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COVID-19 Vaccine Updates
With input from Dr Monica Vasudev
1560: CDC and FDA recommend halt to use of Johnson & Johnson COVID-19 vaccine in US over blood clot concerns
The US CDC and US FDA recommend pause to Johnson & Johnson COVID-19 vaccine use over six reported cases of a rare, severe type of blood clot in the US.
The six reported cases are among over 6.8 million doses of the vaccine administered in the country. All six cases have been noted among women aged 18 to 48 years, and the symptoms developed 6 to 13 days following vaccination, revealed a joint statement from the CDC and the FDA.
Johnson & Johnson issued a statement that the company will proactively delay the rollout of its vaccine in Europe.
For individuals who have been administered the J&J vaccine, those who have developed severe headache, abdominal pain, leg pain or shortness of breath within three weeks of vaccination must contact their healthcare provider, noted the statement.
Dr. Carlos del Rio, executive associate dean of the Emory University School of Medicine at Grady Health System said that it is a very rare event; about 1 in a million, adding that blood clotting is probably associated with the fact that the J&J vaccine is an adenovirus vector vaccine, like the AstraZeneca vaccine.
The AstraZeneca vaccine is not being used in the US, but has been authorized in over 70 countries. The European Medicines Agency recently stated that unusual blood clots with low blood platelet levels should be listed as very rare side effects of the AstraZeneca COVID-19 vaccine. While the regulators advised people to look out for the signs of clots, they emphasized that the benefits of the vaccine outweigh the risk. (CNN)
CDC and FDA Issued Joint Statement on Johnson & Johnson COVID-19 Vaccine
The U.S. CDC and FDA have issued a joint statement on Johnson & Johnson COVID-19 vaccine stating that as of April 12, over 6.8 million doses of the vaccine have been administered in the U.S. The agencies are looking into data on six reported cases of a rare, severe blood clot after receiving the J&J vaccine in the U.S.
In these cases, cerebral venous sinus thrombosis (CVST) was observed in association with low levels of blood platelets. All six cases were noted among women aged 18 to 48 years, and symptoms appeared 6 to 13 days following vaccination.
Treatment of this specific type of blood clot varies from the treatment usually administered. Heparin is usually given to treat blood clots. However, in this setting, heparin may be harmful, and alternative treatments are required.
The CDC is set to conduct a meeting of the Advisory Committee on Immunization Practices (ACIP) to review these cases and the FDA will review the analysis. Until then, the use of this vaccine has been paused. This is vital, partly, to make sure that the healthcare providers are aware of the potential for these adverse events and can plan for identification and management owing to the specific treatment required with these blood clots.
At present, these adverse events seem to be very rare. People who have already received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of vaccination have been advised to contact their healthcare provider. Healthcare providers must report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.(CDC)
Dr KK Aggarwal
President CMAAO, HCFI and Past National President IMA