• Fri. Dec 16th, 2022

An FDA advisory panel is expected Thursday to recommend authorization of the COVID-19 vaccine developed by Moderna. It could be in states by Monday.

Dec 17, 2020

The U.S. has now lost over 300,000 people to COVID-19. Here are some other startling statistics from December, 2020.
A second COVID-19 vaccine likely will receive a thumbs up Thursday from an advisory committee to the U.S. Food and Drug Administration, which authorized the first one a week ago.
This time, the committee is reviewing a vaccine made by Cambridge, Massachusetts, biotech Moderna, with similar technology and results as the one it supported last week by Pfizer and its German collaborator, BioNTech. 
A clinical trial in 30,000 volunteers showed that the Moderna vaccine is more than 94% effective in preventing COVID-19, including serious disease. The vaccine causes frequent side effects like sore arms, fatigue, muscle aches and chills, but all were temporary. 
“It’s a very exciting two weeks,” said Barry Bloom, an immunologist at the Harvard T.H. Chan School of Public Health. “To have two companies put forward new vaccines within 11 months and begin to roll them out to the public  that’s an extraordinary both scientific and logistical achievement.”
Your vaccine questions, answered: I had COVID, should I still get vaccinated? What are the side effects? What are its ‘ingredients?’
Both of these first two vaccines showed similar effectiveness and safety, and are based on mRNA technology, which uses the body’s own process of producing proteins to fight off the virus that causes COVID-19.
The FDA’s Vaccines and Related Biological Products Advisory Committee will meet all day Thursday to discuss the details of the Moderna vaccine and is expected to decide that its benefits outweigh its risks.
If this independent group gives its OK, the vaccine will go to the FDA commissioner for his approval, likely Friday. An independent advisory committee to the Centers for Disease Control and Prevention is planning this weekend to consider adding the vaccine to the national adult vaccine schedule, and if they sign off, it will go to the CDC director for his approval. 
Modernas experimental COVID-19 vaccine on Nov. 16, 2020, in Paris.
 (Photo: Joel Saget/AFP via Getty Images)
The Moderna vaccine is expected to arrive in states Monday. 
Moderna has promised to make 50 million doses of its vaccine available this month, enough to vaccinate 25 million people, largely health care workers and nursing home residents. Alex Azar, the secretary of Health and Human Services, said Wednesday that 5.9 million doses of Moderna’s vaccine are likely to be distributed next week, following 2.9 million doses of Pfizer-BioNTech’s this week.
Azar also noted that two recent polls showed American attitudes toward COVID-19 vaccination are becoming more positive, with 70% in one poll and 80% in another saying they plan to get vaccinated.
“We still have much work to do to ensure that all Americans understand the value of these safe, effective vaccines,” Azar said. “But it’s clear that many Americans are learning the vaccines are safe and extraordinarily effective.”
Moderna vaccine trial has limited data for Black, Hispanic people
Moderna data reviewed by the FDA showsits vaccine is equally safe and effective for all subgroups studied, including people who are Black and/or Hispanic, over 65, and for those with health issues such as diabetes.
Several of the VRBPAC members who abstained or voted against the Pfizer-BioNTech vaccine said they voted “no” because they were concerned about allowing its use in 16- and 17-year-olds with only limited safety and effectiveness data in that age group. They said they supported approval in adults.
The Moderna vaccine will be considered only for authorization in adults because it did not add teenagers to its trial until recently, so it has not accumulated enough data. 
One new issue for the Moderna vaccine may be the results among Black and Hispanic participants. 
Moderna realized partway through its trial that its volunteer base did not reflect the country’s diversity, so it slowed sign-ups for a few weeks to add more people of color to the trial. That means there is less than two months’ data for people of color.
There’s skepticism in Black, Latino communities about COVID-19 vaccines. Women of color can help swing the momentum
But the information that has been collected is in line with the Pfizer-BioNTech trial, which was more diverse throughout its recruitment of 44,000 participants, half of whom, as in the Moderna trial, received the active vaccine and half a saltwater placebo.
The Moderna vaccine also appeared to be extremely safe. Although most recipients endured side effects, the vast majority of those lasted just a day or two.
Side effects are a sign that the vaccine is working, not a cause for concern, said Dr. David Weber, an infectious disease specialist at the University of North Carolina.
Weber, who received the Pfizer-BioNTech vaccine Wednesday, said he’s had no side effects so far.
“If I didn’t have a picture proving I had the vaccine, I wouldn’t know it,” he said late Wednesday, adding that he’d much rather suffer a day’s worth of arm pain than catch COVID-19. 
