The US Food and Drug Administration on Tuesday issued a positively worded briefing document about the Moderna COVID-19 vaccine ahead of a meeting by experts on whether to grant it emergency approval.
The FDA was upbeat on the vaccine, saying there were “no specific safety concerns identified that would preclude issuance of an EUA (emergency use authorization).”
The drug authority said its preliminary analysis confirmed the effectiveness and safety of the vaccine developed by Moderna and the National Institutes of Health, bringing it to the cusp of US authorization.
A panel of outside experts will offer their recommendation Thursday, with a final FDA decision expected soon thereafter.
The positive news comes as vaccination programs have begun in several countries with the shot developed by Pfizer and BioNTech, which the FDA cleared last week.
Moderna’s vaccine is the same type as Pfizer’s, made with the same technology and also requiring two shots for full protection. And in scrutinizing early results of a 30,000-person study, the FDA found it also worked just about the same.
The Moderna vaccine was more than 94% effective overall at preventing COVID-19 illness, and 86% effective in people 65 and older, the FDA said, adding that it had uncovered no major safety issues.
Recipients tend to experience temporary flu-like side effects that can include fever, fatigue and aches, especially after the second dose as the vaccine revs up their immune system.
Even such a large study can’t detect very rare problems. But the FDA looked carefully for signs of allergic reactions after Britain last week reported some possible reactions among people with a history of severe allergies.
The FDA found no serious allergic reactions in the Moderna study. About 1.5% of vaccine recipients and 1.1% who got dummy shots reported possible smaller, “hypersensitivity” reactions.
Both Moderna’s and Pfizer-BioNTech’s shots are so-called mRNA vaccines. They aren’t made with the coronavirus itself, meaning there’s no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.
After initial positive results of clinical trials, Israel signed an agreement with Moderna earlier this month to triple the number of coronavirus inoculations the American pharmaceutical company will supply. The original agreement for two million doses was expanded to six million — enough for three million Israelis.
“This gives us hope; we see the light at the end of the tunnel,” Prime Minister Benjamin Netanyahu said in a statement announcing the move.
If approved by the FDA, vaccines are to arrive in Israel at the end of December or early January, the Ynet news reported at the time. However, Moderna’s Israeli chief medical officer Dr. Tal Zacks told Channel 12 that they expected to get approval by the end of December and that most of the vaccines would come “toward the end of winter, beginning of spring” after the company ramps up production.
The Health Ministry on Monday told health maintenance organizations that Israel’s COVID-19 vaccination drive will kick off next week, with members of the general public to begin receiving Pfizer vaccinations on December 23. Israel currently has 313,000 doses of Pfizer’s coronavirus vaccine and is expected to have 3.8 million by the end of December, according to Channel 12 news.