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Moderna expected to announce early COVID vaccine results this month

US biotech giant, which has a contract with Israel to supply coronavirus shots when developed, could apply for emergency FDA approval in early December

A nurse gives a volunteer an injection, as the world's biggest study of a possible COVID-19 vaccine, developed by the US National Institutes of Health and Moderna Inc., gets underway on July 27, 2020, in Binghamton, NY. (AP Photo/Hans Pennink)
A nurse gives a volunteer an injection, as the world's biggest study of a possible COVID-19 vaccine, developed by the US National Institutes of Health and Moderna Inc., gets underway on July 27, 2020, in Binghamton, NY. (AP Photo/Hans Pennink)

US biotech firm Moderna is expected to release preliminary data on the effectiveness of its coronavirus vaccine later this month, the company said Wednesday, two days after competitor Pfizer touted the overwhelming success rate of its experimental COVID-19 shot.

Pfizer announced Monday that initial data indicated the vaccine it is developing with German partner BioNTech is 90 percent effective at preventing COVID-19, sparking optimism inoculations against the novel coronavirus could soon be available.

Moderna — which has agreed to supply COVID-19 vaccines to Israel — said Wednesday it could apply for emergency FDA approval by early December after releasing more information on its effectiveness, expected later this month, according to the Reuters news agency.

Its Chief Executive Officer Stephane Bancel said it was currently too early to gauge how effective the vaccine would be, the report said.

Moderna has enrolled 30,000 people in its phase 3 trial, half of whom have been given a placebo. It says it needs 151 cases to trigger a formal efficacy analysis, though preliminary analyses will be done after 53 and 106 cases.

A nurse gives a volunteer an injection as part of a study of a possible COVID-19 vaccine, developed by the US National Institutes of Health and Moderna Inc., in Binghamton, New York, July 27, 2020. (Hans Pennink/AP)

The FDA is requiring that companies track at least half of study volunteers for two months to look for side effects before asking the agency to review their vaccine. That’s about when side effects have cropped in studies of other vaccines. Pfizer and Moderna both expect to reach that safety milestone later in November.

Manufacturers already have begun stockpiling vaccine doses in anticipation of eventual approval, but the first shots will be in short supply and rationed. And the first people vaccinated will need to undergo extra safety tracking, as the government watches for rare side effects that might crop up when the shots are given to many more people than were in the research studies.

Pfizer’s announcement on Monday, which put the company on track to apply later this month for emergency-use approval from the US Food and Drug Administration, was hailed Monday by Prime Minister Benjamin Netanyahu, who vowed to bring the vaccine to Israel.

Pfizer headquarters in New York City, on November 9, 2020. (David Dee Delgado/Getty Images/AFP)

But health officials are reportedly concerned Israel may have missed the chance to promptly acquire the COVID-19 vaccine from Pfizer, according to a report Wednesday.

Pfizer expects to produce 50 million doses this year and 1.3 billion in 2021: The United States has already ordered 100 million total including 20-30 million for delivery before the end of December. The European Union meanwhile has ordered 200 million, Japan 120 million, Britain 30 million and Canada 20 million.

Moderna, AstraZeneca, Johnson & Johnson, Sanofi and others are hoping their own vaccines will also prove safe and effective, and their global rollout will follow suit.

Should Moderna’s version prove to be similarly effective, logistical concerns may make it more attractive than Pfizer’s for countries such as Israel. The Pfizer vaccine must be stored at -94 degrees Fahrenheit (-70 degrees Celsius), whereas the Moderna model can be stored at -4 degrees Fahrenheit, the temperature of a normal freezer.

Israel has already paid a total of NIS 405 million ($120 million) to Moderna and Arcturus, which is at an early stage in testing, out of NIS 1 billion set aside for purchasing vaccines, according to the Haaretz daily.

In addition, Israel has inked a deal with Italian biotech firm ReiThera to supply a vaccine if and when developed. Israel has also reportedly been in contact with Russia and China to possibly use their vaccines if they prove effective, with a Jerusalem hospital ordering 1.5 million doses of the Russian shot in case trials eventually show it to be safe.

On Wednesday, Russia announced that its vaccine was 92% effective.

Israel is also developing its own vaccine, albeit at a slower pace, with human trials beginning last week.

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