Moderna seeks US, EU emergency approval for COVID-19 vaccine

Israel expected to receive at least 2 million doses next year.

Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Moderna logo in this illustration taken October 31, 2020.  (photo credit: REUTERS)
Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Moderna logo in this illustration taken October 31, 2020.
(photo credit: REUTERS)
Moderna Inc. said it will apply for US and European emergency authorization of its COVID-19 vaccine on Monday based on full results from a late-stage study showing its vaccine was 94.1% effective with no serious safety concerns.
The company also reported a 100% success rate in preventing severe cases.
Israel has a contract with Moderna to receive at least two million doses – enough to vaccinate one million people – worth NIS 240 million. The first doses are expected to arrive in the country sometime at the beginning of next year.
Moderna’s Israeli-born chief medical officer Tal Zaks told The Jerusalem Post that Israel will be among the first in line.
Once the company’s vaccine is approved abroad, it would still need to be approved by Israel’s Health Ministry and registered for use in the country. However, that process is expected to be straightforward and move relatively quickly, so long as Moderna receives approval in the US.
Israel was one of the first countries to sign on to receive the company’s novel coronavirus vaccine back in June. Zaks became a regular personality on the 8 p.m. news and was named among the Post’s “50 Most Influential Jews of 2020.”
“We want to get these vaccines quickly if they are developed and when they will be developed – it puts us in a very good place in the world,” Prime Minister Benjamin Netanyahu said at the time.
The filing sets Moderna’s product up to be the second vaccine likely to receive US emergency use authorization this year.
“We believe that we have a vaccine that is highly efficacious. We now have the data to prove it,” Zaks said in a telephone interview. “We expect to be playing a major part in turning around this pandemic.”
Zaks said he was emotional after seeing the 94.1% result over the weekend: “It was the first time I allowed myself to cry. At this level of effectiveness, when you just do the math of what it means for the pandemic that’s raging around us, it’s just overwhelming.”
Moderna’s announcement follows news from Pfizer Inc. and German partner BioNTech SE that their vaccine, which also uses a new technology called synthetic messenger RNA (mRNA), was 95% effective. Pfizer has already applied for emergency use authorization, putting it about a week ahead of Moderna.
Israel is also slated to receive eight million doses of the Pfizer vaccine – enough to inoculate four million Israelis.
Pfizer said it would start delivering vaccines to Israel as early as December, although the majority of doses are only expected to arrive in the country by mid-2021.
In addition to filing its US application, Moderna said it would apply for conditional approval from the European Medicines Agency, which has already begun a rolling review of data, and would continue to talk with other regulators conducting rolling reviews.
Moderna’s latest efficacy result is slightly lower than an interim analysis released on November 16 showing 94.5% effectiveness, a difference that Zaks said is not statistically significant.
Both the Moderna and Pfizer vaccines proved more effective than anticipated and far superior to the 50% benchmark set by the US Food and Drug Administration (FDA).
Britain’s AstraZeneca has announced an average efficacy rate of 70% for its vaccine and as much as 90% for a subgroup of trial participants who got a half dose first, followed by a full dose. But some scientists have expressed doubts about the robustness of the 90% efficacy figure for the smaller group.
Still, the past few weeks of positive vaccine results have ignited hopes for an end to a pandemic that has battered economies and claimed almost one and a half million lives worldwide.
It comes at a time when Israel is seeing a resurgence of infection – with around 1,000 new cases per day.
Independent advisers to the FDA are scheduled to meet on December 17 to review Moderna’s trial data and make a recommendation to the agency. They will meet a week earlier on December 10 to review Pfizer’s data.
Shortly after gaining emergency use authorization, Moderna expects the vaccine to be shipped to designated distribution points throughout the United States by the government’s Operation Warp Speed program and McKesson Corp, a drug distributor contracted by the US government.
Its distribution is expected to be easier than Pfizer’s because while it does need to be stored in a freezer, it does not require the ultra-cold temperature needed by Pfizer’s vaccine.
Of the 196 volunteers who contracted COVID-19 among the more than 30,000 people in the Phase 3 trial, some 185 had received a placebo versus 11 who got the vaccine. The company reported 30 severe cases – all in the placebo group – which means the vaccine was 100% effective at preventing severe cases. The trial included one COVID-19-related death in the placebo group.
Moderna said the vaccine’s efficacy was consistent across age, race, ethnicity and gender demographics. The 196 cases included 33 adults over 65 and 42 volunteers from racially diverse groups, including 29 Latinos, six Blacks, four Asian Americans and three multiracial participants.
Zaks said the vaccine has been developed during a period of “political acrimony,” and that having a highly effective vaccine may go a long way toward erasing some of that distrust.
“This is as black and white as an effect on a population will be. Your chances of actually being sick if you’ve been vaccinated are decreased 20-fold,” he said.
Moderna reported no new side effects since its interim analysis on November 16. Based on that analysis, the most common side effects were fatigue, injection-site redness and pain, headache and body aches, which increased after the second dose and were short-lived.
Zaks said the vaccine caused significant flu-like symptoms in some participants, which, he said, “goes hand-in-hand with having such a potent vaccine.” But it has not caused any significant safety concerns so far.
“There is a race to get the public vaccinated, so we are willing to take more risks,” Tal Brosh, head of the Infectious Disease Unit at Samson Assuta Ashdod Hospital, told the Post in a previous interview. He acknowledged that there are unique and unknown risks to mRNA vaccines, including local and systemic inflammatory responses that could lead to autoimmune conditions.
But others told the Post that there is no cause for concern.
“There can always be long-term effects – not just of these new mRNA vaccines, but in general,” said Cyrille Cohen, head of the immunotherapy laboratory at Bar-Ilan University. “But remember, we don’t know yet that there won’t be long-term effects of COVID-19.”
Moderna plans to start a new trial to test the vaccine in adolescents before the end of the year, followed by another trial in even younger volunteers early in 2021. The company hopes to have the vaccine available for adolescents by September of next year, Zaks said.
Other vaccine makers have said they are studying their vaccines in young people as well.
Moderna said it was on track to have about 20 million doses of its vaccine ready to ship in the United States by the end of 2020, enough to inoculate 10 million people.


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