Moderna’s Covid-19 vaccine approved for emergency use in US, 5.9 million doses to be shipped to states
The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Moderna’s coronavirus vaccine on December 18. The vaccine can be given to Americans aged 18 years and older. This is the second vaccine that has been given the green light in the country’s fight against the Covid-19 pandemic after the agency okayed Pfizer-BioNTech’s coronavirus vaccine on December 11. The first shots of the Pfizer vaccine were given to Americans on December 14. Inoculations with Moderna’s vaccine could begin on Monday, December 21.
The FDA determined that the Moderna vaccine has met the statutory criteria for issuance of EUA. The totality of the available data “provides clear evidence” that the Moderna coronavirus vaccine may be effective in preventing the illness, noted the agency. The data also show that the known and potential benefits outweigh the known and potential risks — supporting the company’s request for the vaccine’s use in people 18 years of age and older. The FDA assured the public and the medical community that in making this decision, it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information.
“With the availability of two vaccines now for the prevention of Covid-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the US each day,” said FDA Commissioner Dr Stephen M Hahn in a statement. He added, “Through the FDA’s open and transparent scientific review process, two Covid-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA.”
Stéphane Bancel, chief executive officer of Moderna, said in a statement: “I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna Covid-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants.”
On November 30, Moderna submitted an emergency use authorization (EUA) request to the FDA for its vaccine candidate based on phase 3 results which showed that vaccine efficacy against Covid-19 was 94.1%. An independent analysis by the FDA concurred with the findings.
On December 17, an advisory panel of the FDA recommended the emergency use of Moderna’s Covid-19 vaccine. The question that members had to vote for or against was, “Based on the totality of scientific evidence available, do the benefits of the Moderna Covid-19 vaccine outweigh its risks for use in individuals 18 years of age and older?” The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 20-0 with one abstention to endorse Moderna’s coronavirus vaccine. Following the meeting, the FDA informed the same day that it will “rapidly work” toward finalization and issuance of an emergency use authorization. The agency also notified the US Centers for Disease Control and Prevention (CDC) and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.
How many doses has been secured by the US?
US officials from Operation Warp Speed (OWS) plan to ship just under 6 million doses of Moderna’s Covid-19 vaccine. “If Moderna's vaccine is authorized by the FDA in the coming days, OWS will have allocated nearly 5.9-million doses of the vaccine,” Health and Human Service Secretary Alex M Azar had earlier said during a briefing. He added, “We have a great deal of work in the coming months to get a vaccine to every American who wants one. But we’re confident in our approach to using the healthcare providers and institutions like hospitals and pharmacies that do such a good job of providing tens of millions of vaccines to Americans every year.”
This is more than double the US’s initial shipment of 2.9 million doses of Pfizer’s vaccine. “The difference in quantities is about what was available when we were doing planning to ensure initial delivery. As early as 15th (of) November, I snapped the chalk line on what was available for Pfizer so that states could do planning to the number...We wanted them to have as much time to do the planning and realize where they wanted it to go first,” explained Army General Gustave F Perna, OWS chief operating officer. He elaborated, “I didn’t have to snap the chalk line for Moderna until a week or 10 days later, as we saw where they were in the process. So, they naturally accumulated more vaccines available for the time of final distribution, which allowed me to almost double the availability of Moderna over Pfizer.”
Moderna’s vaccine consists of two doses, four weeks apart. The government will keep further doses as a reserve, as it did with Pfizer’s vaccine. Moderna’s initial doses are to be shipped and distributed to 3,285 locations across the US, again significantly more than for the Pfizer-BioNTech shot.
According to Moderna, on December 11, the US government exercised its option to purchase an additional 100 million doses of mRNA-1273, bringing its confirmed order commitment to 200 million doses. “Securing another 100 million doses from Moderna by June 2021 further expands our supply of doses across the Operation Warp Speed portfolio of vaccines. This new federal purchase can give Americans even greater confidence we will have enough supply to vaccinate all Americans who want it by the second quarter of 2021,” emphasized Azar.
Of the first 100 million doses purchased by the US government, approximately 20 million doses will be delivered by the end of December 2020 and the balance will be delivered in the first quarter of 2021, the company informed. “The new order of 100 million doses will be delivered in the second quarter of 2021,” it added.
"Between the two vaccines, there will be enough doses to immunize 20 million Americans in December 2020, give them a second dose in the month of January 2021 and immunize an additional 30 million then," said Dr Moncef Slaoui, who is leading Operation Warp Speed.
Azar estimated that by the end of February, “We could have a 100 million vaccine shots in arms — between the first dose and booster shots.” The US plans to have 200 million vaccines by the end of the first quarter (by March 2021-end), which will be enough to immunize 100 million Americans, he noted.