The Expert Committee appointed by the Central Pharmaceutical Standards Control Organization has recommended a limited level of emergency use for Covaxin of Bharat Biotech.
In relation to the indigenous Covid-19 vaccine candidate in India, the Subject Expert Committee appointed on behalf of the country’s Drug-Watch Central Drug Standards Control Organization (CDSCO) recommends that it may be of limited emergency use, However, this permission is granted without releasing any efficacy data.
Officials told that the approval of the Subject Expert Committee meant that covaxin could be included in the government’s vaccination campaign until any incident of adverse reaction occurred within a set period of time after vaccination. The Central Drugs Standard Control Organization had entrusted the responsibility of the government to advise and give its recommendations regarding Covid-19 vaccines.
The vaccine, produced by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology, Pune, has been in controversy many times since the human trials began on June 29, and the latest recommendation for emergency use is.
All the information you need to know about Covaxin – from how it works to the controversies associated with it.
How does it work
Covaxin is made from an inactivated vaccine, which means that the vaccine is made from a virus that has been killed and which can no longer cause infection. When injected into the body, the immune cells can recognize the virus even when it is inactive, and an immune response is activated.
This vaccine was created by NIV, Pune by isolating an Indian strain of the virus.
Trial results so far
On December 22, Bharat Biotech released the data for the second phase trial on a non-peer reviewed website along with the follow-up to its first phase trial.
Data indicate that the vaccine is safe, with no serious adverse effects observed. The study also included the ‘hypothesis’ that the T-cell and B-cell immune responses caused by the vaccine’ may persist for at least 6 to 12 months after the second dose of vaccination. “
The study also said that the third phase of the trial would need to be done on a wider scale to evaluate the results of safety.
Bharat Biotech was allowed to conduct a third phase trial on October 23 at 25,800 volunteers – becoming the largest ever test of efficacy in the country.
On 22 December, the company announced that it had crossed the halfway mark after recruiting more than 13,000 volunteers.
Conflict
Controversy erupted on July 2 when a letter with the signature of ICMR chief Balram Bhargava appeared. In the letter, he had asked the principal investigators to complete all phases of the trial with the aim of launching the vaccine by 15 August.
Later denying any deadline was set, ICMR said, ‘Our internal correspondence was misunderstood. We only said that we hope to have the vaccine available by August 15 and this is not a deadline.
The Print reported in a report published on December 28 that Bharat Biotech advised the principal investigators to encourage volunteers to enroll by stating that the Phase III trial would give them immunity against Covid-19.
In a document sent by the government to the principal investigators, it said, “It may take several months for people over 50 years of age to apply the Covid-19 vaccine.” It has also been added, ‘Therefore, it would be appropriate to participate in the efficacy of the third phase of covaxin and get vaccinated to protect yourself from Covid-19.’
The SEC recommended on Saturday that the vaccine be limited to emergency use despite efficacy data not being released – this means that no data has been in the public domain until now, including interim analyzes proving the vaccine’s efficacy,
Bharat Biotech first applied for the EUA on 7 December, and then a government expert panel appointed by the Drug Controller General of India asked for additional data related to the various Phase III trials.
