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Top panel expands Covishield, Covaxin reviews to look for possible danger signals




The government is on the alert due to international concerns that AstraZeneca’s Covid vaccine is associated with a rare blood clot. The Indian Supreme Commission on Post-Vaccination Side Effects is expanding the review of data related to Covishield and post-vaccination side effects. Kovacin To understand if there is a similar danger signal.

The development, following instructions from the European Pharmacy (EMA) on Wednesday, cited abnormally low platelets (platelet hypoplasia) and “abnormal” thrombosis (thrombosis) as “very rare” side effects of the AstraZeneca vaccine. I am. The EMA Safety Commission (PRAC) states that these rare types of blood clots occur “occasionally” with low levels of platelets in “abnormal” sites such as the brain (CVST), abdomen (SVT), and arteries. I found. ,bleeding.

A similar review of those vaccinated in the United Kingdom prompted regulators (MHRA) to revise their recommendations for this vaccine. This vaccine is produced in India by the Serum Institute of India under the brand “Covishield”.

“Indian regulators need to provide data on similar adverse events noted in India,” said Dr. Slinato Lady of the Indian Public Health Foundation. In India, the National Commission on Post-vaccination Adverse Events (AEFI) has expanded the review of adverse reactions reported after vaccination in priority groups, covering approximately 19,500 mild cases. The latest review reviews cases of thrombocytopenia found in more than 400 previous reviews of severe and severe AEFI.

The review is expected to continue until next week, subject to anonymity. “We are in control of what EMA and UKMHRA are saying,” sources said. India Express.. “We want to see if there are similar concerns (with respect to the vaccines used in our program),” he said, saying the review will “specifically” focus on the issue of blood clots “in the vaccine.” Added.

“In a preliminary review, cases of thrombocytopenia were found in some people,” sources said, and these cases were “very few” in the severe and severe AEFI cases previously reviewed. I added that. “The causal link to the vaccine (in these cases of thrombocytopenia) has been elucidated … everything is done in a rigorous scientific way,” he added.

Decisions such as whether to publish recommendations similar to the UK MHRA and EMA will be made after the review. “If you need to give advice, it will be given,” the source said.

However, he said the issue also needs to be addressed “carefully” so that most of the vaccines stockpiled for vaccination do not raise alerts in India, which is a covishield. “In these other countries, there are more options like the Pfizer-BioNTech vaccine, so it’s much easier to provide an alternative,” he said.

SII declined to comment on the development, but inquiries to Bharat Biotech, the creator of Covaxin, were not answered by Thursday’s press time.

So far, Indian reviews have not found a source of concern about Covishield or Covaxin. About five people under the age of 70 died of myocardial infarction (heart attack) in the country after vaccination, according to a PRAC report on March 24, but the government said these deaths were “unrelated to the vaccine.” I decided. It studied international AEFI data.

“Given that India is receiving more Covishield than the EU or UK AstraZeneca vaccine, the government has chosen not to share serious AEFI details, so far in India as well. Rare adverse events can occur, but are rarely investigated, “said Malini Aisola, co-combiner of the patient activist group All India Drug Action Network (AIDAN).

“There is strong evidence that the evidence collected at the district level can be weak and inadequate and can undermine higher-level reviews by the National AEFI Commission. For many deaths, after death Not done, and local governments tend to immediately dismiss a causal link to the vaccine, even before the district’s investigation is complete, “she said.

According to Aisola, the government has published 13 hospitalization and mortality findings to date, suggesting a “huge” backlog of AEFI cases to be considered by the Commission. The information provided in the public domain represents “a small part” of the hundreds of severe and severe AEFIs reported so far and has potential associated with vaccines used in national vaccination programs. It does not clearly indicate if there is a problem. Added.


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