– FDA’s restriction is just a precaution, says Health Minister

THE United States Food and Drug Administration (FDA) on Thursday issued a new update limiting the authorised use of the Johnson and Johnson COVID-19 vaccine, but Guyana’s Minister of Health Dr. Frank Anthony has since said there is no reason for worry among locals.

Dr. Anthony spoke about this recent development during his COVID-19 update on Friday, saying that the update came about after the US recorded a few cases where persons died from complications after being inoculated with the vaccine.

He said that the FDA had noticed that with the J&J vaccine, there were a number of cases of blood clotting, which was first detected in 2021, and as a result of that, they had placed a pause on the use of the vaccine in April 2021, which was subsequently lifted.

He then stated, “But I think what prompted their decision now is that they have recorded in the United States at least nine persons who have died in the first quarter of this year after receiving the J&J vaccine, and those persons had complications of thrombocytopenia.”

According to the Mayo Clinic, thrombocytopenia is a condition in which persons have a low blood platelet count. Platelets are blood cells that help blood clot and stop bleeding by forming plugs in blood vessel injuries.
To this end, he noted that this condition, after being vaccinated is a very rare occurrence that happens in about 3.25 cases for every one million doses administered.

He added: “It’s very rare, nevertheless, the FDA in the USA has decided to take these precautions, because they have other vaccines available, namely, the Pfizer mRNA vaccine and the Moderna vaccine, so that’s why they have changed their recommendations.”

Meanwhile, in the case of Guyana, the health minister reported that while the Johnson & Johnson vaccine has been used here, there were no reported cases of the condition, and as such authorities have still been using it.
The minister reiterated that there has been no adverse effect, and persons who have received the vaccines should not panic.

“If you have received the vaccine and you had no complications, then you wouldn’t have any complications now. Generally, after vaccination, you would see thrombocytopenia developing in about a week, two weeks after the vaccination, so, if you have had the vaccine and nothing happened, then you are not in danger,” Dr Anthony said, while adding that this is just a precautionary recommendation that has been made in the United States.

In the FDA’s news release that was issued on Thursday, it stated that the administration has limited the use of the vaccine to individuals 18 years of age and older for whom other authorised or approved COVID-19 vaccines are not accessible or clinically appropriate.

The report further stated that after conducting evaluations and investigations of reported cases, it has determined that the risk of thrombosis with thrombocytopenia syndrome (a rare syndrome where blood clots in combination with low levels of blood platelets, occur simultaneously) occur one to two weeks following the administration of the J&J vaccine.

However, the administration has determined that the known potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks for individuals 18 years of age and older.

The news release quoted the Director for FDA’s Centre for Biologics Evaluation and Research, Dr Peter Marks as saying, “We recognise that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. Our action reflects our updated analysis of the risk of TTS following administration of this vaccine, and limits the use of the vaccine to certain individuals.”