Modern seeks approval from US, European regulators for emergency use of its Covid vaccine

Moderna Inc. said it would ask U.S. and European regulators on Monday to allow emergency use of its COVID-19 vaccine as new study results confirm that the shots provide strong protection – speeding up the race to begin limited vaccinations as the coronavirus ramp worsens.

Several vaccine candidates must succeed in order for the world to eradicate the pandemic, which has been on the rise in the United States and Europe. US hospitals have reached their limit as the nation has seen more than 160,000 new cases per day and more than 1,400 daily deaths. Since the virus appeared almost a year ago in China, more than 1.4 million people worldwide have been killed.

Moderna is just behind Pfizer and its German partner BioNTech to begin vaccinations in the United States in December. British regulators are also evaluating the Pfizer shot and another from AstraZeneca.

Modern created its images with the US National Institutes of Health and already had a hint that they were working, but said they got the final results needed over the weekend indicating that the vaccine is more than 94% effective.

Of the 196 cases of COVID-19 so far in its huge US study, 185 subjects received placebo and 11 received the correct vaccine. The only people who became seriously ill – 30 participants, including one who died – had received dummy shots, said Dr. Tal Zaks, Cambridge, Massachusetts, the company’s medical director.

When he found out the results, “I allowed myself to cry for the first time,” Zaks told the Associated Press. “We have already, just at the trial, already saved lives. Imagine the effect that is then multiplied by the people who can get this vaccine. ”

Modern said the effectiveness of the shots and a good safety record so far – with only temporary flu-like side effects – means that they meet the requirements set by the US Food and Drug Administration for emergency use before the final test is complete. The European Medicines Agency, Europe’s version of the FDA, has announced that it is also open to faster “conditional” approval.

What comes next

The FDA has promised that before deciding to roll out any COVID-19 vaccines, its scientific advisers will publicly discuss whether there is enough evidence behind each candidate.

Only on December 10 will Pfizer and BioNTech present data indicating that their vaccine candidate is 95% effective. Moderna said that his turn at this “science court” is expected exactly one week later, on December 17.

If the FDA allows emergency use, Moderna expects to have 20 million doses ready for the United States by the end of the year. The recipients need two doses, so that is 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 United States

Shipments are scheduled to begin in the states within 24 hours of FDA approval. And this week, another panel of US experts, set up by the Centers for Disease Control and Prevention, will meet to decide how the first deliveries will be distributed. They are expected to reserve scarce first doses for healthcare professionals and, if the shots work well enough in frail elderly, for residents of long-term care facilities.

As more vaccines gradually become available in the coming months, other important workers and people at highest risk from coronavirus would line up. But enough for the general American population is not expected until spring.

Outside the United States, Zaks said significant deliveries from Moderna would be available later, “during the first quarter” next year.

“Obviously we are doing everything we can to increase capacity and speed up timelines,” he said.

The British government said on Sunday that it had ordered 7 million doses from Moderna.

The United Kingdom has also ordered 40 million doses of the Pfizer-BioNTech vaccine, although it is not clear how much of the companies’ limited December supply could go against that scheme – if UK health authorities remove the shots. Still, British hospitals are ready to receive a few doses as early as next week.

Both Moderna’s and Pfizer’s vaccines are made using the same technology, with a piece of genetic code for the “nail” protein that bounces off the virus. The messenger RNA, or mRNA, instructs the body to make some harmless nail protein, training immune cells to recognize it if the real virus eventually comes.

AstraZeneca confusion

AstraZeneca and Oxford University last week announced confusing early results from their vaccine candidate from research in the UK and Brazil.

That vaccine is 62% effective when tested as originally intended, and the recipients received two full doses. However, due to a manufacturing defect, a small number of volunteers received a lower first dose – and AstraZeneca said in that group the vaccine seemed to be 90% effective.

Experts say it is unclear why the lower dose method would work better and that it can only be of a statistical nature.

A major US study of the AstraZeneca candidate is still ongoing, which should eventually give the FDA a better idea of ​​how well it works. The FDA has stated that all COVID-19 vaccines must be at least 50% effective.

In the meantime, the UK government will need to decide whether its UK data is sufficient for an early launch there.

Still in progress

Johnson & Johnson is also in final stage testing in the United States and several other countries to see if its vaccine candidate can work with just one dose.

Both the J&J and AstraZeneca vaccines work by using harmless cold viruses to carry the nail protein gene into the body and prime the immune system.

The different technologies have consequences for how easily different vaccines can be distributed globally. AstraZeneca shots do not require freezer storage like the Pfizer and Moderna vaccines.

Candidates made with even different technology also participate in late tests. Another US company, Novavax Inc., announced on Monday that it is ready to register 15,000 people in a recent study in the UK and plans to recruit even more volunteers for final exams in the US and Mexico “in the coming weeks.”

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