Please ensure Javascript is enabled for purposes of website accessibility
2nd COVID-19 Vaccine Set for OK in US With Panel Endorsement
gvw_ap_news
By Associated Press
Published 4 years ago on
December 17, 2020

Share

WASHINGTON — A government advisory panel endorsed a second COVID-19 vaccine Thursday, paving the way for the shot to be added to the U.S. vaccination campaign.

The Food and Drug Administration is expected to follow the recommendation for the vaccine from Moderna and the National Institutes of Health. The FDA advisers, in a 20-0 vote, agreed the benefits of the vaccine outweighed the risks for those 18 years old and up.

The FDA’s green light for emergency use is expected quickly. Moderna would then begin shipping millions of doses, earmarked for health workers and nursing home residents, to boost the largest vaccination effort in U.S. history.

The campaign kicked off earlier this week with the first vaccine OK’d in the U.S., developed by Pfizer and BioNTech. Moderna’s shot showed similarly strong protection, providing 94% protection against COVID-19 in the company’s ongoing study of 30,000 people.

After seven hours of debate over technical details of the company’s study and follow-up plans, nearly all panelists backed making the vaccine available to help fight the pandemic. One panel member abstained.

“The evidence that has been studied in great detail on this vaccine highly outweighs any of the issues we’ve seen,” said Dr. Hayley Gans of Stanford University Medical Center.

A second vaccine is urgently needed as coronavirus infections, hospitalizations and deaths climb to new highs ahead of the holidays. The U.S. leads the world in virus totals, with more than 1.6 million confirmed cases and nearly 309,000 reported deaths.

Moderna’s vaccine uses the same groundbreaking technology as Pfizer-BioNTech’s shot. Most traditional vaccines use dead or weakened virus, but both of the new vaccines use snippets of COVID-19’s genetic code to train the immune system to detect and fight the virus. Both require two doses, several weeks apart.

While the Two Vaccines Use the Same Technology, They’re Not Identical

Thursday’s review came days after reports of apparent allergic reactions to the Pfizer-BioNTech vaccine in two Alaska health workers. One person had a severe reaction, including shortness of breath, the other had less serious side effects, including lightheadedness.

While the two vaccines use the same technology, they’re not identical, cautioned Moderna chief medical officer Dr. Tal Zaks. In particular, some of the lipids, or fats, used to coat the two vaccines are different.

“I would not necessarily assume” that any reactions would be the same, he said.

The FDA found no severe allergic reactions in Moderna’s data but flagged a slightly higher rate of less serious side effects — rash, hives, itching — among participants who got the vaccine, compared with those receiving a dummy shot.

There were also three cases of Bell’s palsy, which temporarily paralyzes facial muscles, among vaccine recipients, compared with just one among those getting a dummy shot. The FDA review said the role of the shot in the vaccine group “cannot be ruled out.”

An unanswered question is whether the vaccine also prevents people from symptomless infection – but Moderna found a hint that it may. Study participants had their noses swabbed prior to the second dose of either vaccine or placebo. At that one timepoint, swabs from 14 vaccine recipients and 38 placebo recipients showed evidence of asymptomatic infection, said Moderna’s Dr. Jacqueline Miller.

After the FDA acts, U.S. officials plan to move out an initial shipment of nearly 6 million Moderna doses. The vaccine needs to be stored at regular freezer temperatures, but not the ultra-cold required for Pfizer-BioNTech’s shot.

Hundreds of millions of additional shots will be needed to eventually vaccinate the general public, which isn’t expected until the spring or summer. The government’s Operation Warp Speed program has orders for 200 million doses of Moderna’s vaccine. That’s on top of 100 million doses of the Pfizer-BioNTech vaccine. Officials are negotiating to purchase more doses of that vaccine.

Most Panelists Acknowledged It Will Be Hard to Keep Volunteers From Leaving the Moderna Study

Like the first vaccine, Moderna’s vaccine will remain experimental as the company continues a two-year study needed to answer key questions, including how long protection lasts.

One of the trickiest issues panelists debated was how to keep study volunteers who received a dummy shot from dropping out to get the real shot once its authorized. Their participation is critical in order to have a comparison for long-term safety and effectiveness.

Moderna proposed immediately alerting all those volunteers of their status and offering them the vaccine. The company said more than 25% of its participants are health workers and some are already leaving to get the first vaccine.

But an invited expert from Stanford University urged Moderna to adopt Pfizer’s approach. Pfizer plans to gradually vaccinate people in its placebo group based on when they would have normally had access to the vaccine, as priority groups are established.

But most panelists acknowledged it will be hard to keep volunteers from leaving the Moderna study if they have to wait to get the vaccine.

“The reality may make that too difficult to do,” said Dr. Steven Pergam of the Seattle Cancer Care Alliance.

