FDA Reviewing Moderna’s COVID-19 Vaccine

FDA announced that the Vaccines and Related Biological Products Advisory Committee will meet on December 17, 2020, to discuss Moderna Inc’s request for EUA of is COVID-19 vaccine – for the prevention of COVID-19 in individuals 18 years-of-age and older. Meeting participants will be joining the meeting remotely via an online teleconferencing platform.

The FDA agenda for the meeting

Presentations will be listened to, viewed, captioned, and recorded. The Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in an open session. The purpose of the meeting is to discuss granting an Emergency Use Authorization (EUA) for the Moderna, Inc., COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years and older.

Materials for the meeting

FDA will make background material available to the public no later than two days before the meeting. FDA hopes to post the background material on its website before the meeting. Any material that can’t be posted will be made available to the public when the meeting is held -and will be posted on FDA’s website after the meeting.

The meeting will include slide presentations and audio so the presentation closely resembles an in-person advisory committee meeting.

Members of the public who are interested may offer data, information, or views, orally or in writing, on issues pending before the committee. There is a docket (FDA-2020-N-2242) for the meeting which will close the day before the meeting. The docket is so that public comments can be considered.

The http://www.regulations.gov/https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 16, 2020. Comments can also be sent may mail/hand deliver/courier (for written comments) if they are postmarked or the delivery service acceptance receipt is on or before that date.

The committee should be able to review comments received prior to December 11, 2020. Comments received between December 11 and December 16 should be taken into consideration by FDA. If the meeting is canceled for some reason, FDA “will continue to evaluate any relevant applications, submissions, or information, and consider any comments submitted to the docket, as appropriate.”

The FDA announcement continues by indicating how electronic submissions can be made. The agency suggests making handwritten submissions if anyone wants to submit a comment that has confidential information that should not be disclosed to the public. There are further instructions for written/paper submissions and for making oral presentations at the meeting.

The meeting should be available online.

Availability of the Moderna vaccine

According to a report from CNBC, U.S. officials said that once FDA issues an EUA, there are plans to ship about six million doses of their COVID-19 vaccine. According to Gen. Gustave Perna, who is currently overseeing the Trump administration’s Operation Warp Seed, the doses from Moderna will be sent to the medical supply company McKesson for packing and distribution. UPS and FedEx will then send the shipments to their final destinations. The six million doses are in addition to the 2.9 million doses the US government acquired from Pfizer’s vaccine which was approved for an Emergency Use Authorization.

The Moderna COVID-19 vaccine requires two doses four weeks apart. Approximately 100 million vaccine doses of the vaccine were secured by the US government. The doses should be available during the second quarter of 2021.

General Perna told reporters, “The difference in quantities was about what was available when we were doing planning for initial delivery.” “As early as 15th [of] November, I snapped the chalk line on what was available to Pfizer so states could do the planning. … We wanted them to have enough time as possible to do the planning and realize where they wanted to go first.”

The first doses of the Pfizer vaccine have already been given to some people, starting with health care workers at New York’s Northwell Health. A critical care nurse, Sandra Lindsay, who works at Long Island Jewish Medical Center was given the first shot – to the cheers of onlookers.

General Perna added that many states are coordinating the vaccine distribution efforts with Walgreens, CVS Health, and other local pharmacies to help ensure rural areas and other locations get their fair share of the vaccines. Each state is getting a share and then the state decides where each dose goes.

Officials expect that it will take months before everyone in America who wants a vaccine is able to get a vaccine. The states are evaluating the priorities for who gets the vaccines. As a general rule, expectations are that the most critical workers, starting with health care workers, and the most vulnerable people, starting with nursing home residents, will get the vaccine first. Each state has discretion as to how the vaccines can be distributed.

FDA’s Vaccines and Related Biological Products Advisory Committee could approve the EUA, just as the committee did for the Pfizer vaccine, as early as Thursday, December 17, 2020. FDA, as the agency did with the Pfizer vaccine. FDA could then approve the EUA for the Moderna vaccine, the next day – Friday, December 18, 2020.

Dr. Moncef Slaoui, who is leading Operation Warp Speed, said that “U.S. officials expect 20 million Americans to get their first shot of Moderna’s or Pfizer’s vaccine” in December 2020. By the end of February 2021, the expectations are that about 100 million people will be given the vaccines.

Just like the US government is doing with the Pfizer vaccine, the government is setting aside additional doses of the Moderna vaccine so patients can get their second doses as well. General Perna “didn’t disclose how much of Moderna’s vaccine would be put in the reserve, but the U.S. set aside 500,000 doses from Pfizer.” US Health and Human Services Secretary Alex Azar confirmed that the government is setting aside enough doses for the second shots of the Pfizer vaccine – and is expected to set aside enough second shots of the Moderna vaccine.

