UPDATE 11/30/20: On Monday, Moderna became the second drugmaker to request emergency use authorization from the Food and Drug Administration for a COVID-19 vaccine. The news came as the company revealed more positive data about its vaccine, including that it prevented 100 percent of severe COVID-19 outcomes in those who received it. Similar to Pfizer’s, the Moderna vaccine — called mRNA-1273 — uses messenger RNA to identify the virus’ spike protein, and then trigger an immune response.
Pfizer requested emergency use authorization from the U.S. Food and Drug Administration on Friday for its COVID-19 vaccine candidate, getting Americans one step closer to a highly-anticipated weapon in the fight against the coronavirus.
“It is with great pride and joy — and even a little relief — that I can say that our request for emergency use authorization for our COVID-19 vaccine is now in the FDA’s hands,” Pfizer chief executive officer Albert Bourla said in a video shared on Twitter Friday. “This is a historic day, a historic day for science and for all of us. It took just 248 days to get from the day we announced our plans to collaborate with BioNTech to our FDA submission day.”
What does emergency use authorization mean?
Debra Goff, a professor of pharmacy practice at Ohio State University and an infectious diseases specialist at the university’s Wexner Medical Center, tells Yahoo Life that emergency use authorization (EUA) “permits the FDA Commissioner to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a declared health emergency.”
She adds: “During the COVID-19 pandemic, the FDA considers the potential benefit that an EUA would provide” in light of the fact that, currently, there are no other approved vaccines available. (Drugmaker Moderna is expected to request an EUA soon for its own COVID-19 vaccine, which is reporting a 94.5 percent efficacy rate against the virus.)
Going this route is a faster way of getting FDA approval when time is of the essence. “Emergency use authorization does not take the same amount of time as needed for FDA approval,” explains Goff. “In issuing an EUA, the FDA must determine that the product may be effective in treating or preventing a serious disease and that there are no adequate, approved and available alternatives.”
Have there been other cases of emergency use authorization?
This isn’t the first time a drug or medical equipment has been issued an EUA during the coronavirus pandemic. On Nov. 19, the FDA approved one for the prescription drug baricitinib to be used in combination with the drug remdesivir “for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO),” according to the FDA. The drug combination has been shown to shorten recovery time “within 29 days after initiating treatment” compared to patients who received a placebo with remdesivir, according to the agency.
Other EUAs have been issued for certain types of personal protective equipment, or PPEs, such as “face shields, other barriers and respiratory protective devices such as respirators,” according to the FDA.
How does it impact the vaccine timeline?
Now that the EUA request for Pfizer’s COVID-19 vaccine candidate has been filed, the next step is for the FDA’s vaccines advisory committee to meet on Dec. 10 to review the safety data on the drug. That means the EUA approval “could come shortly after that, and the vaccine may be available by the end of the year,” says Goff.
Dr. Dean Winslow, an infectious disease physician at Stanford Health Care, tells Yahoo Life: “The limiting factor will be supplies of the vaccine. It takes a while to spin up production of a biological product like a vaccine.”
However, according to a Pfizer press release announcing the filing, FDA approval would “potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.”
In the video that Pfizer’s CEO shared on Twitter, Bourla said they could begin shipping the vaccine “immediately” after receiving FDA approval. The drugmaker expects to produce up to 50 million doses of the vaccine in 2020, and up to 1.3 billion doses by the end of 2021.
Goff says that Operation Warp Speed — the government’s goal to make and deliver 300 million doses of vaccines, with the initial doses launching by January 2021 — has accelerated the development of a COVID-19 vaccine “in record time.”
What are the logistical hurdles involved in distribution the vaccine?
One challenge, however, is that Pfizer’s vaccine candidate needs to be stored and shipped at very cold temperatures. But according to the Pfizer press release, the drugmaker has “specially designed, temperature-controlled shippers” to distribute the vaccine candidate globally. These containers can maintain the recommended temperature (minus-70 degrees C or minus-94 degrees F) and have a “GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment.” Pfizer also stated that once the vaccine is thawed, it can be stored at “refrigerated (2-8 degrees C) [about 35-46 degrees F] conditions” for up to 5 days.
While people at high risk, such as health care workers and other essential employees, along with the elderly, are expected to be the first to get the vaccine, it’s not yet clear when the rest of the population will receive it. According to the Centers for Disease Control and Prevention, “all adults should be able to get vaccinated later in 2021.”
While people wait for a vaccine to become available, experts emphasize continuing to wear face masks, practice social distancing and wash hands frequently.
“The FDA needs time to review all of the safety and efficacy data before they will issue the EUA,” says Goff. “We are almost at the finish line, but we must be patient.”
For the latest coronavirus news and updates, follow along at https://news.yahoo.com/coronavirus. According to experts, people over 60 and those who are immunocompromised continue to be the most at risk. If you have questions, please reference the CDC’s and WHO’s resource guides.
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