FILE - In this July 27, 2020, file photo, nurse Kathe Olmstead prepares a shot that is part of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., in Binghamton, N.Y. Moderna Inc. says it will ask U.S. and European regulators to allow emergency use of its COVID-19 vaccine as new study results confirm the shots offer strong protection. (AP Photo/Hans Pennink, File)

VIDEO: Moderna asking US, European regulators to OK its virus shots

Moderna created its shots with the U.S. National Institutes of Health and already had a hint they were working

Moderna Inc. said it would ask U.S. and European regulators Monday to allow emergency use of its COVID-19 vaccine as new study results confirm the shots offer strong protection — ramping up the race to begin limited vaccinations as the coronavirus rampage worsens.

Multiple vaccine candidates must succeed for the world to stamp out the pandemic, which has been on the upswing in the U.S. and Europe. U.S. hospitals have been stretched to the limit as the nation has seen more than 160,000 new cases per day and more than 1,400 daily deaths. Since first emerging nearly a year ago in China, the virus has killed more than 1.4 million people worldwide.

Moderna is one of several companies to have already submitted partial data to a “rolling review” process offered by Health Canada. Rather than presenting regulators with a complete package of trial results, the would-be vaccine-makers file data and findings as they become available. Canada has been looking at Moderna’s first results since mid-October.

Canada has a different approval process than the United States and European countries, meaning that Moderna and Pfizer do not have to apply or reapply at each step. Instead, they have to submit their newest data and findings.

Moderna created its shots with the U.S. National Institutes of Health and already had a hint they were working, but said it got the final needed results over the weekend that suggest the vaccine is more than 94% effective.

Of 196 COVID-19 cases so far in its huge U.S. study, 185 were trial participants who received the placebo and 11 who got the real vaccine. The only people who got severely ill — 30 participants, including one who died — had received dummy shots, said Dr. Tal Zaks, the Cambridge, Massachusetts, company’s chief medical officer.

When he learned the results, “I allowed myself to cry for the first time,” Zaks told The Associated Press. “We have already, just in the trial, have already saved lives. Just imagine the impact then multiplied to the people who can get this vaccine.”

Moderna said the shots’ effectiveness and a good safety record so far — with only temporary, flu-like side effects — mean they meet requirements set by the U.S. Food and Drug Administration for emergency use before the final-stage testing is complete. The European Medicines Agency, Europe’s version of FDA, has signalled it also is open to faster, emergency clearance.

WHAT COMES NEXT

The FDA has pledged that before it decides to roll out any COVID-19 vaccines, its scientific advisers will publicly debate whether there’s enough evidence behind each candidate.

First up on Dec. 10, Pfizer and BioNTech will present data suggesting their vaccine candidate is 95% effective. Moderna said its turn at this “science court” is expected exactly a week later, on Dec. 17.

RATIONING INITIAL DOSES

If the FDA allows emergency use, Moderna expects to have 20 million doses ready for the U.S. by year’s end. Recipients will need two doses, so that’s enough for 10 million people.

Pfizer expects to have 50 million doses globally in December. Half of them — or enough for 12.5 million people — are earmarked for the U.S.

This week, a different panel of U.S. experts, established by the Centers for Disease Control and Prevention, will meet to decide how initial supplies will be given out. They’re expected to reserve scarce first doses for health care workers and, if the shots work well enough in the frail elderly, for residents of long-term care facilities. As more vaccine gradually becomes available in coming months, other essential workers and people at highest risk from the coronavirus would get in line. But enough for the general population isn’t expected until at least spring.

Outside the U.S., Zaks said significant supplies from Moderna would be available later, “in the first quarter” of next year.

“Obviously we are doing everything in our power to increase the capacity and accelerate the timelines,” he said.

READ MORE: Moderna chairman says Canada near head of line for 20 million vaccine doses

Both Moderna’s and Pfizer’s vaccines are made with the same technology, using a piece of genetic code for the “spike” protein that studs the virus. That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, training immune cells to recognize it if the real virus eventually comes along.

ASTRAZENECA CONFUSION

AstraZeneca last week announced confusing early results of its vaccine candidate from research in Britain and Brazil

That vaccine appears 62% effective when tested as originally intended, with recipients given two full doses. But because of a manufacturing error, a small number of volunteers got a lower first dose — and AstraZeneca said in that group, the vaccine appeared to be 90% effective.

Experts say it’s unclear why the lower-dose approach would work better and that it may just be a statistical quirk.

A larger U.S. study of the AstraZeneca candidate still is underway that should eventually give the FDA a better picture of how well it works. The FDA has said any COVID-19 vaccine would have to be at least 50% effective.

Meanwhile Britain’s government will have to decide whether its U.K. data is sufficient for an early rollout there.

STILL IN THE PIPELINE

Johnson & Johnson also is in final-stage testing in the U.S. and several other countries to see if its vaccine candidate could work with just one dose.

