12.18.20

'Early Christmas present': FDA clears Moderna vaccine, 6M doses on way

The Food and Drug Administration approved Moderna‘s coronavirus vaccine for emergency use on Friday, clearing the way for an immediate shipment of 6 million doses on top of the Pfizer vaccine that’s already in use.

No one’s happier about it than Sen. Steve Daines.

Back in March, as the coronavirus hit and Congress scrambled to cut checks to struggling Americans, the Montana Republican was looking months down the road. What if the virus didn’t go away as it got warmer, and the only way out was through a vaccine?

After a 13-year career at Proctor and Gamble, Mr. Daines knew that companies weren’t going to spend big on a product that might not get approved by the Food and Drug Administration. He asked Sen. Roy Blunt, who oversees health matters on the Senate Appropriations Committee, for $10 billion to help companies develop vaccines and start making doses before regulators weighed in.

“That was a pretty big ask at the time,” Mr. Daines told The Washington Times. “Many believed the pandemic was going to end by the summer. But many feared a second wave, including myself, and that’s what we’ve seen." 

Mr. Daines‘ request made it into the $2 trillion CARES Act.

Now, the senator believes the pandemic will start to wind down within six months. Without early manufacturing, he believes the world wouldn’t have seen the first vaccines until mid-2021.

“It’s remarkable. Nobody thought we would have an approved vaccine and see Americans vaccinated by the end of the calendar year,” he said. “I view this as an early Christmas present that we were able to give to the American people.”

Pfizer didn’t accept federal money for the development of its vaccine but the Trump administration spent nearly $2 billion to secure early doses.

Moderna, a smaller company, did accept federal help and worked with the National Institutes of Health on its vaccine. Companies like AstraZeneca and Johnson and Johnson were also boosted by Mr. Daines‘ push and President Trump’s vaccine initiative, Operation Warp Speed.

Mr. Blunt credited Mr. Daines for leveraging his background in manufacturing and business. The Missouri Republican said the simultaneous review and manufacturing was a “significant step toward vaccines being available for the American public in under one year.”

Moderna CEO Stephane Bancel also said he is grateful for Mr. Daines‘ “full commitment in this fight against covid-19 through scientific innovation.”

Moderna‘s vaccine, like Pfizer’s, uses “messenger RNA” to teach the body to fight the coronavirus by making imposters of its trademark spike protein. The snippets of genetic code are delivered in bubbles of fat known as a lipid nanoparticle.

The shots from Moderna can last in a refrigerator for up to a month. Pfizer’s degrade after five days in a normal fridge, so they need to be packed in special boxes with replenishments of dry ice for up to 15 days if they’re not used immediately.

Initial deliveries of the Moderna vaccine will be sent to the states through Wednesday.

“Congratulations, the Moderna vaccine is now available!” Mr. Trump tweeted.

Federal officials are trying to boost confidence in the shots so the country can build up the type of widespread immunity needed to break the pandemic.

Vice President Mike Pence and Second Lady Karen Pence received their shots publicly on Friday.

“Karen and I wanted to step forward and take this vaccine to assure the American people that while we cut red tape, we cut no corners,” Mr. Pence said at the White House event.

President-elect Joseph R. Biden plans to get the vaccine Monday, and Congress‘ physician told members they’re eligible as part of continuity of government operations.

House Speaker Nancy Pelosi tweeted photos of her receiving the shot on Friday. She reminded Americans to maintain COVID-19 precautions while the nation works to “crush the virus.”

Mr. Daines took part in Pfizer’s vaccine trial this year after his mother told him about enrollment back home in Bozeman, Montana. It was a hotspot at the time, and scientists wanted to make sure they were testing the vaccine in places with transmission.

The senator said the injection felt a lot like taking the flu shot. He’s pretty sure he got the real thing, not a placebo, because he tested positive for antibodies later on.

He said the vaccine is clearly effective, including for seniors that are most vulnerable to COVID-19.

“Hope is not a strategy,” he said. “A vaccine and widespread adoption of the vaccine is a strategy that’s going to end the pandemic.”


By:  Tom Howell Jr.
Source: Washington Times