Having two vaccines available will add another layer of complexity to an already complicated vaccine delivery process, but Weber said the system can handle it. 
Pharmacists are trained in how to manage different medications and vaccines and not to mix up different flu vaccines, for instance, he said.
“I don’t think it’s insurmountable,” he said.
People who get the first dose of either the Pfizer-BioNTech or the Moderna vaccine should get the second dose of the same vaccine.
Weber said he received a pocket card telling him which vaccine he received and when to come back for his second shot. 
Because it has less stringent temperature requirements and comes in smaller packaging than Pfizer’s vaccine, Moderna’s will likely be sent to more rural areas and to nursing homes that require a few hundred rather than 1,000 doses.
HHS Secretary Alex Azar: ‘It’s the beginning of the end’ of COVID-19
In a press conference Wednesday, Azar said he has been struck by how ordinary the process has seemed so far, with vaccine deliveries made, doses readied and shots given without any major hitches.
“‘This is what we do.’ That’s been the message from virtually every partner that we are working with in this endeavor,” he said. “We have a great deal of work in the coming months to get a vaccine to every American who wants one. But we are confident in our approach to using the health care providers, institutions like hospitals and pharmacies that do such a good job of providing the vaccines to Americans every year.”
Azar has been intimately involved in the vaccine development process since the beginning, developing the idea for what last spring became Operation Warp Speed.
The effort, co-led by vaccine developer Moncef Slaoui and U.S. Army Gen. Gustav Perna, has shepherded these two vaccines, as well as three more now in human testing. Roughly $10 billion has been spent so far to develop, manufacture and now distribute the vaccines. (Pfizer and BioNTech took money only as a guarantee that the U.S. government would buy 100 million doses of their vaccine, choosing to develop it at their own cost.) 
This German scientist was focused on cancer, then came COVID-19: It was her ‘duty’ to help develop a vaccine.
Azar’s vision was to have companies build out their manufacturing capacity at the same time they were developing their vaccines, so the product would be ready to get out to the public as soon as it received approval  as has happened in the last week.
At the beginning of the effort, Azar told his team: “We have just spent $3 trillion of taxpayer money because of this COVID pandemic. Literally, there is no amount of money that we could credibly spend that would not have an infinite return on investment. So money is no object … We are limited only by the laws of science and physics.”
Azar said his background in both government service and business enabled him to come up with an approach that took advantage of the best of both.
Government, he said, is great at logistics, like delivering the vaccine across the country, and taking risk out of  the process for pharmaceutical companies by prepaying for vaccines. With the 2014-2015 Ebola epidemic, for instance, by the time vaccines were developed, there were no longer any customers for them.
Azar said he learned those lessons when he was undersecretary of HHS in the Bush administration, when the H1N1 flu threatened Americans.
He remembers giving a speech to his boss, telling him that America  the country that had developed the atom bomb to end World War II and delivered a man to the moon in less than a decade had the resources and scientific process to produce a safe effective vaccine.
“And the secretary turned to me, and he said ‘Alex, get it done,'” he recalled.
 Azar did get it done then, and he used the same analogy and playbook this time in throwing the full weight and financial power of the U.S. government behind the task of making a COVID-19 vaccine.
Where’s the COVID-19 vaccine? Who’s been vaccinated? Here’s how we’ll know.
In between his periods of government service, Azar ran the American arm of the drug company Eli Lilly, learning the strengths and limitations of the pharmaceutical industry.
That experience, he said, taught him the challenges of manufacturing vaccines at the tremendous scale needed to bring an end to the COVID-19 pandemic.
“Making vaccines is very complex business,”  he said. “To make these proteins and bioreactors is as much art as science.”
Even now, manufacturing challenges are slowing down efforts to get vaccines out to the public as quickly as possible, Azar said Wednesday.
But the U.S. Army Corps of Engineers and others at Operation Warp Speed are currently working with companies to boost yield and the supply chain, to make vaccine as quickly and safely as possible to meet demand.  
“We’re not the end, but it’s the beginning of the end of this terrible pandemic,” Azar said.
Contact Karen Weintraub at kweintraub@usatoday.com
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
Last SlideNext Slide
Read or Share this story: https://www.usatoday.com/story/news/health/2020/12/17/moderna-covid-19-vaccine-fda-final-review-authorization/6538175002/