If the late stage trials succeed in showing that the candidate is effective in preventing a person from getting Covid-19, Pfizer and BioNTech will be "on track" to approaching the American drug regulator for approvals as early as October this year.
Currently, Moderna has 87 testing sites across the US for phase 3 trials test the vaccine's safety and efficacy on a large number of people in different locations. Phase 3 will determine if it provides protection. Moderna has received almost $1 billion from the us government, which has chosen it as one of the first to enter large-scale human trials.
The company is working with South Korea's MedyTox, according to the World Health Organization's list of candidate vaccines.
A phase three study of a potential COVID-19 vaccine has officially begun in the United States.
Moderna's phase 2 testing is still ongoing, but its phase 1 results showed the vaccine was overall safe and triggered immune responses among volunteers.
Cadila's other vaccine is of a different type than the one which has gone into human trials.
Four weeks after the monkeys received their second injection, they were exposed to the SARS-CoV-2 virus, both through the nose and directly to the lungs via a tube.
Trial volunteers will receive two injections about 28 days apart, with volunteers randomly assigned to receive either two 100 microgram injections of mRNA-1273 or two shots of a saline placebo. Moreover, this trial will be a blind one, where both the volunteers and the researchers will not know which one is given to whom.
The study was funded by "Intramural Research Program of the Vaccine Research Center (VRC), NIAID, NIH, and the Office of the Assistant Secretary for Preparedness and Response, BARDA, Department of Health and Human Services (contract 75A50120C00034)".
To the question of balancing the safety and efficacy of the vaccine with the need to put it on the block as quickly as possible, Dr Swarup said that safety of the vaccine would never be compromised as all data is vigorously reviewed by the regulators before giving the go-ahead.
The company was able to move fast because it uses a novel technology based on messenger ribonucleic acid, which transcribes the genetic code of a virus inside a human cell, to teach the immune system to recognise it. It is the first of 160 vaccines in development to reach phase 3 clinical trials. The findings do not guarantee that the vaccine will perform the same way in people, but the results are considered encouraging and a milestone in the struggle against the pandemic.
"If you look at measles and polio, where there was a desperate urgency, it still took 4-5 years to develop an effective vaccine".
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