With promising results from Pfizer and Moderna’s Covid-19 Phase 3 trials, the FDA has pledged to act “as soon as possible” to clear both vaccines for emergency use, according to reports from CNBC.
On Monday, Alex Azar, secretary of the US Department of Health and Human Services, told the cable business network that the FDA is hiring teams to work with each company to “remove unnecessary bureaucratic barriers to completing permit applications.”
“We hope that these Pfizer and Moderna applications will be received as soon as possible,” Azar told CNBC. “We’re going to relate these balls and strikes to the data and evidence independently, but we’re going to do this as soon as possible to make sure that only the science, evidence, and law support approval.”
Vaccines can be very effective
Moderna announced on Monday that its vaccine, according to Phase 3 test results, reduced the risk of Covid-19 infection by 94.5%. That news came a week after Pfizer, working with BioNTech, announced that the Covid-19 vaccine was more than 90% effective. Health experts had hoped for a vaccine that was at least 50% effective. In the past few years, the flu vaccine has been between 20% and 60% effective.
Anthony Fauci, MD, director of the National Institute for Allergies and Infectious Diseases (NIAID), said the preliminary data from both vaccine trials are better than expected. Dr. Fauci said he would have been happy with a vaccine that was 70% to 75% effective, according to STAT, an online health news website.
“I would like to say that I would have predicted it, but I wouldn’t have,” said Dr. Fauci to STAT. “To be honest, I didn’t expect that. I thought it was too much to hope for. ”
Dr. Fauci said six vaccine candidates are in various stages of their clinical trials and testing. Moderna and Pfizer, as well as other pharmaceutical companies like Johnson & Johnson, AstraZeneca, and GSK, have vaccines in phase 3 studies. Moderna and Pfizer are fully enrolled and collect data on effectiveness and safety.
While the results have raised hopes that a vaccine will eventually end the pandemic, rates of effectiveness are likely to change as the studies progress. The early numbers were very limited: fewer than 100 participants in each company’s Phase 3 study developed Covid-19, according to the Associated Press. These experiments were carried out on many people around the world. The Moderna trial was carried out at 100 trial locations. with more than 30,000 participants. It started at the end of July.
Another problem is how long the vaccination protection lasts.
Still, the early results are a good indication that a vaccine will prevent the disease in many people once large groups of people are vaccinated.
The road to approval
Moderna has enrolled its participants to test the vaccine candidate mRNA-1273, which was developed in partnership with NIAID.
More than 25,650 participants received their second vaccination against mRNA-1273 at a dose of 100 micrograms on October 22nd. Once the researchers complete two months of safety monitoring, they will determine if the benefits outweigh the risks and apply for an emergency application for FDA approval.
The Phase 3 Moderna study was designed to evaluate those at highest risk for the coronavirus. Over 7,000 of the participants are over 65 years old and more than 5,000 under 65 years of age suffer from chronic high-risk diseases such as diabetes and heart disease. Under-represented communities were also involved in this clinical research, with 37% of participants coming from color communities.
Additional data are still being collected in studies at Pfizer and BioNTech, but no serious safety concerns have been reported. They estimate they will produce up to 50 million vaccine doses worldwide by 2020 and up to 1.3 billion doses by 2021. Its Phase 3 clinical trial began in July and has 43,538 participants. Of these, 38,955 people had received the second dose of the vaccine on November 8th.
Between Moderna and Pfizer, about 40 million doses of coronavirus vaccines should be made by Jan. 1, enough to vaccinate about 20 million people. Both vaccines must be given twice, said Secretary Azar, who oversees Operation Warp Speed.
Take them home
According to the World Health Organization (WHO), there are more than 100 Covid-19 vaccine candidates in development and many in human studies. COVAX is an alliance created by WHO to facilitate access and distribution of the vaccine when it is determined to be safe and effective.
As more research comes out, healthcare workers are learning how to treat their patients more effectively. For example, doctors now know how much oxygen to provide when patients are intubated and when patients need to be ventilated.
“We know that dexamethasone significantly lowers the death rate in people who require mechanical ventilation and / or in people who require high flow oxygen,” said Dr. Fauci.
Sammy Lucero is a co-op nursing student at Drexel University.
Robert Calandra is an award-winning journalist, author, and playwright. His work has been published in national and regional magazines and newspapers.