Johnson & Johnson Covid-19 vaccine re-approved in the US

The pause on the Johnson & Johnson Covid-19 vaccine was officially lifted in the US yesterday by the Centre For Disease Control And Prevention and the US Food And Drug Administration. They will add a warning label about the risk of blood clots, but vaccination can resume today.

The CDC’s Advisory Committee For Immunization Practices recommended unpausing the Johnson & Johnson vaccine, saying that the benefits outweigh the minimal potential risks. The jab has already been approved for use in Thailand.

The CDC considered several models of possible effects from putting the Johnson & Johnson Covid-19 vaccine back into circulation. They predict 26 to 45 TTS cases but a prevention of 600 to 1,400 Covid-19 deaths and up to 3,500 ICU patients avoided. They believe the vaccine will meet all quality and safety standards and that nervous patience should speak with their healthcare provider.

The CDC director said that she supports the use of the Johnson & Johnson Covid-19 jab for anyone 18 years or older under the FDA emergency use authorisation. Removing 1 of the 3 vaccines Americans are now receiving would slow immunization and herd immunity against Covid-19. Unlike Moderna and Pfizer vaccines, which have not been linked with any blood clots, the Johnson & Johnson jab doesn’t need to be stored in freezing temperatures and is the only 1-shot vaccine, which encourages people that don’t want 2 vaccine appointments.

Blood clots were determined to be exceedingly rare with only 15 possible cases of a rare condition called thrombosis with thrombocytopenia syndrome, and only three deaths amongst people who receive the Johnson & Johnson Covid-19 vaccine. The CDC schedule a phone briefing for medical personnel to discuss the decision and go over symptoms and treatment for TTS. Severe headaches days or weeks after getting the vaccine are the main warning signs.

TTS is an extremely rare type of blood clot that involves an unusual targeting of platelets as your body’s immune system reacts. Antibodies stop the platelets from circulating which causes clotting. An immune product called IVIG can regulate antibodies as treatment, and blood thinners are often helpful as well.

Comparing the half-million deaths in the United States from Covid-19 to the risk of the vaccine causing blood clots, we can analyse several demographics. In 1 million women aged 18 to 49 years old, the Johnson & Johnson Covid-19 vaccine could prevent 12 deaths and over 650 hospitalizations, while the risk of blood clot for that same group is just 7 cases. In a group of 1 million women over 50, nearly 600 deaths and more than 4,700 hospitalizations could be prevented by the vaccine, with the possibility of less than 1 blood clot statistically. As of yet, there haven’t been any blood clot cases amongst men.

Another often overlooked statistic is that while the Johnson & Johnson Covid-19 vaccine carries a low risk of blood clots at just 1.9 cases per million people, Covid-19 itself is a much much bigger cause of blood clots with about 147,000 per million hospitalized Covid-19 patients having blood clots.

The data shows that the blood clots issue is extremely rare, and the positive impact of the Johnson & Johnson jab far outweighs the obscure risk. The ACIP decided against more complicated restrictions for the Johnson & Johnson Covid-19 vaccine mostly based on gender. In the end, they ruled it was suitable for anyone over 18 years old, though 4 members of the committee objected.

The Food And Drug Administration updated their Johnson & Johnson fact sheet for use at vaccination sites, mentioning the minimal blood clot risk in women under 50. Johnson & Johnson themselves had agreed to reword the label to mention TTS. The American Medical Association agreed to disseminate information as well.

SOURCE:CNN