The U.S. FDA advisory panel sets a standard for Moderna vaccine approval

(Reuters) – The U.S. Food and Drug Administration (FDA) will work “swiftly” toward the emergency approval of Moderna Inc ‘s COVID-19 vaccine candidate, FDA Commissioner Stephen Hahn said Thursday.

A panel of outside advisers to the FDA strongly supported the emergency use of the Moderna coronavirus vaccine on Thursday, almost confirming a second option for protection against COVID-19 for a country plagued by a pandemic.

The committee voted 20-0 by one voter that the benefits of the vaccine outweighed the risks in people aged 18 and over.

A week ago, the same panel backed a vaccine from Pfizer Inc and German partner BioNTech SE, leading to an FDA (EUA) emergency use approval a day later.

Following Hahn’s comments, the Financial Times reported that the FDA had decided to approve Moderna’s vaccine candidate on an emergency basis. He named people who were close to the process and said the emergency permit would be issued in the coming days.

The FDA and Moderna did not immediately respond to requests for comment on the Financial Times report.

The FDA is expected to approve the EUA late Thursday or Friday.

It would give more hope to a country that lost more than 300,000 lives to COVID-19 – including a one-day rate of 3,580 deaths Wednesday – while the highest number of patients threatened to recover US hospitals and health care workers.

“Going from getting a (genetic) set of virus in January to getting two vaccines in December is a remarkable achievement,” said Dr James Hildreth, chief executive of Meharry College, who voted. to recommend the vaccine for emergency use.

The same refrain came from Dr. Michael Kurilla, who works at the National Institutes of Health and felt that blanket approval for those aged 18 and over was too broad.

“I’m not sure the benefits for these age groups outweigh the risks. And I would prefer it to be more targeted at people who are at high risk from a dangerous and life-threatening COVID infection, ”he said.

Health and Human Services Secretary Alex Azar told CNBC on Thursday that 5.9 million doses of the Moderna vaccine have been dispensed for states and cities and were ready for rollout nationwide.

Vaccines are not a panacea, however, as they take months to be introduced into a country where the virus suddenly runs and there are public health measures such as social distance and wearing a mask. rejected by large sections of the population.

PHOTO FILE: A small shopping basket filled with filters named “COVID-19 – Coronavirus Vaccine” and a medical sryinge are placed on the Moderna logo in this photo taken November 29, 2020. REUTERS / Dado Ruvic / Ilustration


The Moderna vaccine does not require special ultra-cold freezers or large quantities of dry ice, unlike the Pfizer vaccine which needs to be refrigerated and stored at -70 Celsius (-94 F). make it easier to provide rural and remote areas.

Moderna said Thursday it had extended the vaccine’s handling instruction to allow it to move locally in a melting state at normal cooling temperatures. In some cases, Moderna said, this may be the only practical way to move it to clinics or remote locations.

U.S. officials have said they expect to have 40 million doses of the Pfizer / BioNTech and Moderna vaccines by the end of the year – enough to protect 20 million people. Both vaccines were approximately 95% effective in preventing illness in significant clinical trials with no serious safety issues.

The first wave of doses is expected to be identified for health care workers treating COVID-19 patients and vulnerable residents and nursing home staff. The Moderna vaccine, based on new synthetic messenger RNA (mRNA) technology, is administered in two strokes approximately 28 days apart. The Pfizer / BioNTech image is also an mRNA vaccine.

Documents prepared by FDA scientists and released prior to the meeting stated that a two-dose schedule of the Moderna vaccine was highly effective in preventing COVID-19 and did not raise specific safety issues. any.

There were no cases of COVID-19 malignancy among those vaccinated in the trial versus 30 such cases in the placebo group, which may be significant given the importance of hospital intensive care units. filled with infected patients.

The United States in August entered into a $ 1.5 billion deal with Moderna to receive 100 million doses of the vaccine.

Around 20 million doses are expected to be delivered this month, with the rest of the first purchase coming in the first quarter of next year. Last week, Moderna agreed to deliver an additional 100 million doses in the second quarter.

In the global race to deliver highly effective vaccines against the coronavirus, the Massachusetts-based biotech company is reaching the finish line ahead of some much bigger competitors such as AstraZeneca Plc and Johnson & Johnson.

An emergency meeting of the Advisory panel of the U.S. Centers for Disease Control and Prevention is expected to follow the FDA’s approval for the Moderna vaccine with its official recommendation for use by the U.S. public.

After that, state and local public health authorities will begin administering the first dose.

Reporting with Manas Mishra and Manojna Maddipatla in Bengaluru and Michael Erman in New Jersey; Additional commentary by Shubham Kalia; Edited by Caroline Humer and Bill Berkrot