FDA clears Moderna vaccine for COVID-19, 2nd shot in arsenal

The Food and Drug Administration is allowing a second COVID-19 vaccine to be distributed under an Emergency Use Authorization (EUA), stating late Friday evening that Moderna's vaccine data met the necessary requirements.

"This vaccine met the FDA's rigorous standards of quality, safety and efficacy," said FDA Commissioner Dr. Stephen Hahn, who told reporters on a late-night telephone conference that FDA scientists and an independent panel reviewed hundreds of pages of Moderna's trial data.

Moderna issued a statement saying that delivery to the U.S. Government will begin immediately. Moderna says it will provide 20 million doses to the U.S. government within the next two weeks. The company expects another 85 million to100 million doses for the U.S., in the first quarter of 2021.

That will greatly increase the supply of vaccines when combined with Pfizer's vaccine that was rolled out this week.

On Friday, Vice-President Mike Pence, his wife and the U.S. Surgeon General received the Pfizer COVID vaccine, as did Senate Majority Leader Mitch McConnell and House Speaker Nancy Pelosi.

California Governor Gavin Newsom replied on Twitter Friday night, saying the state is expecting Moderna's vaccine soon.

"672,000 doses are expected to arrive in California," said Governor Newsom, adding that California and other western states will review the data independently over the weekend.

Already some Bay Area counties and hospitals say they are preparing for the second vaccine.

In Marin County, a spokeswoman says they are expecting 3,000 doses of the Moderna vaccine, with hospitals in the county also receiving doses.

Santa Clara County officials say they are anticipating a shipment of 39,300 Moderna vaccine doses next Tuesday.

And Sutter Health hospitals say they could receive as many as 35,000 Moderna vaccines in the coming weeks.

The Moderna vaccine uses the same messenger RNA technology as the Pfizer vaccine, which prompts the human body to produce antibodies for SARS-CoV2.

There are differences, however, between the two vaccines.

Moderna's vaccine is approved only for adults 18-years and up, whereas Pfizer's vaccine can be administered to youth 16-years and older.

Moderna's vaccine can be stored in regular freezers and do not need to be diluted, making it easier to distribute.

The Pfizer vaccine needs storage in special ultra-cold freezers and must be thawed and diluted before use.

Both require two doses, and there has been controversy over who should get the vaccines as they become available.
The roll out of the vaccine already has been bumpy and is going to get bumpier. There's going to be lots of frustration about who gets in line," said Dr. John Swartzberg, a UC Berkeley Clinical Professor Emeritus of infectious diseases and vaccinology.

Both vaccines also come with side effects such as soreness, headaches, or in rare cases, allergic reactions.

The FDA says they will be tracking any problems closely.

"We'll be looking at all of the data we can from each of these reactions to sort out exactly what happened," said
Dr. Peter Marks, Director of the FDA Center for Biologics Evaluation and Research.

"The vaccine's known benefits clearly outweigh the known risks," Dr. Marks added.

Even with the two vaccines, health officials say the U.S. will need to have 75-85% of Americans inoculated to achieve herd immunity protection, and that likely won't happen until next summer if production continues smoothly.

Jana Katsuyama is a reporter for KTVU. Email Jana at jana.katsuyama@foxtv.com and follow her on Twitter @JanaKTVU or Facebook @NewsJana or ktvu.com.