With COVID-19 cases, as well as deaths, increasing with each passing day, a vaccine against the deadly virus seems to be the only solution to contain the pandemic. While there are several vaccine candidates that are at various stages of clinical trials, some of them have shown promising results with an efficacy of over 90 per cent. Now, India is in talks with US-based biotechnology company Moderna after the company claimed that its COVID-19 vaccine candidate has shown efficacy of 94.5 per cent.
Moderna had on Monday claimed that the independent National Institutes of Health-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, found the vaccine to have an efficacy of 94.5 percent.
“We are in dialogue not only with Moderna, but also with Pfizer, Serum Institute, Bharat Biotech and Zydus Cadila over the progress of the clinical trials of each of the vaccine candidates and where their vaccines stand in terms safety, immunogenicity and efficacy, and regulatory approvals,” a source was quoted as saying by a news agency.
The New Drugs and Cosmetics Rules, 2019, provides that any new drug or vaccine which has been tested and got regulatory approval outside India will have to undergo bridging phase 2 and 3 clinical studies for its secure regulatory approval in India.
“As per law, the CDSCO, under the New Drugs and Cosmetics Rule 2019, can omit, relax or abbreviate the regulatory requirement or conditions of submitting pharmaceutical and clinical data of a vaccine candidate in Indian population in case of any emergency or pandemic like situation,” the source told the news agency.
Pfizer claimed its vaccine has efficacy of over 90%
Cambridge, Massachusetts-based Moderna’s announcement comes just a week after Pfizer and Biontech said their COVID-19 vaccine candidate was found to be more than 90 percent effective in preventing COVID-19 in participants.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible,” said Stéphane Bancel, chief executive officer of Moderna.
“This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent Covid-19 disease, including severe disease,” he said.
Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorisation (EUA) with the US Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least 2 months).
Moderna also plans to submit applications for authorisations to global regulatory agencies.
Pfizer plans to produce 50 million vaccine doses in 2020
Based on the efficacy data generated from the clinical trial, Pfizer and BioNTech had officially announced that they are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.
Based on current projections, the companies expected to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
India’s COVID-19 case tally nearing 90 lakh
The health ministry on Tuesday informed that 29,163 fresh cases of COVID-19 have been reported in India in the past 24 hours. The addition of the fresh cases has taken the COVID-19 case tally to 88.74 lakh.
This is the first time in over four months that the daily surge in COVID-19 cases has fallen below 30,000.
So far, the biggest single-day surge of 97,894 COVID-19 cases was reported in India on September 17. The second-highest surge of 97,570 COVID-19 cases was recorded on September 12. It is followed by 96,551 cases reported on September 11.
Notably, India has already surpassed Brazil in terms of cases. It is now the second-worst hit nation due to the coronavirus pandemic after the US.
1.30 lakh deaths due to COVID-19
Also, 449 COVID-19 related deaths were reported by the ministry during this period. The addition of the fresh fatalities has taken India’s death toll due to the deadly virus to 1,30,519.
Previously, the death toll had crossed the 1,200-mark on September 16.
Similarly, the biggest surge of over 97,894 cases was reported on September 17.
88.74 lakh patients recovered
Of the 88.74 lakh coronavirus cases reported so far, over 4.53 lakh are active cases of the virus. It is above 5 per cent of the total caseload. Interestingly, 82.90 lakh cases have recovered from the viral infection so far.
To read the latest news in Gujarati click here