Updated: September 7, 2020 9:27:45 pm
According to the World Health Organization, about 175 vaccine candidates are in preclinical or clinical trials today.
While Russia and China may have stolen a march in the race to develop a Covid-19 vaccine, grant regulatory approval to vaccine candidates Even before phase III human trials, all eyes are on Pfizer’s other leading vaccine candidates, Oxford University-AstraZeneca and Moderna. All three are currently in the late testing phase and it has become clear that a vaccine would be available this year.
According to the World Health Organization, about 175 vaccine candidates are currently in pre-clinical or clinical trials. About 33 of them are in the clinical trial phase. Eight contenders are in the final stages, phase III of human trials. At least eight candidate vaccines are under development in India, of which two are in phase II testing phase.
Covid-19 Vaccine from University of Oxford-AstraZeneca
The ChAdOx1 nCoV-19 vaccine, considered a pioneer in the global race to provide an effective vaccine to combat Covid-19, is now in phase III clinical trials in Great Britain, Brazil, South Africa and India. The vaccine is made from a weakened version of a common cold virus, called adenovirus, that infects chimpanzees.
Latest updates:
💉 America has become the last country where Oxford University and AstraZeneca have started phase 3 clinical trials. Trials are likely to begin soon in Japan and Russia as well. In the US trials, about 30,000 participants are likely to enroll. Globally, the Oxford vaccine trials are expected to involve 50,000 participants.
💉 In India, the vaccine, known as Covishield, is undergoing combined phase 2 and phase 3 trials, which will cover 1,600 participants in India at 17 sites. The trials are run by the Serum Institute of India and will look at the safety and efficacy of the vaccine.
Australian Prime Minister Scott Morrison said the country would receive the first batches of the potential Covid-19 vaccine from Oxford in January. “Australia will receive 3.8 million doses of the vaccine in January and February 2021,” he said.
Pfizer-BioNTech Covid-19 Vaccine
The BNT162b2 vaccine being developed by Pfizer, in conjunction with German biotech company BioNTech, is also undergoing phase 3 trials. The vaccine uses messenger RNA for the immune system to recognize the coronavirus. Pfizer recently said that the first data from its phase 3 trials will be available in October.
Latest updates:
💉 According to a NYT report, Pfizer has said that it will request emergency use authorization for its vaccine starting in October from the US Food and Drug Administration, once it is established that the vaccine is truly effective . However, Pfizer CEO Albert Bourla has maintained that the firm will not take shortcuts. “If we don’t have the results of the Phase 3 study, we won’t submit them for approval or authorization,” he said.
💉 Preliminary results from phase I / II clinical trials published last month showed that the vaccine elicited a robust immune response in participants, which increased with the dose level and with a second dose.
💉 Pfizer has already manufactured hundreds of thousands of doses of the candidate vaccine, including at a plant in Belgium.
Modern Covid-19 Vaccine
The mRNA-1273 vaccine developed by the American biotech company Moderna is undergoing phase III trials in which scientists will evaluate a 100 µg dose of the candidate vaccine in about 30,000 participants in the US Moderna Inc plans to put a price of $ 50 to $ 60 per course for your coronavirus vaccine.
Latest updates:
💉 Last month, Moderna said that its vaccine elicited a promising immune response in elderly patients in early-stage clinical trials, indicating its potential efficacy in all age groups. The data showed that antibody levels in older adults were two to three times higher than those found in patients who had recovered from Covid-19.
💉 Currently, phase III trials are underway with 13,000 participants, of which 18% are Black, Latino, Native American or Alaska Native groups, Reuters reported. The company plans to complete registration for its last stage test in September.
💉 Last month, President Donald Trump announced that the US government would purchase 100 million doses of Moderna’s vaccine in a deal worth $ 1.53 billion. It has already received nearly $ 1 billion under the Operation Warp Speed program.
Gamaleya Institute, Russia Covid-19 Vaccine
The Sputnik V vaccine developed by the Gamaleya Institute in Moscow is the first in the world to be licensed for general use. It was approved by the Russian government on August 11, without phase 3 trials, drawing global criticism. The vaccine uses two adenoviruses to inject the genetic material of the new coronavirus into humans in order to trigger an immune response.
Latest updates:
💉 According to the results of phase 1 and phase 2 clinical trials published in The Lancet, the Russian vaccine has been found to be safe and has also triggered a “strong” immune response. Trials with 76 people show that the vaccine induced antibody responses in all participants within 21 days.
💉 Phase 3 trials will begin soon in many countries, including Saudi Arabia, the United Arab Emirates, Brazil, and the Philippines, and the developers plan to enroll 40,000 volunteers.
💉 With India showing interest in the Sputnik V vaccine, the Gamaleya Institute has submitted “comprehensive data” on the safety and efficacy of the vaccine to authorities. Separate phase 3 clinical trials can also be conducted in India after necessary approvals from regulators.
💉 By next week, the vaccine will be released for civilian use, Russia’s TASS agency reported. “In a few days, between September 10 and 13, we will obtain permission to release a batch of the vaccine for civilian use,” said Denis Logunov, deputy director of research and associate member of the Russian Academy of Sciences.
Covaxin from Bharat Biotech
India’s first indigenous Covid-19 vaccine, Covaxin from Bharat Biotech, will begin phase II human trials. Covaxin, an “inactivated” vaccine, works by injecting doses of the virus that have been destroyed so that the body produces antibodies against it without the virus posing a threat.
Latest updates:
💉 Bharat Biotech will conduct phase II trials with 380 participants. In the first phase of the Covaxin trial, about 375 participants were studied at 12 sites.
💉 Dr. Savita Verma of the Postgraduate Institute of Medical Sciences (PGI), Rohtak, has said that no adverse events were reported in subjects treated with Covaxin.
The different phases of the vaccine test:
Preclinical tests: At this stage, scientists test the vaccine in the laboratory using cells or animals.
Phase I trials: This is the first step in which the experimental vaccine is administered to humans and the safety, dosage, and possible side effects are examined. This stage generally takes about two months and involves a small number of participants, usually 20 to 100 healthy volunteers.
Phase II trials: At this stage, several hundred people sign up for the test and are divided into age groups, such as children and the elderly. This stage studies the immunogenicity of the candidate vaccine, the proposed doses, the immunization schedule and the method of administration.
Phase III trials: At this stage, the candidate vaccine is tested in hundreds or thousands of volunteers to determine its ability to prevent infections in humans in real-life situations (outside of laboratory conditions). During a pandemic, a vaccine can receive emergency use authorization before a formal green sign.
Approval: After Phase III testing, the developer submits a license request to the regulatory authority of their respective country. The regulator then inspects the factory where the vaccine will be made and approves its labeling.
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