WASHINGTON, 17 Nov 2020:
A biotech firm in th eUS yesterday announced a coronavirus candidate vaccine it is developing has a 94.5% efficacy rate.
In a statement, Moderna said the clinical “trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.”
The news follows a similar announcement made earlier this month by US pharmaceutical giant Pfizer and German firm BioNTech, who said their vaccine had 90% efficacy in fighting off the virus.
Public health officials around the world have pegged most of their hopes of fully overcoming the virus on a vaccine.
Moderna said it will present the documentation in the next few days for its definitive approval from the Food and Drug Administration (FDA).
The trial, known as the COVE study, recruited more than 30,000 participants in the US and was conducted, in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.
Moderna has developed an “RNA vaccine,” which means that part of the genetic code of the coronavirus is injected into the body, enabling the production of sufficient antibodies in the host’s immune system.
As explained in Moderna’s statement, the study’s main assessment criterion is based on the analysis of confirmed Covid-19 cases and adjudicated from two weeks after the second vaccine dose.
“This first interim analysis was based on 95 cases, of which 90 cases of Covid-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5%.”
The statement added that the study had reported 11 severe cases of Covid-19, all of which occurred in the group who had been administered a placebo.
The 95 cases of Covid-19 included 15 older adults (65+) and 20 participants who identified themselves as belonging to diverse communities (including 12 Hispanic or Latino, 4 black or African-American, 3 Asian-American and 1 multiracial), the company says.
Moderna says a review of the side effects concluded “the vaccine was generally well tolerated” and that most of the “adverse events were mild or moderate in severity” as well as being short in duration.
“Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.”
In Moderna’s statement, executive director Stéphane Bancil said: “This is a pivotal moment in the development of our Covid-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible.
“All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent Covid-19 disease, including severe disease.”
Meanwhile, World Health Organisation (WHO) director general Tedros Adhanom Ghebreyesus said “this is not the time for complacency” despite encouraging recent results from trials of coronavirus candidate vaccines – given the sharp increase in cases in regions such as Europe or America.
While Tedro said news the efficacy rate of more than 90% of these potential vaccines as announced by Moderna and by Pfizer-BioNTech was “encouraging” and health authorities “remain cautiously optimistic about the potential for new tools” to fight coronavirus, WHO is “extremely concerned by the surging cases we are seeing, particularly in Europe and the Americas.”
“Health workers and health systems are being pushed to the breaking point.” The WHO director-general also warned that a worrying number of Covid-19 patients are being detected with long-term health consequences after overcoming the disease.
He said every country must use all of the resources at their disposal to continue fighting the spread of the coronavirus, from tracking cases to quarantining those who are suspected of being affected, and warned that not doing so “can lead to death, suffering and effects to their economies.”
WHO chief scientist Soumya Swaminathan welcomed the aforementioned 94.5% efficacy of the vaccine developed by Moderna, although she pointed out that “more data must be taken into account and possible effects on patients must be expected for at least two months.”
Moderna, unlike Pfizer-BioNTech, is on the list of laboratories whose funding for the development of anti-Covid vaccines is supported financially by the WHO and the international community through the CoVax programme and in exchange for facilities in their distribution in poor countries.
Swaminathan clarified that before deciding which anti-Covid vaccines, and from which laboratories, would be distributed globally as part of the programme, different criteria will be taken into account – not only the effectiveness but also the cost, storage facilities, and the number of doses needed, among others.