Moderna Asks US, EU to OK Virus Shots 11/30 06:21

Moderna Asks US, EU to OK Virus Shots  11/30 06:21

   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.

   (AP) -- 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 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.

   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 signaled it also is open to faster, emergency clearance.


   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.


   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.

   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 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.


   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.



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