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Moderna urges U.S. and European regulators to approve virus attacks

Moderna Inc. announced on Monday that it would request US and European regulators to permit emergency use of the COVID-19 vaccine. This is because new research results confirm that shots provide a strong defense.

Multiple vaccine candidates must succeed in order for the world to eradicate the rising pandemic in the United States and Europe. Hospitals in the United States are reaching their limits with more than 160,000 new cases per day and more than 1,400 deaths per day in the United States. Since its first appearance in China almost a year ago, the virus has killed more than 1.4 million people worldwide.

Moderna is right behind Pfizer and its German partner BioNTech, which is about to begin vaccination in the United States in December. Across the Atlantic, British regulators are also evaluating Pfizer shots and another shot from AstraZeneca.

Modena made a shot at the National Institutes of Health and had a hint that they were already working, but the final desired result on the weekend suggesting that the vaccine is more than 94% effective. I said I got it.

Of the 196 COVID-19 cases to date in a large study in the United States, 185 were placebo-treated study participants and 11 were actually vaccinated. Dr. Tal Sachs, chief medical officer of the company in Cambridge, Massachusetts, said the only seriously ill people (30 participants, including those who died) received dummy shots.

“I allowed myself to cry for the first time,” Sachs told The Associated Press when he learned of the results. “We are already saving lives at the trial stage. Imagine the impact on those who can get this vaccine.”

Moderna has set shot efficacy and good safety records to date (only temporary flu-like side effects) by the U.S. Food and Drug Administration for emergency use before final-stage testing is complete. He said it means meeting the requirements. The European Medicines Agency, the European version of the FDA, has suggested accepting faster emergency clearances as well.

What’s coming next

The FDA has promised that its scientific advisor will publicly discuss whether there is sufficient evidence behind each candidate before deciding to deploy the COVID-19 vaccine.

First, on December 10, Pfizer and BioNTech will present data suggesting that vaccine candidates are 95% effective. Moderna said the turn at the “Science Court” is scheduled for December 17, just a week later.

Initial dose distribution

If the FDA permits emergency use, Moderna expects to be able to administer 20 million doses in the United States by the end of the year. Recipients will need to take two doses, which is sufficient for 10 million people.

Pfizer plans to administer 50 million doses worldwide in December.Half of them (or enough for 12.5 million people) are allocated to the United States

This week, another panel of US experts established by the US Centers for Disease Control and Prevention will meet to determine how the initial supply will be distributed. They are expected to book a rare first dose for healthcare professionals, and if the shots work well in the frail elderly, for residents of care facilities. As more vaccines become increasingly available in the coming months, other essential workers and people at the highest risk of coronavirus will line up. But at least until spring, nothing is expected to be enough for the general public.

Outside the United States, Mr. Sachs said important supplies from Moderna will be available in the “first quarter” of next year.

“Obviously, we’re doing our best to increase capacity and accelerate the timeline,” he said.

Both Moderna and Pfizer vaccines are made using the same technology and use the genetic code of the virus-studded “spike” protein. The messenger RNA, or mRNA, directs the body to make harmless spike proteins and trains immune cells to recognize when the actual virus finally arrives.

AstraZeneca’s turmoil

AstraZeneca released confusing early results of vaccine candidates from studies in the UK and Brazil last week.

The vaccine appears to be 62% effective when the recipient is given two full doses and tested as originally intended. However, due to manufacturing errors, a small number of volunteers reduced their initial dose — and AstraZeneca said the vaccine appeared to be 90% effective in that group.

Experts say it’s unclear why the low-dose approach is more effective, and it may just be a statistical habit.

A larger US study of candidate AstraZeneca is still underway and should ultimately give the FDA a better picture of how well it works. The FDA states that the COVID-19 vaccine needs to be at least 50% effective.

Meanwhile, the UK Government needs to determine if UK data is sufficient for early deployment in the UK.

Still in the pipeline

Johnson & Johnson is also conducting final-stage testing in the United States and several other countries to see if vaccine candidates work with a single dose.

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

Different technologies affect how easy it is to distribute different vaccines around the world. Shots of AstraZeneca do not need to be stored in the freezer like Pfizer and Moderna vaccines.

Candidates made with other technologies are also being tested in the later stages. Another US company, Novavax Inc. Announced on Monday that it has completed enrollment of 15,000 people in the final stage study in the UK and will begin recruiting more volunteers for final exams in the United States and Mexico “in the coming weeks”.

Vaccines made by three Chinese companies and Russian candidates have also been tested by thousands of people in countries around the world.

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The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.

Copyright 2020 AP communication. all rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.

Moderna urges U.S. and European regulators to approve virus attacks

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