Introduction
Respite from the COVID situation may be coming sooner than we anticipated, with countries such as Britain already following through with mass vaccination.
Globally more than 10 Billion doses have been pre ordered, with the USA government alone spending more than $9 billion to develop and manufacture candidate vaccines. Pharmaceutical giants, Biotech Companies and Research organizations have joined forces and geared their attention to combat 2020’s biggest roadblock, the COVID-19 Pandemic.
Organizations are running a race against time to effectively launch vaccines for mass immunization.
Typical Trial Phase for Vaccine Development
1. Pre-clinical: Animal trial
2. Phase 1: Safety trial
3. Phase 2: Large group trial
4. Phase 3: Efficacy trial
5. Regulatory approval
This testing usually lasts a period of 10-15 years
Operation Warp Speed and Top Contenders
Through a White House initiative dubbed Operation Warp Speed, the United States is aiming to deliver 300 million doses of a COVID-19 vaccine by January 2021, bringing down the trial period to a 1-year duration.
As of November, WHO registered 59 candidates who are working towards development of the boosters. Here are some of the top contenders-
1. mRNA-1273
Company: Moderna Biotech
Country: United States of America
Type of vaccine: mRNA
Status report: The company began a phase 3 trial on 27 July, and has enrolled roughly 30,000 people. Moderna intends to submit for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in the coming weeks. Moderna’s vaccine remains stable in conventional refrigerators for a month and ordinary freezers for six months, providing it an edge over others as it can be distributed even in parts of the world that do not have the infrastructure to maintain extremely low temperatures.
Testing/efficacy: An analysis conducted on 15 November by an independent data-safety committee found that 95 participants in the trial had developed COVID-19. Of these, 90 were in the group that received a placebo injection and 5 had received the vaccine, which equates to an efficacy of 94.5%. The interim data suggest that the efficacy could be as low as about 86%, because of statistical uncertainty. Moderna expects to have 20 million doses available in USA, with to one billion doses available for use around the world next year and is planning to seek approval in other countries too.
The UK has announced that, from spring, it will have five million doses of the Moderna vaccine, enough to vaccinate 2.5 million people.
2. BNT162b2
Company: Pfizer Inc. and BioNTech SE
Country: United States of America, approved in Britain, Canada, Bahrain, Saudi Arabia and Mexico
Type of vaccine: mRNA
Status report: An expert committee convened by the US Food and Drug Administration voted heavily in favour of recommending the Pfizer-BioNTech Covid-19 vaccine for emergency use approval on 10th December 2020. The final voting tally was 17 in favour, four against and one abstention.
The vaccine is the first in the world to complete a large-scale, phase 3 clinical trial.
The full results of the trial, which included nearly 44,000 people, were published in the New England Journal of Medicine. However, the vaccine requires temperatures of -70°C for proper storage, which is attainable only with an advanced cold storage system. Underdeveloped countries will be unable to cater to these needs.
Testing/efficacy: the vaccine was 95 percent effective with no serious safety issues. Britain on 9th December reported that two health care workers developed significant allergic reactions to the vaccine as the country rolled out its massive drive Tuesday.
The FDA will therefore include a warning label on the vaccine. Initial shipment of about 2.9 million doses of the vaccine will be sent around the United States over the next week.
3. ChAdOx1 nCoV-19 (AZD1222)
Company: Oxford University, AstraZeneca
Country: United Kingdom, non- profit vaccine targeting Lower-middle income countries
Type of vaccine: chimpanzee adenovirus vaccine vector
Status report: Currently in the end of phase 3. After phase 1 results supported a two-dose regimen, the trial protocols were amended where necessary to require two standard doses. The paper, assessed by independent scientists, sets out full results from advanced trials of over 20,000 people. The lower dose was the result of a manufacturing mistake and only tested in a younger group. Astra planned to set up an additional, probably global, trial, while Oxford had no plans for an extra U.K. trial. The Vaccine is a part of Covax, the global initiative that is hoping to distribute about 2bn doses to 92 low- and middle-income countries at a maximum cost of $3 a dose. Moreover, the Serum Institute of India (SSI) will produce 1bn doses under license from AstraZeneca for India and low-income countries with the aim of producing 400m doses by the end of the year. Testing/efficacy: The interim trial results reported three efficacy levels for the vaccine - an overall effectiveness of 70%, a lower one of 62% and a high of 90%. 1,367 people - out of many thousands in the trial - received the half dose followed by a full dose, which gave them 90% protection against getting ill with Covid-19. None of that group were over the age of 55 though. While the vaccine’s efficacy rate may be enough to get it approved, the variability in different subgroups and lack of data for older people should give regulators pause in rushing this through.
Some other developers include (Sinovac Biotech Ltd., china), Cansino Biologics (china), Gamaleya Research Centre (Russia), Sinopharm (china), Johnson and johnson (USA), Novavax (USA).
Every grey cloud has a silver lining and with these giant biotech advancements coming in at unbelievable speeds, our lives may get back to normal sooner than anticipated.
However, warping the trial period to hasten the process does undermine the safety and efficacy of these vaccines. Are we willing to risk a chance of secondary infection in the hopes of eradicating COVID-19?
~Devangi Sharma
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