The COVID-19 pandemic turned a corner over the weekend, as the federal Food and Drug Administration authorized the first vaccine in the U.S., and distribution began to California and the other 49 states.
The FDA granted emergency use authorization for Pfizer and BioNTech's COVID-19 vaccine December 11, the first to get the green light in the United States. The United Kingdom and Canada also recently approved the vaccine.
The nighttime announcement — reportedly rushed out after White House chief of staff Mark Meadows threatened FDA commissioner Dr. Stephen Hahn's job if the authorization didn't happen Friday — came the day after an expert advisory committee voted overwhelmingly that the benefits of the vaccine outweigh its risks.
"Today's action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency's career scientists to ensure this vaccine met FDA's rigorous, scientific standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization," Hahn said in a statement.
An advisory committee hearing for a second vaccine from Moderna and the National Institutes of Health is scheduled for December 17, and authorization could come the following day.
In a video posted to Twitter after Friday night's announcement, Governor Gavin Newsom said the authorization is "very encouraging news," adding that "327,600 doses of the vaccine on their way to the state of California."
The multi-state COVID-19 vaccine review group that California announced in October unanimously confirmed the Pfizer vaccine is safe after conducting its own concurrent and thorough review, Newsom's office stated Sunday. In addition to the Golden State, officials from Oregon, Washington, and Nevada participated in the review.
"Our Western States Scientific Safety Review Workgroup has worked concurrently with the federal process to review and assess available data, and examine the federal review processes regarding the safety and efficacy of the Pfizer COVID-19 vaccine," Newsom stated. "This morning, the workgroup recommended the Pfizer vaccine as safe for public use. With shipments of the vaccine soon on their way to California, we are working hand-in-hand with local public health officials to get the vaccine out to the first phase of recipients. Their work will continue as data becomes available on other potential vaccines."
Clinical trial results
The Pfizer/BioNTech and Moderna vaccines use a novel mRNA approach. Nanoparticles, or fat bubbles, deliver bits of viral genetic material that encode instructions for making the SARS-CoV-2 spike protein, which the coronavirus uses to enter human cells. When injected into a muscle, the cells produce the protein, triggering an immune response. The mRNA degrades quickly in the body and it does not interfere with human genes.
The Pfizer/BioNTech vaccine was tested in a phase 3 clinical trial that enrolled a diverse population of more than 43,000 volunteers, including some in the Bay Area. Participants were randomly assigned to receive two injections of the vaccine or a placebo spaced three weeks apart.
The vaccine was 95% effective at reducing the risk of symptomatic COVID-19. A total of 170 cases were observed: 162 in the placebo group and just eight in the vaccine group. Of the 10 reported cases of severe COVID-19, nine were in the placebo group. A protective effect was apparent starting 10 days after the first dose, and the initial dose alone reduced the risk by about half.
The vaccine was effective across all demographic groups, including people over age 65 — important because older people, who are at greatest risk for severe COVID-19, tend to mount a weaker immune response to vaccines.
One hundred and twenty people with HIV were added later in the study and were not included in the analysis. But HIV-positive people are eligible to receive the vaccine, and experts do not foresee any additional safety concerns. "Since [it's] not a live vaccine and no biological reason to be concerned about HIV, [I] would recommend those with HIV be vaccinated," Dr. Monica Gandhi, medical director of Ward 86, the HIV clinic at Zuckerberg San Francisco General Hospital, wrote on Twitter.
The vaccine is authorized for people age 16 and up, although only a small number of 16- and 17-year-olds were included in the trial. A study for adolescents ages 12 to 15 is underway, and studies of younger children are planned. Another study will test the vaccine in pregnant people, but in the meantime, they are eligible for the vaccine and no safety concerns are expected.
It is not yet clear whether the vaccine will prevent asymptomatic infection or transmission of the coronavirus. Trial volunteers were not tested regularly to see whether they had been infected; they were only tested if they developed symptoms. It is also not yet known how long vaccine-induced immunity — or natural immunity — will last. People who have already had COVID-19, or suspect that they have, can still get the vaccine and it may offer additional protection.
The vaccine was generally safe, though many study participants experienced mild to moderate side effects, especially after the second dose. More than 80% had injection site reactions such as soreness. Other common symptoms included fatigue, headache, muscle and joint pain, chills, and fever, which usually lasted no more than two days. Flu-like symptoms are not unusual after receiving vaccines and are an indication that the immune system is working.
Days after the vaccine was rolled out in the U.K., two National Health Service workers with a history of prior vaccine reactions experienced allergic reactions; both were treated and recovered. Responding to concerns, the U.S. Centers for Disease Control and Prevention clarified that people who have had prior reactions to vaccines or injectable drugs can still get the new vaccine, but they should discuss the risks with their care provider and should be monitored for a half hour after administration. People with other types of allergies do not need to take special precautions.
Rollout challenges
COVID-19 vaccine development has proceeded with unprecedented speed. Early in the pandemic, National Institutes of Health director Dr. Anthony Fauci predicted that a vaccine could be available in 12 to 18 months, but Friday's authorization beat even that optimistic timeline.
The initial limited vaccine supply will go to health care workers and residents of long-term care facilities, according to a CDC advisory committee. Other priority groups include frontline essential workers who are at high risk for coronavirus exposure and people over age 65 and those with underlying health conditions that put them at risk for severe COVID-19 and death. Younger adults with no particular risk factors could start getting vaccinated this spring. States and local jurisdictions will make final decisions about vaccine allocation.
Rollout of the vaccine is now underway, a process fraught with logistical challenges because it requires ultra-cold refrigeration at minus 94 degrees Fahrenheit. The U.S. has contracts with Pfizer for 100 million doses, which will cover 50 million people. An initial allotment of 2.9 million doses is already being shipped around the country.
Newsom said California expects to receive more than 2 million doses by the end of the year, which would come close to covering the state's health care workforce and nursing home residents. San Francisco officials are planning to get about 12,000 doses early this week, and other Bay Area cities will also receive allotments.
Most experts expect that herd immunity could occur after around 70% of people have been vaccinated. At that point, there would be too few susceptible people for the virus to spread easily.
"If we get 60% to 70% of people vaccinated with a vaccine that's more than 90% effective, we probably will reach a point that's pretty close to herd immunity, where the virus just can't find enough mouths and noses that aren't immune, and then it starts dying out," UCSF's Dr. Bob Wachter told the Bay Area Reporter last month.
Until then, it will still be important to keep up precautions to prevent COVID-19 such as wearing face coverings and maintaining physical distance.
"[W]ith tonight's FDA authorization, we must ensure that the vaccine will be free and distributed in a fair and equitable manner to as many Americans as possible as soon as possible," House Speaker Nancy Pelosi (D-San Francisco) said in a statement. "We must accelerate its manufacture, including by invoking the Defense Production Act. With vaccine distribution being administered by the states, state and local funding is also central to our efforts to crush the coronavirus. Until the vaccine is widely available, it is essential that we continue to embrace the testing, tracing, treatment, mask wearing and social distancing that are essential to preventing thousands of Americans from dying every day from the pandemic."
As of Sunday, nearly 300,000 people in the U.S. have died from COVID-19.
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