Updated: November 10, 2020 3:43:25 pm
The company’s first interim efficacy analysis indicates that the vaccine may demonstrate efficacy against Covid-19. (Reuters)
The American pharmaceutical company Pfizer has launched preliminary data from late-stage human trials of the Covid-19 vaccine he developed with German biotech company BioNTech. The vaccine has been found to be more than 90% effective. The findings are critical, as the vaccine will undergo a review by the U.S. Food and Drug Administration (FDA) later this month, and talks about the emergency clearance injection are closer. of reality.
What type of vaccine have Pfizer and BioNTech developed?
This is a vaccine that was developed using mRNA technology – it uses messenger RNA molecules that tell cells which proteins to build. The mRNA, in this case, is encoded to tell cells to recreate the spike protein of the new coronavirus. Once the mRNA is injected into the body, the cells will use its instructions, creating copies of the spike protein, which in turn is expected to prompt immune cells to create antibodies to fight it.
Unlike other candidate vaccines, mRNA vaccines are developed synthetically – they don’t need the virus to be grown and replicated, just the code for the most crucial part that the body’s immune system needs to target. Another advantage is that they can be manufactured on a large scale in large tanks called bioreactors.
These are platforms that can work “on demand,” said an Indian vaccine manufacturer who spoke to The Indian Express on condition of anonymity. After obtaining the virus code, it is possible to develop the vaccine in a matter of weeks for preclinical testing, compared with the months required for more traditional platforms.
What do the first results say?
The company’s first interim efficacy analysis indicates that the vaccine may demonstrate efficacy against Covid-19. Based on the findings, the vaccine was “more than” 90% effective in preventing Covid-19 among participants who had received a second dose compared to participants who had only received a placebo.
The firm also said analysis of the data from the last stage of the trial showed there were no serious safety concerns.
Considering that the US FDA, as well as several international regulators and health organizations have suggested that a Covid-19 vaccine should be capable of protecting at least 50% of those who receive it, the findings in the case from Pfizer and BioNTech look promising. 📣 Express Explained is now on Telegram
“The results show that our mRNA-based vaccine can help prevent Covid-19 in the majority of people who receive it. This means that we are one step closer to providing people around the world with a much-needed breakthrough to help end this global pandemic, ”said Albert Bourla, CEO of Pfizer, in a statement on the release of the results.
“This is a first, but critical, step as we continue our work to provide a safe and effective vaccine,” Bourla said.
Phase 3 trials of this candidate vaccine, BNT162b2, began on July 27 and has so far enrolled 43,538 participants, 38,955 of whom had received a second dose as of November 8.
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Does this mean the vaccine will receive emergency approval in the US?
Not necessarily. Interim results released today were for just 94 of the nearly 40,000 volunteers who were injected with the candidate vaccine. “It is important to note that we cannot request FDA Emergency Use Authorization based solely on these efficacy results. More data on safety is also needed, and we continue to accumulate that data as part of our ongoing clinical study, ”said Bourla.
Pfizer and BioNTech are currently accumulating this additional safety data and estimate that it will take until the third week of November for the company to make the safety data available for two months after the second and final dose of the vaccine. Given that this is the amount of safety data specified by the US FDA in its guidance for possible emergency use authorization, it is likely that companies will be able to approach the regulator for emergency approval at that time.
Another mRNA candidate, from the American firm Moderna in collaboration with the National Institute of Allergy and Infectious Diseases, has also been a pioneer in the race for an Emergency Use Authorization from the United States FDA. The firm also expects the required reading of the late-stage human trials later this month and may reportedly approach the regulator for a US by the end of November.
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Will India have access to this vaccine?
Not until now. So far, companies have signed deals for hundreds of millions of doses of the vaccine with countries such as the US, UK, Japan and the European Union region.
According to current projections, the companies expect to produce globally up to 50 million doses of vaccines in 2020 and up to 1.3 billion doses in 2021. While the Indian government had held a “kickoff meeting” with representatives of Pfizer’s Indian subsidiary in late August after early phase 1 vaccine data had come out, there has been no major movement on that front since.
The launch of this Covid-19 vaccine in India would depend on whether Pfizer and BioNTech, either on their own or through a partnership with another Indian vaccine company, approach the Indian drug regulator (Central Drugs Standard Control Organization) to obtain human testing approvals for the candidate here.
Under Indian regulatory requirements, a vaccine should undergo local testing in the country before it can receive approval for release.
India is primarily focused on five other Covid-19 candidate vaccines, which are being tested by the Serum Institute of India, Bharat Biotech, Zydus Cadila, Dr Reddy’s Laboratories, and Biological E.
What major obstacles could prevent a rapid roll-out of this vaccine?
The vaccine may have logistical problems due to cold storage; The candidate is reported to be stored at temperatures below -90 ° F. This would require an ultra-cold storage system, as storing it at refrigerated temperatures, reportedly, for more than two days, can render it ineffective.
This means significant limitations on storage and distribution in countries like India, which is still mapping and expanding its cold storage footprint to even store vaccines at refrigerated temperatures. Even countries with stronger cold chain systems may have to invest more to meet these more stringent conditions.
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