Moderna seeks US, EU approval for vaccine as final results show 94% efficacy

Moderna Inc. said it would ask US and European regulators Monday to allow emergency use of its COVID-19 vaccine as new study results confirm that the shots offer strong protection — ramping up the race to begin limited vaccinations as the coronavirus rampage worsens.

Multiple vaccine candidates must succeed for the world to stamp out the pandemic, which has been on the upswing in the US and Europe. US hospitals have been stretched to the limit as the nation has seen 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 is just behind Pfizer and its German partner BioNTech in seeking to begin vaccinations in the US in December. Across the Atlantic, British regulators also are assessing the Pfizer shot and another from AstraZeneca.

Moderna created its shots with the US National Institutes of Health and already had a hint they were working, but said it got the final needed results over the weekend that suggest the vaccine is more than 94 percent effective.

In this March 16, 2020, photo, a pharmacist gives Jennifer Haller, left, the first shot in the first-stage safety study clinical trial of a potential Moderna Inc. vaccine for COVID-19 at the Kaiser Permanente Washington Health Research Institute in Seattle. (AP Photo/Ted S. Warren, File)

Of 196 COVID-19 cases so far in its huge US study, 185 were trial participants who received the placebo and 11 who got the real vaccine. The only people who got severely ill — 30 participants, including one who died — had received dummy shots, said Dr. Tal Zaks, the company’s Israeli chief medical officer.

When he learned the results, “I allowed myself to cry for the first time,” Zaks told The Associated Press. “We have already, just in the trial, have already saved lives. Just imagine the impact then multiplied to the people who can get this vaccine.”

In this Jan. 27, 2020, still image from video, Moderna Chief Medical Officer Tal Zaks speaks during an interview at the company headquarters in Cambridge, Massachusetts (AP Photo/Rodrique Ngowi)

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 for emergency use before final-stage testing is complete. The European Medicines Agency, Europe’s version of FDA, has signaled it also is open to faster, emergency clearance.

What comes next?

The FDA has pledged that before it decides to roll out any COVID-19 vaccines, its scientific advisers will publicly debate whether there’s enough evidence behind each candidate.

First up on December 10, Pfizer and BioNTech will present data suggesting their vaccine candidate is 95% effective. Moderna said its turn at this “science court” is expected exactly a week later, on December 17.

Rationing initial doses

If the FDA allows emergency use, Moderna expects to have 20 million doses ready for the US by year’s end. Recipients will need two doses, so that’s enough for 10 million people.

Pfizer expects to have 50 million doses globally in December. Half of them — or enough for 12.5 million people — are earmarked for the US.

Israel is reportedly expected to receive up to half a million doses of the Pfizer Inc. vaccine against the coronavirus as early as December, one month earlier than originally hoped for.

The first patient enrolled in Pfizer’s COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, May 4, 2020. (Courtesy of University of Maryland School of Medicine via AP, File)

As part of the agreement with Pfizer, Israel is to receive 8 million doses of the vaccine, enough to inoculate 4 million Israelis.

This week, a different panel of US experts, established by the Centers for Disease Control and Prevention, will meet to decide how initial supplies will be given out. They’re expected to reserve scarce first doses for health care workers and, if the shots work well enough in the frail elderly, for residents of long-term care facilities. As more vaccine gradually becomes available in coming months, other essential workers and people at highest risk from the coronavirus would get in line. But enough for the general population isn’t expected until at least spring.

Outside the US, Zaks said significant supplies from Moderna would be available later, “in the first quarter” of next year.

“Obviously we are doing everything in our power to increase the capacity and accelerate the timelines,” he said.

In this July 27, 2020, photo, a nurse prepares a shot as a study of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., gets underway in Binghamton, New York. (AP Photo/Hans Pennink)

Zaks said earlier this month that Israel would be among the first countries in line to receive the Moderna coronavirus vaccine, as one of the earliest countries to sign a deal with the company. Israel is thought to have purchased 1-2 million doses of the vaccine.

Prime Minister Benjamin Netanyahu first announced in June that Israel had signed a deal with Moderna for its future coronavirus vaccine, without specifying the number of doses that would be supplied. Israel has paid a total of NIS 405 million ($120 million) to the firm, according to the Haaretz daily.

Both Moderna’s and Pfizer’s vaccines are made with the same technology, using a piece of genetic code for the “spike” protein that studs the virus. That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, training immune cells to recognize it if the real virus eventually comes along.

AstraZeneca confusion

AstraZeneca last week announced confusing early results of its vaccine candidate from research in Britain and Brazil.

That vaccine appears 62% effective when tested as originally intended, with recipients given two full doses. But because of a manufacturing error, a small number of volunteers got a lower first dose — and AstraZeneca said in that group, the vaccine appeared to be 90% effective.

A researcher in a laboratory at the Jenner Institute in Oxford, England, works on the coronavirus vaccine developed by AstraZeneca and Oxford University, November 23, 2020. (University of Oxford/John Cairns via AP, File)

Experts say it’s unclear why the lower-dose approach would work better and that it may just be a statistical quirk.

A larger US study of the AstraZeneca candidate still is underway that should eventually give the FDA a better picture of how well it works. The FDA has said any COVID-19 vaccine would have to be at least 50% effective.

Meanwhile Britain’s government will have to decide whether its UK data is sufficient for an early rollout there.

Still in the pipeline

Johnson & Johnson also is in final-stage testing in the US and several other countries to see if its vaccine candidate could work with just one dose.

Both the J&J and AstraZeneca vaccines work by using harmless cold viruses to carry the spike protein gene into the body and prime the immune system.

The different technologies have ramifications for how easily different vaccines could be distributed globally. The AstraZeneca shots won’t require freezer storage like the Pfizer and Moderna vaccines.

Candidates made with still other technologies are in late-stage testing, too. Another US company, Novavax Inc., announced Monday that it has finished enrolling 15,000 people in a late-stage study in Britain and plans to begin recruiting even more volunteers for final testing in the US and Mexico “in the coming weeks.”

Vaccines made by three Chinese companies and a Russian candidate also are being tested in thousands of people in countries around the world.

Israel’s domestically produced coronavirus vaccine will likely be ready for the public by the summer, according to a report earlier this month. However on Monday, the head of the Defense Ministry’s Institute for Biological Research griped that regulation was slowing down testing on the vaccine that it’s developing.

Defense Minister Benny Gantz, left, speaks with the director of the Institute of Biological Research, Prof. Shmuel Shapira, at the laboratory in Ness Ziona on October 19, 2020. (Ariel Hermoni/ Defense Ministry)

Prof. Shmuel Shapira told a Knesset committee that the institute finished stage trials five days ago and was set to begin stage 2 trials within the next 10 days.

“If we hadn’t encountered excess regulation, we would’ve progressed more. We were meant to be in the third stage already and now we’ll only reach it in April,” he was quoted as saying in a statement from the Knesset.

The first phase of clinical trials for the vaccine, called Brilife, began earlier this month.

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