The United States Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) have recommended to temporarily suspend the rollout of Johnson & Johnson COVID-19 vaccine.
This followed the reported cases of blood clotting among six recipients of the vaccine in America.
“Of the clots seen in the United States, one case was fatal, and one patient is in critical condition. While we review the available data, out of an abundance of caution, the FDA and CDC are recommending a pause in the use of these vaccines in the United States,” Dr. Peter Marks, director of the US-FDA Center For Biologics Evaluation And Research, said.
Johnson & Johnson said they have already decided to “proactively delay” the rollout of the product in Europe, and assured that the cases are being reviewed with European health authorities.
The company added that there is no sufficient evidence yet to prove that the vaccine causes blood clots. More than 6.8 million doses of the single-dose vaccine have been administered in the US.
“Right now, I’d like to stress these events appear to be extremely rare. However, COVID-19 vaccine safety is a top priority for the federal government. And we take all reports of adverse events following vaccination very seriously,” Dr. Janet Woodcock, acting US-FDA commissioner, said.
Philippine FDA Director-General Eric Domingo said in the Laging Handa briefing on Wednesday that they are currently evaluating the emergency use authorization (EUA) application of Johnson & Johnson.
Domingo said local experts are also looking into the reported “very rare cases of blood clotting” as part of their evaluation.
“Of course, it will probably have recommendations din [too] on how to guide vaccinators at [and] vaccinees to watch out for such events, at saka kung anong gagawin kapag may naramdaman sila [and on what to do in case they feel something],” he said.
“Pumasa rin naman siya sa US at sa WHO [It passed in the US and WHO]. Ibig sabihin [This means], the benefit of the vaccine definitely… outweighs the harm,” he added.
Issue not new
The issue of blood clotting related to COVID-19 vaccines is not new.
On April 8, the Philippine Department of Health (DOH) also temporarily stopped the use of AstraZeneca vaccine for individuals aged 59 and below due to a reported connection of the vaccine with “very rare side effects” of blood clots.
Based on the data in the British Medical Journal 2021, only four per million individuals vaccinated with AstraZeneca have a risk of blood clotting. This is lower than the 1,763 per million individuals at risk of blood clotting due to smoking.
Members of the Philippine’s vaccine experts panel (VEP) said the benefits of vaccines still outweigh their possible risks. – Report from Mark Fetalco/AG -jlo