Dr. Slaoui informed reporters last week that “the government might be willing to push more COVID-19 vaccine to the public without holding second doses ‘by the middle of the month of January or early February when we’ve had five, six weeks of rolling, high-cadence manufacturing, and that we see that things are rolling perfectly.’”

“This is about making sure we’re prepared to mitigate situations,” Perna said Wednesday. “As our process matures, both in manufacturing and in distribution, as I said before, the safety stock will go down significantly. Our goal, the guidance I’ve been giving, is vaccine sitting on a shelf is not effective. We have two vaccines that are highly effective, and we want to get it to the American people.”

The Moderna clinical trials

The Washington Post reported on December 15, 2020, that the panel of independent experts that authorized the Pfizer-BioNTech vaccine, by a vote of 17 to 4 that will be considering data from Moderna that is similar to the data from Pfizer. The Moderna COVID-19 vaccine, which is given in two shots, had been found to be very effective against the disease. In the trial, none of the 30 cases of severe COVID-19 were in the group that got the vaccine. “The Moderna vaccine worked well, regardless of age, race, and gender. The adverse events associated were widespread, but short-lived, including fatigue, muscle aches and pain at the injection site.”

In the clinical trial run by Moderna, 30,000 people were randomly given either two dosages of the vaccine or two saline shots – at random. None of the participants, nor the people who ran the trial, knew which person got the vaccine and which person got the placebo. “Investigators then waited as people were exposed to coronavirus in their daily lives, to see if there were more covid-19 infections in the group that did not receive the real vaccine.”

The numbers provided strong evidence that the Moderna vaccine worked well. Of the 196 people who developed COVID-19, 185 were in the placebo group. As mentioned, there were 30 cases of people who developed severe COVID-19 (including one death) and all of those 30 were people who were given the placebo.

The clinical trial was slowed down during the summer “because scientists were concerned it lacked sufficient racial diversity to determine whether it truly protected those at highest risk of the disease.”

“In the end, a fifth of participants were Hispanic, 10 percent were Black and four percent were Asian. More than 40 percent of the participants were either over the age of 65 or had medical conditions that increased their risk of severe disease.”

According to Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center who co-leads the government’s clinical trial network responsible for testing coronavirus vaccines, “The trial enrolled the right people at risk. For us who were designing the trial and enrolling the people, that’s so fantastic.”

Manufacturers of medical products such as vaccines and medical devices that promote treatments, diagnostic abilities, or cures that don’t have FDA approval or an FDA EUA are subject to warning letters and other FDA legal actions.

The Washington Post added that Moderna developed its vaccine working with the National Institute of Allergy and Infectious Diseases – “and with the government underwriting the research and development of the vaccine and the advanced purchase of 200 million doses, bringing the taxpayer investment to $4.1 billion.”

Other possible vaccines

The New York Times reports that several other possible vaccines the US hoped would add to its vaccine supply still need work before FDA can consider them.

• One vaccine is from the pharmaceutical companies Sanofi of France and GlaxoSmithKline of Britain. This vaccine had disappointing results in early clinical trials, especially for older adults. The company is now planning new trials for a different version of the vaccine.
• The other is from the British-Swedish drug maker AstraZeneca and the University of Oxford. This vaccine, which uses two doses, had confusing results. “At one level, the efficacy was 62 percent, and at the other it was 90 percent. These muddled results have left it unclear when AstraZeneca will have enough data to secure an emergency use authorization.

FDA emergency use authorization is expected for Moderna’s COVID-19 vaccine on or about December 18, 2020. Once the EUA is granted, there will be two mRNA vaccines that will be used immediately to help contain the deadly virus which has caused a worldwide pandemic and suffering across the globe. The federal government is working with Moderna and Pfizer (and will work with any other companies that are granted EUAs for their vaccines) to arrange to have the vaccines distributed throughout the country.

Each state is creating its own distribution plan. These plans include deciding the priority of people who will receive the vaccine. Healthcare workers and nursing home residents are at the top of most, if not all, priority lists. Essential workers, people with risk factors, and the elderly are expected to get vaccines before most Americans receive their vaccines. The Moderna and Pfizer vaccines require that each patient receive two doses of the vaccine.

Medical companies and medical practitioners should contact Cohen Healthcare Law Group, PC for legal advice on any medical product or service. Our experienced healthcare attorneys have represented hundreds of businesses and physicians on their healthcare compliance requirements.