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

Just Posted

From left: Thomas Kuecks, David Lane, John Ivison, Denis Berger, Rod Gray, and James Kuecks are Cabin Fever. Catch their performance on the Cowichan Performing Arts Centre website. (Ashley Foot photo)
A&E column: Music Festival winners, CVAC awards, and Cabin Fever

The latest from the Cowichan Valley arts and entertainment community

BC Green Party leader and Cowichan Valley MLA Sonia Furstenau introduced a petition to the provincial legislature on Thursday calling for the end of old-growth logging in the province. (File photo)
Cowichan Valley MLA Furstenau introduces old-growth logging petition

BC Green Party calls for the end of old-growth logging as protests in Fairy Creek continue

The city-owned lot at 361 St. Julien St., which has been home to a temporary homeless site for more than a year, will be sold and plans are to build a three-storey mixed-use development there, Peter de Verteuil, Duncan CAO explained at a recent council meeting. (File photo)
New development planned for homeless site in Duncan

Lot on St. Julien Street would see three-storey building

Historian and longtime Citizen columnist T.W. Paterson photographs the historical wreckage of a plane on Mount Benson. Paterson recently won an award from the British Columbia Historical Foundation. (Submitted)
Cowichan’s Tom W. Paterson wins award for historical writing

British Columbia Historical Federation hands Recognition Award to local writer

This electric school bus is the newest addition to the Cowichan Valley School District’s fleet. (Submitted)
Editorial: New electric school bus good place to start

Changing public transit like buses to electric really is important.

People line up to get their COVID-19 vaccine at a vaccination centre, Thursday, June 10, 2021 in Montreal. THE CANADIAN PRESS/Ryan Remiorz
Vaccines, low COVID case counts increase Father’s Day hope, but risk is still there

Expert says people will have to do their own risk calculus before popping in on Papa

The Co-op gas station at Whiskey Creek is burning after a camper van exploded while refueling just before 4 p.m. on Thursday, June 17, 2021. (FACEBOOK PHOTO)
Exploding camper van torches Highway 4 gas station between Qualicum Beach and Port Alberni

Highway traffic blocked after Whiskey Creek gas station erupts into flames

Helen Austin performing with Trent Freeman at the 2018 Vancouver Island MusicFest. Austin is one of the many performers listed for the 2021 event.
Vancouver Island MusicFest goes virtual for 2021

Black Press to stream 25 hours of programming July 9-11

Greater father involvement in the home leads to improved childhood development and increased marital satisfaction, says expert. (Black Press Media file photo)
Vancouver Island researcher finds lack of father involvement a drag on gender equality

Working women still taking on most child and household duties in Canada: UVic professor

FILE – A science class at L.A. Matheson Secondary in Surrey, B.C. on March 12, 2021. (Lauren Collins/Surrey Now Leader)
Teachers’ union wants more COVID transmission data as B.C. prepares for back-to-school

BCTF says that details will be important as province works on plan for September

Provincial health officer Dr. Bonnie Henry outlines B.C.’s COVID-19 restart plan, May 25, 2021, including larger gatherings and a possible easing of mandatory masks on July 1. (B.C. government photo)
B.C. records 120 new COVID-19 cases, second vaccines accelerating

Lower Pfizer deliveries for early July, Moderna shipments up

A Heffley Creek peacock caught not one - but two - lifts on a logging truck this month. (Photo submitted)
Heffley Creek-area peacock hops logging trucks in search of love

Peacock hitched two lifts in the past month

The Calgary skyline is seen on Friday, Sept. 15, 2017. THE CANADIAN PRESS/Jeff McIntosh
2 deaths from COVID-19 Delta variant in Alberta, 1 patient was fully immunized

Kerry Williamson with Alberta Health Services says the patients likely acquired the virus in the hospital

The first suspension bridge is the tallest in Canada, with a second suspension bridge just below it. The two are connected by a trail that’s just over 1 km. (Claire Palmer photo)
PHOTOS: The highest suspension bridges in Canada just opened in B.C.

The Skybridge in Golden allows visitors to take in views standing at 130 and 80 metres

Most Read