Marking the formal beginning of the evaluation process for Covid-19 vaccine candidates who have applied for emergency clearance in India, the Central Organization for Standard Medicines decided to seek additional safety and efficacy data from the Serum Institute of India and Bharat Biotech before giving the approval. Pfizer’s request was not discussed Wednesday because the company was looking for more time.
Here are the latest updates:
1. The Center will begin shipping additional cold storage kits to union states and territories starting tomorrow, as its preparation for the vaccination campaign has already begun.
2. Serum Institute of India will now have to submit updated safety data from phases 2 and 3 of clinical trials in the country. The expert committee has also sought the immunogenicity data from the UK clinical trial together with the UK regulator’s assessment prior to granting authorization.
3. Bharat Biotech must submit the safety and efficacy data from the ongoing phase 3 clinical trial in the country.
Four. The Comptroller General of Medicines of India (DCGI) has granted conditional approval for phase 1 and 2 clinical trials of India’s first Covid-19 mRNA vaccine candidate, HGCO19, which is being developed by Gennova Biopharmaceuticals.
5. Pfizer has said that it will have differentiated prices on its COVID-19 vaccine for different countries, as the company aims to make the vaccine available worldwide.
6. Britain’s drug regulator has warned that people with a history of major allergic reactions should not receive Pfizer-BioNTech’s Covid-19 vaccine after two people reported adverse effects on the first day of implementation.
7. However, it is not yet a cause for concern, scientists have said. Many people may be sensitive to the ingredients in the injection, such as gelatin or egg protein, or to the vaccine itself. People with an egg allergy are sometimes advised not to get a flu shot, since that vaccine is grown primarily in chicken eggs, experts said.
8. The Pentagon will begin small-scale Covid-19 vaccines at 16 defense sites in the United States and abroad.
9. Israel will begin vaccinating its people on December 27. You have received the first shipment of doses of the Pfizer vaccine.
10. Canada’s health regulator approved Pfizer’s Covid-19 vaccine on Wednesday. It will receive up to 249,000 doses this month and 4 million doses of the vaccine in March.
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