Updated: November 24, 2020 7:31:52 am
It comes as the UK government introduced new laws on Friday that would allow greater numbers of healthcare workers to administer flu and potential COVID-19 vaccines. (Photo: REUTERS / Archive)
Oxford-AstraZeneca announced Monday that interim trial data from crucial Phase 3 trials has shown that its Covid-19 vaccine candidate is 70.4 percent effective, indicating a high level of protection against infection with the new coronavirus.
In Pune, Dr. Cyrus Poonawalla, founder of the Serum Institute of India (SII), which is testing and manufacturing the candidate under license, said the vaccine would be available in India “very soon”.
“A vaccine against coronavirus disease will be available in our country very soon. We are going to apply for a special emergency marketing authorization within 45 days from today, ”the 79-year-old president of Poonawalla Group told The Indian Express.
Scientists at the University of Oxford and the British-Swedish pharmaceutical giant AstraZeneca made three major announcements about the “highly effective” vaccine candidate, AZD1222: first, two different dosing regimens had shown efficacy, and one showed a better profile; second, the candidate met the primary endpoint of efficacy in preventing infection; Third, no hospitalizations or severe cases of Covid-19 were reported in participants who received the candidate vaccine.
“An independent Data Safety Monitoring Board determined that the analysis met its primary endpoint showing that protection against Covid-19 occurs 14 days or more after receiving two doses of the vaccine. No serious vaccine-related safety events have been confirmed. AZD1222 was well tolerated in both dosing regimens, ”AstraZeneca said in a statement.
The interim analysis, which included 131 Covid-19 patients, indicates that one dosing regimen showed 90 percent efficacy when the vaccine was administered as a half dose followed by a full dose at least one month apart; another regimen was 62 percent effective when given in two full doses at least a month apart.
“Combined analysis of both dosing regimens resulted in an average efficacy of 70 percent. All the results were statistically significant. More data will continue to accumulate and further analysis will be conducted, refining the efficacy reading and establishing the duration of protection, ”the statement said.
The pooled analysis included data from the phase 2/3 trial in the UK and the phase 3 trial in Brazil. More than 23,000 participants are being evaluated following two doses of a half dose / full dose regimen or a two full dose regimen of AZD1222 or a comparator (MenACWY).
The University of Oxford said it will now support AstraZeneca in submitting interim Phase 3 efficacy data and extensive safety data to all regulators “around the world, including the UK, Europe and Brazil for independent scrutiny. and product approval, including for emergency use. ” . In addition, the statement said that “the company will seek a World Health Organization Emergency Use List to accelerate the path to vaccine availability in low-income countries.”
Poonawalla told The Indian Express that “40 million doses (of the candidate vaccine) have already been produced and we should definitely be able to produce another 60 million doses in a minimum of 45 to 60 days.”
Following the announcement of the trial results by Oxford, IBS Executive Director Adar Poonawalla tweeted that he was “delighted to learn that Covishield, a low-cost, logistically manageable and soon to be widely available Covid-19 vaccine, it will offer protection up to 90 percent in one type of dosage regimen and 62 percent in the other dosage regimen. “
Covishield is the name of the AZD1222 candidate in India. IBS, which was founded by Poonawalla in 1966 and is now the world’s largest vaccine manufacturer by dose, has multiple Covid-19 vaccine partnerships and is conducting the Indian trials of the Oxford-AstraZeneca candidate.
The emergency authorization for the vaccine by the Indian regulator will be the first step in ensuring its administration based on a list of priorities, starting with front-line healthcare workers.
IBS scientists, in fact, are hopeful that they can launch the vaccine before the year is out. Poonawalla said: “We hope that the government will give the go-ahead to vaccinate those most at risk: doctors, nurses and health workers in hospitals.” In anticipation of receiving regulatory authorization, 100 million doses will be ready through a special license in a month and a half, he said.
Oxford-AstraZeneca has announced interim data from phase 3 days after results from the phase 2 peer-reviewed trial showed that the vaccine induces strong antibody and T-cell immune responses in all age groups, including adults. older, and has been shown to be safe. and well tolerated.
Professor Andrew Pollard, chief investigator of the Oxford Vaccine Trial in Oxford, said: “These findings show that we have an effective vaccine that will save many lives. Interestingly, we have found that one of our dosing regimens can be around 90% effective and if this dosing regimen is used, more people could be vaccinated with the planned vaccine supply. Today’s announcement is only made possible by the many volunteers in our trial and the talented and hardworking team of researchers from around the world. “
In IBS, at least 350 people are involved 24 hours a day, 7 days a week in the production of the vaccine. Several countries are interested in the Oxford candidate, which is based on proven technology and intended to be cheaper than Moderna and Pfizer’s mRNA vaccines. In a previous interaction with the media, the IBS leadership had said that the vaccine could be priced at a maximum of Rs 1,000 for two doses needed by the public.
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