An expert panel from India’s central drug authority on Saturday recommended granting permission for the restricted use of the indigenous COVID-19 vaccine developed by Bharat Biotech Covaxin in an emergency situation, especially in the context of infection by mutant strains, authorities said.
The recommendation for the Bharat Biotech vaccine came one day after the panel. approved the application for emergency use authorization from the Serum Institute of India for Oxford-AstraZeneca’s Covishield vaccine, paving the way for the deployment of COVID-19 injections in the country in the coming days.
The Union Ministry of Health also confirmed on Saturday that the Subject Matter Expert Committee (SEC) of the Central Organization for the Control of Standard Medicines (CDSCO) recommended granting permission to the Serum Institute of Institute (SII) for emergency restricted use Covishield in India, subject to multiple regulatory conditionalities.
“The SEC of CDSCO met on January 1 and 2 and formulated recommendations for the consideration and final decision of the Comptroller General of Drugs of India (DCGI),” the ministry said.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR).
The SEC again deliberated on Bharat Biotech’s Emergency Use Authorization (USA) request on Saturday after it submitted updated data, rationale, and requested consideration of its proposal in light of the incidence of a new mutated coronavirus infection. .
It recommended “granting permission for restricted use in emergency situations of public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains, to Bharat Biotech”, stated the Ministry of Health.
However, according to the sources, the committee stated that the company will continue the ongoing phase 3 clinical trial and will send the data arising from the trial when available.
The committee noted that the vaccine is an inactivated full-virion coronavirus vaccine, which has the potential to target mutated coronavirus strains, a source said. The data generated so far demonstrate a strong immune response (both antibody and T-cell) and viral neutralization in vitro.
While granting emergency restricted-use approval for Oxford’s COVID-19 vaccine on Friday, the panel had imposed certain regulatory provisions, including that the injection is indicated for active immunization in people 18 years of age and older to prevent the disease and that IBS should submit safety, efficacy, and immunogenicity data from ongoing clinical trials in the country and around the world for review as soon as possible.
In addition, the Pune-based company is required to submit safety data, including data on post-vaccination adverse events (AEFI) and adverse events of special interest (AESI) with due analysis every 15 days for the first two months and then monthly until the end of the ongoing clinical trial in the country, in accordance with the recommendations.
Thereafter, the company must submit the safety data in accordance with the provisions and standard procedures.
According to the sources, the recommendations indicated that the vaccine should be given along with a fact sheet and a separate leaflet for the guidance of the healthcare provider. The Serum Institute of India, the world’s largest vaccine manufacturer, has partnered with AstraZeneca to manufacture Covishield.
According to sources, the company had submitted details of the conditions and restrictions under which AstraZeneca was granted the UK emergency use authorization and the revised fact sheet and prescribing information in the Indian context, such as required by committee.
On December 6, SII had applied to the Comptroller General of Drugs of India (DCGI) USA for the COVID-19 vaccine from Oxford on December 6, while Hyderabad-based Bharat Biotech had applied for the go-ahead for its Covaxin. developed locally on December 7.
Pfizer had applied for regulatory approval for its vaccine on December 4 and it has yet to be discussed. After detailed deliberations, the SEC also recommended the granting of permission to Cadila Healthcare Ltd in Ahmedabad to conduct the phase 3 clinical trial protocol for its candidate vaccine.
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