J&J has also delayed the rollout of its vaccine in Europe.
“In the case of the Philippines, nag-a-apply sila sa FDA, kailangan isasubmit din nila sa atin ‘yung pag-aaral na ginawa nila base doon sa mga nangyari sa clinical trials nila,” she said in an online press briefing.
(In the case of the Philippines, they are applying before the FDA, they have to submit studies they have conducted based on what happened during their clinical trials.)
“That would be part of the recommendation or evaluation of the Food and Drug Administration and our Vaccine Expert Panel kung sakaling nangyari nga ‘yan (blood clotting) at kung ano ang kanilang irerekomenda base sa EUA na inaaplyan ng Janssen,” she added.
(If such incidents on blood clotting indeed happened, that would be part of the recommendation or evaluation of the FDA and our Vaccine Expert Panel on the EUA that Janssen is applying for.)
DOH’s statement in the issue also comes a day after vaccine czar Carlito Galvez Jr. said the government is expecting to sign this week a supply agreement with J&J for six million doses of its single-shot COVID-19 jab.
J&J earlier said it is aware of an “extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received [its] COVID-19 vaccine.”
It added that the US Centers for Disease Control and FDA are reviewing data involving six reported US cases out of more than 6.8 million vaccine doses that were administered.
J&J also said it is reviewing these cases with European health authorities and have been working closely with medical experts.
Janssen applied for EUA of its COVID-19 vaccine before the Philippines‘ FDA on March 31.