American firm Moderna said it would apply to US and European regulators to grant emergency use of its COVID-19 vaccine, after further evidence confirmed the efficacy of its jab, strengthening hopes a solution to the coronavirus pandemic might be in sight.
The filing on Monday sets Moderna’s product up to be the second vaccine likely to receive US emergency use authorisation this year following a shot developed by Pfizer and BioNTech, which had a 95 percent efficacy rate.
“We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it,” Moderna’s Chief Medical Officer Tal Zaks said. “We expect to be playing a major part in turning around this pandemic.”
The news came as US hospitals have been stretched to the limit with more than 160,000 new cases per day and more than 1,400 daily deaths. Since first emerging nearly a year ago in China, the virus has killed more than 1.4 million people worldwide.
Moderna created its vaccine with the US National Institutes of Health. Findings showed on November 16 the jabs were 94.5 percent effective. The company, however, said it got the final needed results over the weekend, which indicated the vaccine was 94.1 percent effective.
Moderna also reported its vaccine’s efficacy rate was consistent across age, race, ethnicity and gender demographics as well as having a 100 percent success rate in preventing severe cases of a disease
Zaks said when he learned the results, “I allowed myself to cry for the first time”.
“We have already, just in the trial, saved lives. Just imagine the impact then multiplied to the people who can get this vaccine,” said Zaks.
Moderna is just behind Pfizer and its German partner BioNTech – which applied for emergency approval on November 20 – in seeking to begin vaccinations in the US in December.
Moderna shares were up 6.7 percent in US pre-market trade, a record high and a rise of more than 600 percent this year.
What happens next?
Moderna said the shots’ effectiveness and a good safety record so far – with only temporary, flu-like side effects – mean they meet requirements set by the US Food and Drug Administration (FDA) for emergency use before the final-stage testing is complete.
Zaks said the flu-like symptoms in some participants “goes hand-in-hand with having such a potent vaccine”, but it has not caused any significant safety concerns so far.
“As the numbers of cases reported grows, confidence grows that this amazing protection will be maintained in a product that can be rolled out to protect the public,” said Alexander Edwards, associate professor in biomedical technology at Britain’s University of Reading.
In addition to filing its US application, Moderna said it would seek conditional approval from the European Medicines Agency, which is already reviewing its data, and would continue to talk with other regulators doing similar rolling reviews.
The European Medicines Agency, Europe’s version of FDA, has signaled it also is open to faster, emergency clearance.
FDA scientific advisers will now hold a public debate to assess whether there is enough evidence behind each candidate. On December 10, Pfizer-BioNTech will present its data, while Moderna’s findings are expected to be discussed a week later, on December 17.
“Pending the outcomes of these hearings … The vaccines could be quickly rushed into production and in the market as early as this year,” said Al Jazeera’s Kimberly Halkett, reporting from Washington DC.
“This is something [President] Trump has repeatedly said would happen and something he has been trying to take credit for given the fact that much of these have been developed using funds from what he calls ‘Operation Warp Speed,” she added.
Moderna said if it can get regulators’ approval, certain categories of people could get the jabs as early as December 21.
In mid September, the biotechnology company said it was producing 20 million doses by the end of the year, while its final goal was to make up to one billion doses for 2021.
Pfizer said it can produce as many as 50 million doses in 2020. Both vaccines require a double shot per person.
On Tuesday, experts from the Centers for Disease Control and Prevention will meet to discuss the vaccines’ allocation of initial supplies.
The highest risk groups such as the elderly, medical professionals, and healthcare workers are expected to be prioritised.
Both the Moderna and Pfizer vaccines proved more effective than anticipated and were far superior to the 50 percent benchmark set by the FDA.
The past few weeks of positive vaccine results have ignited hopes for an end to a pandemic that has battered economies and come as new infections and COVID-19 hospitalizations are at record levels across the US.
Azra Ghani, chair in infectious disease epidemiology at Imperial College London, said Monday’s details confirmed the vaccine was highly effective.
“Whilst this does not exclude some risk of severe disease after vaccination given the relatively small number of severe cases, these results suggest very high efficacy,” she said.