The world is eagerly watching the race to produce the COVID-19 vaccine with Oxford University-AstraZeneca, Moderna and Pfizer-BioNTech competing fiercely with their clinical trials.
Renu Swarup, Secretary of Department of Biotechnology (DBT) confirmed that 5 sites across the country are ready for the Oxford-AstraZeneca COVID-19 vaccine phase 3 human trials.
On the other hand, on July 27, the world’s biggest COVID-19 vaccine study by the US government got afoot with the first of 30,000 planned volunteers ready to receive shots.
India Is Ready For The Final Phase of the Human Vaccine Trial!
In a telephonic interview to PTI, Renu Swarup, the DBT secretary said, “This is an essential step because it is necessary to have data within the country before the vaccine is administered to Indians.”
Swarup stated that the DBT is part of any COVID-19 vaccine effort in India and added “… whether it is funding, whether it is facilitating the regulatory clearances or whether it is giving them access to different networks that exist within the country”.
She also said, “The DBT is now setting up Phase 3 clinical sites. We have already started working on them and five sites are now ready to be available for Phase 3 trials.”
“DBT is closely working with every manufacturer and Phase 3 trial of Serum (institute) is important because if the vaccine has to be successful and it has to be given to the Indian population we need to have the data within the country’, said the DBT secretary.
In conclusion she said, “For that, a Phase 3 trial has been proposed. Five sites are ready. Within some more weeks, they should be ready for manufacturers to take them up for clinical trial studies.”
More About the Vaccine from Oxford-AstraZeneca!
The Serum Institute of India (SII) is the largest vaccine manufacturer in the world.
The Pune-based firm has been chosen by Oxford and its partner AstraZeneca to manufacture the vaccine once it is ready.
Earlier, SII had said it will start manufacturing the vaccine even before the vaccine gets all permission so that sizable volumes are ready when all permissions are granted.
Trials’ results for the first two phases were published earlier this week in the medical journal The Lancet show Oxford COVID-19 vaccine ChAdOx1 nCoV-19 induces strong immune responses with no early safety concerns.
This upcoming phase 3 trial is the final phase of the vaccine trials.
SII has also sought permission from the Drugs Controller General of India (DCGI) for conducting phase 2 and 3 of human clinical trials of the potential vaccine.
The SII plans to manufacture 2-3 million doses of vaccine by the end of August.
The findings from study from earlier phases suggest that the vaccine triggered a T-cell (white blood cells that can attack cells infected with the SARS-CoV-2 virus causing COVID-19) response within 14 days of vaccination and an antibody response within 28 days.
Adar Poonawalla, CEO of SII, said, “It is too early to comment on the vaccine’s price. However, we will keep it under ?1,000 per dose.”
Furthermore he suggested that it is extremely likely that the COVID-19 vaccine would require two or more doses, like in the case of antidotes for measles and other diseases.
He added, “I don’t think any citizen of India or of any other country is going to have to pay for it because it is going to be bought by the government and distributed free.”
Poonawala claims that the vaccine is expected to reach the people of India in large numbers by the first quarter of 2021.
The US Vaccine Trials!
In March, the National Institutes of Health (NIH) developed a vaccine and was tested in people.
That first-stage study with around 45 participants showed that the vaccine increased the volunteers’ immune systems making it protective, with some minor side effects such as a brief fever, chills and pain at the injection site. Early testing of other leading candidates have had similarly encouraging results.
National Institutes of Health and Moderna Inc, a US based medical research centre, says that there’s still no guarantee that the experimental vaccine developed by them will really protect.
NIH’s Dr. Anthony Fauci recently told The Associated Press, “Unfortunately for the United States of America, we have plenty of infections right now.”
The scientists will closely track the volunteers. During the trial, volunteers will not know if they are getting the real shot or a placebo. After two doses, scientists observe which group experiences more infections as they go about their daily routines, especially in areas where the virus still is spreading unchecked.
The massive studies are to check the potential vaccine’s safety as well as to test if the shots work. After which the scientists will compare all the shots and their observations.
The U.S. requires its own tests of any vaccine that might be used in the country. It has set high expectations with the government-funded COVID-19 Prevention Network planning to roll out a new study of a leading candidate – each one with 30,000 newly recruited volunteers- every month through fall.
What Do Experts And Volunteers Have To Say?
Dr. Larry Corey, a virologist with the Fred Hutchinson Cancer Research Institute in Seattle, who helps oversee the study sites said that a massive number of people are needed to roll up their sleeves for science. But in recent weeks, more than 1,50,000 Americans filled out an online registry signaling interest.
Corey in a vaccine meeting last week by AP said, “These trials need to be multigenerational, they need to be multiethnic, they need to reflect the diversity of the United States population.” He pointed out that it’s especially important to ensure enough hard-hit Black and Hispanic population are participants in the trial.
Jennifer Haller of Seattle, one of the participants of the first-stage study told the AP, “We all feel so helpless right now. There’s very little that we can do to combat this virus. And being able to participate in this trial has given me a sense of, that I’m doing something.” She added, “Be prepared for a lot of questions from your friends and family about how it’s going, and a lot of thank-you’s.” The first recipient is encouraging others to volunteer now.
If the final phase becomes a success,, it still will take months for the first data to be revealed from the Moderna test, followed by the Oxford one.
If all goes as per plans – Oxford will commence its final phase from August followed by plans to test a candidate from Johnson & Johnson in September and Novavax in October. Pfizer Inc. also plans its own 30,000-person study this summer.
This article was first published in Trak.in
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