Moderna to Ask FDA for Emergency Authorisation of Covid-19 Vaccine on Monday

Moderna to Ask FDA for Emergency Authorisation of Covid-19 Vaccine on Monday
Nurse Jessica Franz walks past a mobile morgue at Olathe Medical Centre on Nov. 26, 2020, in Olathe, Kansas. (Photo: Charlie Riedel, AP)

Biotech company Moderna will ask for an emergency use authorisation from the U.S. Food and Drug Administration for its covid-19 vaccine on Monday, according to a new press release posted to the firm’s website. Moderna also released new information indicating its messenger RNA-based vaccine has a 94.1% efficacy rate in a study of 30,000 people — encouraging news for Americans still struggling with an uncontrolled pandemic. Moderna said it will also seek approval with the European Medicines Agency.

“This positive primary analysis confirms the ability of our vaccine to prevent Covid-19 disease with 94.1% efficacy and importantly, the ability to prevent severe Covid-19 disease,” Moderna CEO Stéphane Bancel said in a statement. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalisations and death.”

Just 196 people in the latest Moderna trial contracted the coronavirus, with 185 of those cases occurring in the group who received a placebo rather than the actual experimental vaccine. None of the 11 people who received the vaccine but still contracted the virus showed signs of severe illness, whereas there were 30 cases of severe illness in the placebo group, including one person who died.

Moderna’s vaccine requires two doses spaced about one month apart. Reported side effects included “injection site pain, fatigue, myalgia [muscle pain], arthralgia [joint pain], headache, and erythema/redness at the injection site,” according to the company.

There are two other high-profile vaccines being produced in the U.S. and Europe, including another mRNA vaccine from U.S.-based Pfizer developed with the German firm BioNTech. Pfizer, whose vaccine is reportedly 95% effective based on early data, is scheduled to give a presentation to the FDA on December 10, according to the Associated Press. Moderna will likely give its presentation the following week.

AstraZeneca has also developed a vaccine in the UK with Oxford University that’s not based on the newer mRNA technology used in the Pfizer and Moderna vaccines, and while AstraZeneca’s shot remains encouraging for its relative low cost and ease-of-storage, new concerns have been raised over transparency and the company’s clinical trials. It was only revealed late last week that some of the findings in AstraZeneca’s latest trial had been the result of errors in dosing rather than intentional scientific effort. Many experts were stunned when AstraZeneca found its vaccine worked better when study participants only received a half dose and then a full dose. This anomaly was encouraging but hard to explain, and it raised even more questions when it was later revealed on an investor phone call that the half dose had been given by mistake.

The U.S. recorded over 131,000 new cases of covid-19 and 790 new deaths on Sunday, numbers that are probably artificially low because of delays in data reporting due to the holiday weekend, according to the Covid Tracking Project. The number of Americans currently hospitalised with covid-19 reached a record high of 93,238 yesterday.

If FDA quickly gives authorisation to Moderna’s vaccine, there are still a lot of questions about who will get the vaccines first. Top priority will be medical professionals like doctors and nurses who are treating covid-19 patients, but the White House hasn’t publicly articulated a plan for which group will be second, an important question for everyday Americans.

Former FDA commissioner Scott Gottlieb, a regular on TV news shows, brought up this point of who may get the shot after health care workers on Sunday and said that it’s not clear whether priority will be given to the elderly or to so-called essential workers. If the goal is to limit the spread of the virus, it should go to essential workers, Gottlieb told CBS News host Margaret Brennan on “Face the Nation.” But if the goal is to save lives immediately, elderly Americans should be the first to receive the vaccine.

“There’s only going to be 40 million doses available throughout the whole month of December if both companies get authorised on time,” Gottlieb said about the Moderna and Pfizer vaccines, noting that there won’t be enough vaccine for many people beyond health workers in that first batch.

“There’s about 85 million essential workers who might be eligible to be vaccinated if you — if you bifurcate it to that group. And there’s about 50 million people over the age of 65, 20 million over the age of 75,” Gottlieb continued. “And so that’s going to be some debate about which group gets prioritised first.”

It’s tough to decide who should get priority during a pandemic, but health care workers are already in the unenviable decision of doing precisely that as the number of cases and deaths continue to rise with each passing day. While hotspots of infection are slowing down, however modestly, in places like the Midwest, other parts of the country are seeing a disturbing rise in new cases and hospitalisations, including the West and the Northeast.

In California, for example, the number of people hospitalised with covid-19 has doubled since November 12, going from roughly 4,000 to 8,000 patients, according to the Covid Tracking Project. The vaccine simply can’t get here fast enough.