Moderna asking U.S., European regulators to approve its virus shots

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Doctors Say CDC Should Warn People About COVID-19 Vaccine Side Effects . Now that Pfizer, Moderna and AstraZeneca are each closer to releasing a COVID-19 vaccine to the public, . doctors are urging the CDC to let people know that it is possible they will experience unpleasant side effects. Since each of the drugmakers' vaccines require two separate doses, . Dr. Sandra Fryhofer of the American Medical Association is worried people won't return for the second dose after experiencing side effects from the first dose. We really need to make patients aware that this is not going to be a walk in the park, Dr. Sandra Fryhofer of the American Medical Association, via statement. They are going to know they had a vaccine. They are probably not going to feel wonderful. But they’ve got to come back for that second dose, Dr. Sandra Fryhofer of the American Medical Association, via statement. One Moderna study participant in her 50s said she endured a migraine that left her drained and unable to focus for an entire day. The first dose is no big deal. And then the second dose will definitely put you down for the day for sure. ... You will need to take a day off after the second dose, Moderna COVID-19 vaccine study participant, via CNBC. Possible side effects include body aches, chills, high fever, bad headaches, daylong exhaustion and more

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.

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Moderna is just behind Pfizer and its German partner BioNTech in seeking to begin vaccinations in the U.S. in December. Across the Atlantic, British regulators also are assessing the Pfizer shot and another from AstraZeneca.

Emory University infectious disease expert Dr. Carlos del Rio said Monday it was extraordinary how quickly the vaccine has been developed and appears to be on the verge of having tens of millions of vaccine doses ready to go less than a year from the time the new coronavirus was first identified.

”As Americans, we all need to be very proud of what has been accomplished,” del Rio said at an online press conference. “It is simply something we have never seen before, and again it shows how industry, government, scientists and community have partnered to make this possible. It really shows the impossible is actually possible.”

Del Rio said he believes we are on track for one or more COVID-19 vaccines to be widely distributed by next summer – sometime between May and July.

Emory has been a major participant in the trial. About 700 of the approximately 30,000 trial participants were involved in the study through Emory. Its Phase 3 study began on Aug. 11 and concluded Oct. 23.

Moderna might have an edge over Pfizer when it comes to temperature requirements for storage and distribution. Pfizer needs to be kept extremely cold: minus 70 degrees Celsius. Moderna has said its vaccine needs to be frozen, too, but only at minus 20 Celsius, more like a regular freezer.

And the Moderna vaccine can be stored in the temperature of a standard home or medical refrigerator for 30 days.

Del Rio said the less extreme storage requirements could help with widespread distribution particularly at pharmacies and grocery stores as well as rural areas which are likely not to have the capability for ultra-cold chain storage.

Many questions remain. Scientists don’t yet know whether people who are vaccinated can still get infected and remain without symptoms but still be able to spread the virus to others.

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 the FDA, has signaled 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 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.

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 one dose.

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.

Helena Oliviero of The Atlanta Journal-Constitution contributed to this report.