There’s more good news on the COVID-19 vaccine front today: biotechnology company Moderna reported in a press release this morning that its mRNA vaccine was found to be 94.5 percent effective at preventing COVID-19 in an interim analysis of a large Phase III study . The news comes just a week after similar results came out via a press release for another mRNA vaccine developed by pharmaceutical giant Pfizer and German biotech company BioNTech.
But while health experts are “cautiously optimistic” for these and many other vaccines in the coming months, they warn that such a timeline won’t be fast enough to spare lives and health care systems from the current spike in disease.
“Right now, we are very concerned about the increase in the number of cases we are seeing in some countries,” Tedros Adhanom Ghebreyesus, director-general of the World Health Organization, said at a news conference Monday. “Especially in Europe and America, health workers and health systems are pushed to their limits.”
dr. Tedros and other WHO officials stressed that – while having an effective vaccine is critical to defeating the novel coronavirus – SARS-CoV-2 – it is not the end of the battle. Vaccine implementation will be the next difficult challenge, one that will require significant infrastructure and resources from healthcare systems – some of which are currently overwhelmed in many places.
Getting an effective vaccine is “like building a base camp on” [Mount] Everest,” Kate O’Brien, director of the WHO’s immunization, vaccine and biologics division, said Monday. “But the climb to the top is really about delivering the vaccines. And that cannot be emphasized enough.”
Still, the news of Moderna’s trial raised eyebrows and optimism. “The data is striking…it’s really quite impressive,” top infectious disease expert Anthony Fauci said in a: Today interview early Monday. “Help is on the way – it certainly is,” he added. “But the fact that aid is on the way should give us even more incentive to double down on some of the public health measures, to be able to use the combination of a vaccine and public health measures to turn this around. We can do it.”
Moderna’s results come from an interim analysis of its Phase III trial, which started when the study registered 95 cases of symptomatic COVID-19 among its 30,000 participants. An independent control board reported that 90 of those cases occurred in participants who received a placebo, while the remaining five cases occurred in the group that received Moderna’s vaccine, mRNA-1273. That gives an estimate of 94.5 percent efficacy, although that percentage may very well change once the study reaches 151 cases and a median follow-up time of two months for all participants.
Of the 95 cases, 11 were considered serious. All 11 cases were in the placebo group.
Moderna also noted in its press release that in the 95 cases, 15 were people over the age of 65 and 20 identified from racial and ethnic minorities.
Adverse reactions were mostly mild to moderate, but some patients reported “Grade 3” events. According to the Food and Drug Administration, such events are significant and prevent daily activities, but do not require hospitalization. The Grade 3 events included “injection site pain (2.7 percent) and, after the second dose, fatigue (9.7 percent), myalgia (8.9 percent), arthralgia [joint pain] (5.2 percent), headache (4.5 percent), pain (4.1 percent), and injection site erythema/redness (2.0 percent). Moderna noted that these effects were “generally short-lived.”
The press release was praised by experts for the amount of information it provided. “It’s a pretty detailed press release,” said WHO chief scientist Dr. Soumya Swaminathan Monday. By contrast, Pfizer and BioNTech’s press release last week did not include information about the severity of the disease or the age and diversity of the participants.
Moderna also offered an advantage over Pfizer and BioNTech in a separate press release, touting the vaccine’s storage conditions. Unlike the Pfizer/BioNTech mRNA vaccine, which must be stored at -70°C, new data suggest that Moderna’s vaccine remains stable at 2° to 8°C (36° to 46°F) – the temperature of a standard home or medical refrigerator — for 30 days.
“We are pleased to submit these expanded stability conditions for mRNA-1273 to regulators for approval,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna, in the press release. “The ability to store our vaccine at -20°C for up to 6 months, including up to 30 days under normal refrigeration conditions after thawing, is an important development and would allow for easier distribution and greater flexibility to allow vaccination on a larger scale in the United States. to ease. and other parts of the world.”
Such conditions will make shipping and deploying vaccines significantly easier in a variety of settings, WHO experts acknowledge.
With the good news Monday, lame US President Donald Trump was quick to take credit for the vaccine’s success to date. In a tweetTrump said in part, “For those wonderful ‘historians’, please remember that these amazing discoveries … all happened on my watch!”
Moderna’s vaccine was developed in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and received nearly $1 billion in funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the United States Department of Health and Human Services.
This is in contrast to the Pfizer/BioNTech vaccine, which was not developed with federal funding.
In addition, Moderna also agreed to a deal worth up to $1.525 billion to provide the United States with 100 million doses of vaccine through Operation Warp Speed.
Moderna said it will apply for an Emergency Use Authorization (EUA) from the Food and Drug Administration “in the coming weeks.” The company plans to have approximately 20 million doses of mRNA-1273 ready for shipment in the U.S. by 2020 and another 500 million to 1 billion doses worldwide by 2021.
But while all of this happened on Trump’s “watch,” the country is also in a nightmarish wave of coronavirus and disease cases. The current seven-day average in daily cases has risen to over 145,000, with a dizzying peak of over 170,000 last Friday. Hospital admissions are also at an all-time high, with nearly 70,000 people currently hospitalized with COVID-19. Deaths, which are typically weeks behind cases and hospitalization, are also starting to rise.
“There is no excuse for passivity,” said Dr. Tedros Monday in response to the spikes. “My message is very clear: act quickly, act now, act decisively. A laissez faire attitude to the virus – not using the full range of available tools – leads to death, suffering and damages livelihoods and economies.”