December 18, 2020 – As expected, the FDA granted Moderna emergency use approval for its COVID-19 vaccine, doubling the number of vaccine doses expected to be marketed nationwide in the coming days.
There’s a final step: the CDC’s Advisory Committee on Immunization Practices must recommend its use, as it did two days after receiving the EEA of the Pfizer vaccine on December 10th.
The EEA for the Moderna vaccine is “an important milestone in trying to contain this pandemic,” said Dr. Hana Mohammed El Sahly told Medscape Medical News.
Next, the distribution of the two vaccine products will be expanded.
“Even in less emergent conditions, it can sometimes be difficult to make sure that people who need a vaccine are difficult. I hope media attention makes more people aware that there are vaccines that could help them.”
said El Sahly, chairman of the FDA’s Advisory Committee on Vaccines and Related Biological Products (VRBPAC).
The emergency approval for the Moderna vaccine follows a review by the independent committee on Thursday, which voted 20-1, with one abstention, to recommend approval.
The emergency approval of a second COVID-19 vaccine “is great – we need all the tools to fight this pandemic. Moderna’s early data looks good and I agree with the FDA that an EEA is warranted,” said Stephen Schrantz . MD, an infectious disease specialist and assistant professor of medicine at UChicago Medicine, told Medscape.
“It is up to all of our health professionals to support this vaccine and help people get it,” said Schrantz. “We want to make sure people on the fence understand that this is a safe vaccine that has been adequately reviewed by the FDA and Phase III clinical trials.
“I know the critical role doctors play as vaccine influencers,” said Dr. Susan Bailey, president of the American Medical Association, during a webinar for journalists on December 14th. “We must keep doing what doctors have always done. Check the evidence and trust science. Lives are at stake.”
Ramp up vaccinations for healthcare providers
“I’m excited to see the FDA’s positive evaluation of the Moderna vaccine. We have been waiting for another vaccine to use on health care workers – and now we have it,” said Aneesh Mehta, MD of the Emory University School of Medicine in Atlanta, Medscape said.
“We were hoping to see a vaccine that was 70% or 80% effective and it is remarkable to see two vaccines now that are greater than 90% effective,” he added.
The efficacy levels associated with both the Pfizer and Moderna Messenger RNA vaccines “have certainly exceeded expectations – that’s why we didn’t set up the studies. It was surprising in the good sense of the word,” said El Sahly, who is also an Associate Professor of Molecular Virology and Microbiology and Researcher in the Vaccine and Treatment Evaluation Department at Baylor College of Medicine in Houston.
Unanswered questions remain open
Schrantz also said the high rate of effectiveness is positive. “Apart from that, we know about this vaccine that it is very effective at preventing disease. We currently have no understanding of whether or not these vaccines prevent infection and communicability.”
Bailey said, “The jury is not yet sure whether or not you can still transmit the virus after the vaccine. Hopefully not, but we don’t know for sure.”
“It’s risky to think that once you get the shot in your arm everything will be back to normal. It doesn’t,” added Bailey.
Another unknown is the duration of protection after immunization. Pfizer and Moderna’s products “share similar constructs, appear to have an adequate safety profile and excellent short-term efficacy,” said El Sahly. However, she warned that long-term effectiveness has yet to be determined.
Whether rare adverse events occur is another question. The answers could come from ongoing Phase III trials over time, as well as from monitoring vaccine recipients.
“Our work doesn’t get done after an EEA is issued,” said FDA Commissioner Stephen Hahn in a JAMA webinar on December 14th. The FDA closely monitors whether adverse events are above normal background incidence. “We will be transparent about it when we see something that is not at the base level.”
Benefits beyond the numbers?
“The main benefit of having two vaccines is pure volume,” said Mehta. An added benefit of having more products is the potential to offer an option if a particular vaccine is not recommended for certain people. “We could offer someone a different vaccine … similar to what we do with the influenza vaccine.”
“The more the better, the more vaccines there are,” said Schrantz. Despite differences in shipping, storage, minimum age, and dosage intervals, Pfizer and Moderna vaccines are very similar, he said. “Really the only difference between these two vaccines is the proprietary lipid nanoparticle – the vehicle, if you will.”
Both vaccines “appear to be very similar in their ability to protect against disease [people in] Paul Offit, MD, director of the Vaccine Education Center at Philadelphia Children’s Hospital and a member of the FDA advisory committee, said he comes from a variety of racial and ethnic backgrounds and is able to protect himself from serious illness.
Regarding vaccines in the development pipeline, “We don’t know, but we may see a difference from the Johnson & Johnson vaccine or the Janssen vaccine which are single-dose. They may offer some benefits, but we are waiting then the safety and effectiveness data, “said Schrantz.
As a two-dose vaccine, the AstraZeneca product dose offers no dosing strategy benefit, “but it is easier to transport than the mRNA vaccines,” he said. Some concerns about the initial data on the AstraZeneca vaccine likely need to be addressed before the company applies for EUAs, Schrantz added.
“That is an important question,” said El Sahly. The ongoing studies should provide more data from participants of all ages and races that will allow us to “determine if there is a difference between these two vaccines.”
She added that Pfizer and Moderna vaccines appear to be comparable from the early data. “We’ll see if this stands in the long run.”
Future perspective
After the FDA approves the emergency use of two COVID-19 vaccines, “every state must quickly implement its plans to put the vaccines in the hands of vendors who must dispose of the vaccines,” Mehta said. “We are seeing a very effective rollout in several regions of the country. We hope this will continue as we receive more vaccines from manufacturers in the coming months.”
“Within a year of identifying the sequence of this virus, we have two large clinical vaccine studies that are showing effectiveness,” Offit said. “That was an amazing technological feat, but now comes the hard part. It is going to be really, really hard to mass-produce this vaccine, get it published and make sure that whoever gets the most benefit from it gets it.”
“But I’m optimistic,” said Offit. “If we can do this by the next Thanksgiving Day, we’ll see a dramatic decrease in the number of cases, hospitalizations and deaths, and we will be able to get our lives back on track.”
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