The only COVID-19 death in the 30,000 volunteers was in a placebo recipient, a 54-year-old man whose only risk factor was diabetes.

Knowing there could be more severe coronavirus in placebo recipients as the pandemic continues “weighs heavily on me,” said Moderna’s Miller.

RELATED TOPICS:

DON'T MISS

Voting Rights Under Fire in Texas: Over a Million Purged From Rolls, ACLU Warns

DON'T MISS

Bettors Banking on Eagles Resurgence, Cowboys Regression as NFL Season Begins

DON'T MISS

Abandoned Poodle Mix Adam Survives the Wild and Seeks a Forever Home

DON'T MISS

Labor Day Quiz: What Did Elvis Do Before He Was the ‘King of Rock ‘n’ Roll’?

DON'T MISS

Why Black Students Are Still Disciplined at Higher Rates: Takeaways From AP’s Report

DON'T MISS

Top Brazilian Judge Orders Suspension of X Platform in Brazil Amid Feud With Musk

DON'T MISS

Trump Reverses Course, Opposes Florida Abortion Rights Measure After Conservative Backlash

DON'T MISS

How a Real Estate Boom Drove Political Corruption in Los Angeles

DON'T MISS

Big Red Church Hosts Forum on Palestine on Saturday Night

DON'T MISS

Palestinian TikTok Star Who Shared Details of Gaza Life Under Siege Is Killed by Israeli Airstrike

UP NEXT

Harris Surges Ahead of Trump in Poll, Gains Support from Women and Hispanics

UP NEXT

California Treasurer Fiona Ma Cleared of Sexual Harassment Allegations

UP NEXT

Grand Canyon Visitors Move to Hotels Outside the Park After Unprecedented Breaks in Water Pipeline

UP NEXT

Latinas Are the New Driving Force in US Economy: Study

UP NEXT

Arlington Cemetery Official Was ‘Pushed Aside’ in Trump Staff Altercation but Won’t Press Charges

UP NEXT

FAA Grounds SpaceX After Rocket Falls Over in Flames at Landing

UP NEXT

How Much Will Interest Rates Drop? Wells Fargo Expert Predicts a Sharp Decline by December

UP NEXT

Trump Claims God as His Ally After Surviving Assassination Attempt

UP NEXT

French Prosecutors Say Telegram Messaging App CEO Has Been Freed From Custody, Will Appear in Court

UP NEXT

Navy Recruiting Rebounds, but It Will Miss Its Target to Get Sailors Through Boot Camp

Labor Day Quiz: What Did Elvis Do Before He Was the ‘King of Rock ‘n’ Roll’?

9 hours ago

Why Black Students Are Still Disciplined at Higher Rates: Takeaways From AP’s Report

10 hours ago

Top Brazilian Judge Orders Suspension of X Platform in Brazil Amid Feud With Musk

21 hours ago

Trump Reverses Course, Opposes Florida Abortion Rights Measure After Conservative Backlash

21 hours ago

How a Real Estate Boom Drove Political Corruption in Los Angeles

23 hours ago

Big Red Church Hosts Forum on Palestine on Saturday Night

23 hours ago

Palestinian TikTok Star Who Shared Details of Gaza Life Under Siege Is Killed by Israeli Airstrike

23 hours ago

Valley PBS Taps Mollison to Be New President/CEO

24 hours ago

Farber Campus Opening: ‘Where Students’ Dreams Can Flourish and Not Wither’

24 hours ago

Visalia Rawhide and City Agree on Terms to Upgrade Stadium

1 day ago

Voting Rights Under Fire in Texas: Over a Million Purged From Rolls, ACLU Warns

Texas Gov. Greg Abbott announced the removal of over one million voters from state rolls since 2020, sparking concern among voting rights ad...

4 hours ago

4 hours ago

Voting Rights Under Fire in Texas: Over a Million Purged From Rolls, ACLU Warns

8 hours ago

Bettors Banking on Eagles Resurgence, Cowboys Regression as NFL Season Begins

A black poodle's face with his tongue sticking out
9 hours ago

Abandoned Poodle Mix Adam Survives the Wild and Seeks a Forever Home

9 hours ago

Labor Day Quiz: What Did Elvis Do Before He Was the ‘King of Rock ‘n’ Roll’?

10 hours ago

Why Black Students Are Still Disciplined at Higher Rates: Takeaways From AP’s Report

21 hours ago

Top Brazilian Judge Orders Suspension of X Platform in Brazil Amid Feud With Musk

21 hours ago

Trump Reverses Course, Opposes Florida Abortion Rights Measure After Conservative Backlash

23 hours ago

How a Real Estate Boom Drove Political Corruption in Los Angeles

MENU

CONNECT WITH US

Search

Send this to a friend