Saturday, January 16

Moderna asks European and US regulators to approve its virus injections


Moderna Inc. said it would ask US and European regulators on Monday to allow emergency use of its COVID-19 the vaccine, as the results of a new study confirm that vaccines offer strong protection, increasing the race to start limited vaccines as the coronavirus rampage worsens.
Multiple candidate vaccines It must be successful for the world to end the pandemic, which has been on the rise in the United States and Europe. US hospitals have been stretched to the limit, as the nation has seen more than 160,000 new cases a day and more than 1,400 deaths daily. Since it first appeared nearly a year ago in China, the virus has killed more than 1.4 million people worldwide.

Moderna is right behind Pfizer and its German partner BioNTech in the quest to start vaccines in the US in December. Across the Atlantic, British regulators are also evaluating the injection from Pfizer and another from AstraZeneca.

Moderna created her vaccines with the US National Institutes of Health and already had a clue that they were working, but said she got the final necessary results over the weekend that suggest the vaccine is more than 94 percent effective. .

Modern vaccine
In this July 27, 2020 file photo, Nurse Kathe Olmstead prepares an injection that is part of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc. Moderna said on November 16, 2020, His COVID-19 shot provides strong protection against the coronavirus emerging around the world. (AP)

Of 196 COVID-19 cases so far in their huge US study, 185 were trial participants who received the placebo and 11 who received the actual vaccine. The only people who became seriously ill, 30 participants, including one who died, had received sham injections, said Dr. Tal Zaks, the company’s chief medical officer in Cambridge, Massachusetts.

When he learned of the results, “I allowed myself to cry for the first time,” Zaks told The Associated Press. “Already, only in the trial, we have already saved lives. Imagine the impact that then multiplies in the people who can receive this vaccine.”

Moderna said the vaccines’ effectiveness and a good safety record so far – with only temporary flu-like side effects – means they meet the requirements set out by the U.S. Food and Drug Administration. before the final stage test is completed. The European Medicines Agency, the European version of the FDA, has noted that it is also open to faster emergency authorization.

The FDA has committed that before deciding to implement any COVID-19 vaccine, its scientific advisers will publicly debate whether there is sufficient evidence behind each candidate.

First, on December 10, Pfizer and BioNTech will present data suggesting that their vaccine candidate is 95 percent effective. Moderna said her turn is expected in this “court of science” exactly one week later, on December 17.

If the FDA allows emergency use, Moderna hopes to have 20 million doses ready for the US by the end of the year. Recipients will need two doses, making it 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 destined for the United States.

This week, a different panel of American experts, established by the Centers for Disease Control and Prevention, will meet to decide how the initial supplies will be distributed. They are expected to reserve the meager first doses for healthcare workers and, if the vaccines work well enough in the frail elderly, for residents of long-term care facilities. As more vaccines become gradually available in the coming months, other essential workers and people at higher risk of contracting the coronavirus will line up. But not enough is expected for the general population until at least the spring.

Moderna Inc.
In this May 18, 2020 file photo, a sign marks the entrance to a Moderna, Inc. building in Cambridge, Massachusetts. (AP)

Outside of the US, Zaks said that Moderna’s important supplies will be available later “in the first quarter” of next year.

“Obviously, we are doing everything in our power to increase capacity and speed up deadlines,” he said.

Both Moderna and Pfizer’s vaccines are made using the same technology, using a piece of genetic code for the “spike” protein that embeds the virus. That messenger RNA, or mRNA, signals the body to produce a harmless spike protein, training immune cells to recognize it if the real virus does eventually appear.

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

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

Experts say it’s not clear why the lower dose approach would work better and that it may just be a statistical quirk.

A larger study is still underway in the US of the AstraZeneca candidate that should eventually give the FDA a better idea of ​​how well it works. The FDA has said that any COVID-19 vaccine should be at least 50 percent effective.

In the meantime, the British government will have to decide whether its UK data is sufficient for early deployment there.

Johnson & Johnson is also in the final stages of testing in the US and several other countries to see if its vaccine candidate could work with a single 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.

Different technologies have ramifications for the ease with which different vaccines can be distributed globally. AstraZeneca injections will not require freezer storage like Pfizer and Moderna vaccines.

Candidates made with other technologies are also in the final stages of testing. Another US company, Novavax Inc., announced on Monday that it finished enrolling 15,000 people in an advanced-stage study in Britain and plans to start recruiting even more volunteers for final tests in the United States and Mexico “in the next few weeks.” .

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

– Reported with Associated Press


www.9news.com.au

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