Albert Bourla, CEO of Pfizer, expressed his hope that full licensure would improve confidence in the shot. Since the emergency authorization in late 2013 was granted, more than 204 million doses have been given to Americans. The vaccine is widely used worldwide.
Albert Bourla, CEO of Pfizer, stated that today's approval for people over 16 confirms the effectiveness and safety profile our vaccine in an urgent time. As vaccination is the best tool to protect lives and attain herd immunity, I hope this approval will increase trust in our vaccine.
The vaccine has been approved for use by adults 16 years and older. It is also authorized for emergency use for children 12-15 years old. Pfizer, BioNtech and others are currently studying the safety and efficacy of the shot in infants and younger children. They expect to apply for emergency authorization this fall for 5-to-11 year-olds if all goes according to plan.
Moderna is another vaccine manufacturer. In June, it applied to FDA for full approval for its Covid-19 shot. The agency approved the shot for adults 18 years and older in late 2013. It is currently running clinical trials for its vaccine in children as young as six months.
"Full FDA approval for the Pfizer vaccine was another step forward to convince people to get vaccinated. It also facilitates mandates and saves more lives," tweeted Tom Frieden. Frieden led the Centers for Disease Control and Prevention under the Obama administration. Moderna's full approval should not be far behind, it's just a matter if timing and paperwork.
Johnson & Johnson is the third U.S.-based company to have a Covid-19 shot. It has stated that it will seek approval for full use later in the year.
Pfizer-BioNTech's shot is the first to use mRNA technology and be licensed by FDA for any type of disease. It relies on snippets mRNA (a type of genetic material) to instruct cells to produce harmless copies of coronavirus's spike proteins. The virus is protected by antibodies, which are produced by the body's immune system.
The U.S. government purchased 500 million doses Pfizer vaccine to use at home and 500 million to donate to countries in greatest need.
The FDA approved third doses of Pfizer's and Moderna vaccines earlier this month for individuals with compromised immune systems. This includes recipients of solid-organ transplants. Adults who have received one of the two mRNA vaccinations at least eighteen months ago will be eligible for booster doses from the Biden administration starting Sept. 20. To discuss the booster plan, the CDC's vaccine advisory panel is scheduled to meet this week.
However, some doctors and patients may be able to circumvent the FDA's decision not to fully license this vaccine. The Pfizer-BioNTech shot, like other approved drugs and vaccines can be prescribed "off-label" for unapproved uses. At the moment, this includes boosters for those who aren't immunocompromised or the initial vaccination of children under 12.
In a clinical trial, 95 percent of patients responded to the initial two-dose Pfizer-BioNtech vaccine. Recent research by the two companies showed that the vaccine's effectiveness dropped to around 84 percent after the second dose. Recent real-world research has shown that the two-shot standard regimen is less effective against the Delta variant of the virus than the earlier versions. This prompts the need for boosters in the U.S. as well as other countries.
According to a Mayo Clinic study, the effectiveness of the Pfizer BioNTech vaccine against Delta was reduced from 76 percent against Covid-19 strains to 42 percent against Delta. Data from Israel also showed that the shot's effectiveness against infection dropped from approximately 95 percent in June, to 64 percent in July when the Delta variant was introduced.
Most side effects are mild. In June, federal regulators began looking into reports of vaccine recipients experiencing heart inflammation. The vaccine safety panel of the Centers for Disease Control and Prevention determined that there was a "likely relationship" between vaccine and heart problems. These issues are usually rare and short-lived.
