After experts, including US officials, pointed out "several glaring absences" in the data released by AstraZeneca, the company's Chief Executive Officer Pascal Soriot has said that it might conduct another global trial of the Oxford COVID-19 vaccine, according to a Bloomberg report.
Instead of adding the trial arm to an ongoing U.S. process, the CEO said a new study would be run to evaluate a lower dosage that performed better than a full amount in AstraZeneca's studies, according to the report.
"Now that we’ve found what looks like a better efficacy we have to validate this, so we need to do an additional study," Soriot was quoted as saying by Bloomberg, adding that the new study could be "international study, but this one could be faster because we know the efficacy is high so we need a smaller number of patients".
AstraZeneca and the University of Oxford announced this week that their inexpensive, easy-to-produce coronavirus vaccine appeared effective, with the average efficacy of about 70 percent.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
The Serum Institute of India, the world's largest vaccine maker by volume, has partnered with AstraZeneca, the Gates Foundation and the Gavi Alliance to produce more than a billion doses of the vaccine for global supply.
Follow Moneycontrol's COVID-19 Vaccine Tracker here.
Among the experts who have raised questions about the gap in information released on November 23 include those from the US Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC), according to CNN.
AstraZeneca has acknowledged a key mistake in the vaccine dosage received by some study participants, the New York Times said in a report. This admission has added to questions about whether the "vaccine's apparently spectacular efficacy will hold up under additional testing."
Along with the error, scientists and industry experts said a series of other irregularities and omissions in the manner in which AstraZeneca initially disclosed the data have also eroded confidence in the reliability of their results.As it came to light that the vaccine's most promising results did not reflect data from older people, it appears difficult that regulators in the US and elsewhere will quickly authorise emergency use of the AstraZeneca vaccine.