Which COVID-19 Vaccine Availed Approval for Emergency Use in India?

Thursday February 4, 2021 at 2:15 pm

Following this, the latest COVID 19 vaccine by Oxford, ‘Covishield,’ is about to get approval for its emergency usage in India as per the sources.

The havoc and terror of the recent pandemic and COVID-19 spread await, introducing the most effective Vaccine to save people’s lives. And reports state that soon some of the most significant trials reveal their experimental vaccines, but confirmation from the upper authorities is still due. After repeated trials, one Vaccine is ready for the roll-out this January for emergency use. Indian drug regulatory authorities are eyeing the prospects of the COVID-19 Vaccine by Oxford in the coming week. Before its approval for emergency use in India, Serum Institute is ready to manufacture new shots in Delhi.

Sources further reported that Indian officials are waiting for the U.K. drug regulation to approve the Oxford vaccine by its expert committee. Even CDSCO will hold a meeting to review the immunogenicity and safety data related to the vaccinations. There will be conduction of several clinical evaluations abroad and within the country to grant authorization for its urgent use. However, it is only speculation, and nothing is certain until the details and though papers relevant to the approval are out!

Indian vaccine makers are also following the race!

COVID 19 Vaccine is the need of the world and also for the people within the country. Indian participants are also following the race as they await the emergency approval for Bharat Biotech’s COVID 19 vaccine, i.e., ‘Covaxin.’ However, it might take a considerable amount of time as it is still undergoing several trials phases. Three trials are still left, and Pfizer, on the other hand, is due to give its presentation.

SII Serum Institute of India also came up with additional information relevant to the Drug Controller General of India DCGI. All the data revealed from their end authenticates the approval for a vaccine applicable for emergency use in the country.

New updates amidst multiple trials of the COVID 19 vaccine!

Amidst the worries and fears related to this pandemic, the new mutated variant of SARS-CoV-2 got detected in the U.K. Even the government officials updated the fact that the new virus mutation is not going to affect the trails and approvals of emergency vaccines that are on the go. Hence, the vaccine producer companies in India and abroad are aggressively working under pressure levels to ace initial vaccination providers’ race. After all, the one who first captures the market and provides vaccine supplies can make splurging profits out of it.

As per the latest reports, Bharat Biotech (SII) and Pfizer made an application with the Drug Controller General of India (DGCI) to approve the Vaccine. But considering the seriousness of this situation, authorities are in no hurry to provide the Vaccine’s authorization early this month.

Central Drugs Standard Control Organisation (CDSCO) and Subject expert committee (SEC) further demand additional data on the COVID 19 vaccine by Bharat Biotech. They are under a deep and deliberate approach over the related applications to come up with the right choices. After determining all the aspects, the best vaccination for emergency use in India can get approval.

The Pfizer vaccine from the U.S. Pharmaceutical company is still not considering on the priority list. The company needs some more time to make a presentation in front of the committee. But Pfizer already attained approval in many other countries such as the U.S., U.K., and Bahrain.

What are Bharat Biotech’s chances to qualify as the COVID 19 vaccine for emergency use in India?

While the committee went through the SII application and data details, the SEC recommended them to submit the entire safety data under phase 2 and 3 clinical trials. Further, they would retrieve the immunogenicity data relevant to the clinical trials from India and the U.K. as well. It results from the overall assessment by U.K. medicines in association with the Healthcare products regulatory agency (MHRA).

Bharat Biotech based COVID 19 Vaccine is high on hopes to qualify for the first Vaccine that can prevail a nod for emergency use in India. SII is also the largest vaccine manufacturer globally has its base in Pune. It is planning a collaboration with AstraZeneca and Oxford University to come up with the best Vaccine.

SII is ready with almost 40 million vaccine doses and is stocking the license by DGCI as per their officials. Meanwhile, there is a buzz that COVID 19 vaccine by AstraZeneca got approval for emergency use in India. But it is preferable for usage in collaboration with the alternative shots by the drugmakers.

Health officials from India approved AstraZeneca, and Mr. VG Somani from DGCI stated that this is 110% safe to use. Earlier this Sunday, the Times of India reported this statement by Somani, and people are already excited to avail of the Vaccine shots against this disease at the earliest possible.

Prime Minister of India Narendra Modi stated that it is a decisive fight to stay in high spirits and break the spread of this COVID pandemic. Hopefully, this collaboration of Bharat Biotech’s local drug and the Vaccine by AstraZeneca in association with Oxford university ends the terror of coronavirus in the country.

AstraZeneca’s CEO Adar Poonawalla and Serum Institute of India (SII) would work to increase local production of this drug. ‘Covishield’ might be the new name that hits India’s Pharma market, and people are eager to get its availability and supplies all over!

Concluding facts

This Wednesday, even the U.K. gave a green flag to ‘Covishield’ for emergency use in their country. The company is already working in full swing to accelerate the production rate and manufacture a minimum of 2 million doses each week. Bharat drug’s Covaxin is under Phase 3 trial with over 20,000 volunteers throughout the country. COVID 19 Vaccine will be out first for emergency use by healthcare workers in hospitals and COVID centers from the country.

There are also rumors that the new Vaccine might have side-effects like impotency, which is denied by the officials. Mild fever, allergy, or pain is, however, common after the use of any vaccine. The emergency vaccine announcement can become a boon for the frontline workers combating the COVID-19 disease and standing as victorious warriors in these challenging times!

Releted Blog