Both the J&J and AstraZeneca vaccines work by using harmless cold viruses to carry the spike protein gene into the body and prime the immune system.

The different technologies have ramifications for how easily different vaccines could be distributed globally. The AstraZeneca shots won’t require freezer storage like the Pfizer and Moderna vaccines.

Candidates made with still other technologies are in late-stage testing, too. Another U.S. company, Novavax Inc., announced Monday that it has finished enrolling 15,000 people in a late-stage study in Britain and plans to begin recruiting even more volunteers for final testing in the U.S. and Mexico “in the coming weeks.”

Vaccines made by three Chinese companies and a Russian candidate also are being tested in thousands of people in countries around the world.

____

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Lauran Neergaard, The Associated Press


Like us on Facebook and follow us on Twitter.

Want to support local journalism during the pandemic? Make a donation here.

Coronavirusvaccines

Get local stories you won't find anywhere else right to your inbox.
Sign up here

Just Posted

This image shows the Kitsumkalum community hall. The First Nation is about to head to the polls to elect a new council. (Brittany Gervais/Terrace Standard)
All-candidates forum planned for Kitsumkalum election

Virtual meeting set for evening of Feb. 8

Kitselas First Nation received a round of COVID-19 vaccine shots. (Kitselas First Nation image)
Kitselas receives COVID-19 vaccine

Delivery of vaccine was expedited after cluster of cases in community

Northern Health has issued COVID-19 exposure notices for Uplands Elementary School and Centennial Christian School in Terrace. (COVID-19/ CDC Image)
Two more COVID-19 exposure notices issued for schools in Terrace

Exposures took place at Uplands Elementary School and Centennial Christian School

People skate on a lake in a city park in Montreal, Sunday, January 10, 2021. THE CANADIAN PRESS/Graham Hughes
The end of hugs: How COVID-19 has changed daily life a year after Canada’s 1st case

Today marks the one year anniversary of COVID-19 landing in Canada

Dr. Penny Ballem, a former deputy health minister, discusses her role in leading B.C.’s COVID-19 vaccination program, at the B.C. legislature, Jan. 22, 2021. (B.C. government)
B.C. holds steady with 407 new COVID-19 cases Tuesday

14 deaths, no new outbreaks in the health care system

(Kraft Dinner/Twitter)
Kraft Dinner launches candy-flavoured mac and cheese just in time for Valentine’s Day

Sweet and cheesy treat will be here just in time for the cheesiest holiday of the year

SAR crews worked late into the night Tuesday to rescue an injured snowboarder in North Vancouver. (Facebook/North Shore Rescue)
Complicated, dangerous rescue saves man in avalanche near Cypress Mountain

North Shore SAR team braves considerable conditions to reach injured snowboarder

A Cessna 170 airplane similar to the one pictured above is reported to be missing off the waters between Victoria and Washington State. Twitter photo/USCG
UPDATE: No sign of small plane that went down in waters south of Vancouver Island

Searchers out on both sides of border between Victoria and Port Angeles

In this undated image made from a video taken by the Duke of Sussex and posted on @SaveChildrenUK by the Duke of Sussex and Meghan, Duchess of Sussex, shows the Duchess of Sussex reading the book “Duck! Rabbit!” to their son Archie who celebrates his first birthday on Wednesday May 6, 2020. The Canadian Paediatric Society is reminding families that the process of raising a reader starts from birth. (Duke of Sussex/@SaveChildrenUK)
Canadian Paediatric Society says raising a reader starts from birth

CPS says literacy is one of the strongest predictors of lifelong health outcomes

Employment, Workforce Development and Disability Inclusion Minister Carla Qualtrough responds to a question during a news conference Thursday August 20, 2020 in Ottawa. THE CANADIAN PRESS/Adrian Wyld
Easing rules for parental benefits created inequities among parents, documents say

Employment Minister Carla Qualtrough’s office says the government will make any necessary changes

People walk along a pedestrianized zone of Sainte-Catherine street in Montreal, Monday, May 18, 2020, as the COVID-19 pandemic continues in Canada and around the world. Newly released statistics point to a major drop in police-recorded crime during the first eight months of the COVID-19 pandemic. THE CANADIAN PRESS/Graham Hughes
Crime down in first 8 months of pandemic, but mental health calls rise: StatCan

The agency says violent crimes such as assault dropped significantly

Cowichan Tribes chief Squtxulenhuw (William Seymour) confirmed the first death in the First Nations community from COVID-19. (File photo)
Cowichan Tribes confirms 1st death amid growing COVID-19 outbreak

Shelter-in-place order has been extended to Feb. 5

(Pixabay)
B.C. teacher gets 1 day suspension after ‘aggressively’ throwing dumbbell at student

Documents show the weight would have hit the student if they didn’t catch it

Most Read