Moderna and Pfizer have released their study protocol, making public details on how their COVID-19 vaccine will be evaluated.
The two drug companies have abandoned their traditional secrecy and released comprehensive road maps of coronavirus vaccine evaluation due to “public pressure”, said a report by The New York Times.
According to the report, both the companies have revealed details including the process of selecting participants for trials of vaccine and monitoring them.
The conditions under which the trials could be stopped early if there were problems and the evidence researchers will use to determine whether people who got the vaccines were protected from COVID-19 have also been revealed, said the report.
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 sharing of these details while the trials are still underway is a “rare move” as companies typically do this after their studies are complete, as per the report.
However, in case of the COVID-19 vaccine, it has been done to address the growing suspicion among Americans that President Donald Trump’s drive to produce a vaccine before the November 3 election could result in a product that was unsafe.
Trump, who is seeking a re-election, has said a vaccine to fight the coronavirus pandemic is possible before the polls, raising concerns over political interference. Following his remarks, scientists have questioned whether drugmakers will have enough evidence to achieve success by that time.
Moderna and Pfizer are on the human clinical trial stage of their respective COVID-19 vaccine candidates.
Moderna's vaccine candidate - mRNA-1273 - is nearing the finish line in its push to enroll 30,000 individuals in a late-stage trial of a novel coronavirus vaccine.
For Pfizer’s vaccine, developed together with Germany's BioNTech SE, more than 29,000 people have enrolled in the trial that started in July, some receiving the vaccine and the others receiving a placebo.Follow our full coverage on COVID-19 here.