The formal approval of the Pfizer-BioNTech COVID-19 vaccine could be a key turning point in the response to the California pandemic, opening the doors to a major wave of vaccinations.
The state has already established an aggressive response to the pandemic, with a large number of agencies and institutions putting in place strong vaccination policies, including inoculation requirements for educators and healthcare workers.
However, experts say the approval of the vaccine by the Food and Drug Administration (FDA) on Monday could be a change that will jumpstart the effort.
“This landmark FDA approval … is an important certification of the efficacy and safety of the vaccine that should dispel any doubts for people who are still reluctant to vaccinate,” said Dr. Robert Kim-Farley, medical epidemiologist. and an infectious disease expert from UCLA’s Fielding School of Public Health.
Although many people – about 25 million in California alone – did not need the FDA seal of approval to apply it, more than 35% of the state’s population remains unvaccinated, according to The Times tracker.
Many of those people cited authorization for emergency use of the vaccine as a reason for not getting vaccinated.
Experts note that Monday’s move will likely allay some of those concerns, leading to an increase in vaccinations. But the biggest boost could come from tougher policies.
“It will come hand in hand with mandates,” said Dr. Peter Chin-Hong, a professor of medicine and infectious disease specialist at UC San Francisco, noting that some schools, employers and government agencies have already begun to introduce such policies. “It will lead more private and public sector companies to demand vaccines after this full approval.”
In fact, some cities and counties have linked vaccination mandates to FDA approval. The 36,000 city employees of San Francisco were told they will have 10 weeks to get vaccinated after the FDA approved at least one of the vaccines.
Pasadena already requires its employees to get vaccinated, but the city had been allowing temporary deferrals for those awaiting FDA approval, which is now invalid. Orange County cities, such as Santa Ana and Irvine, have also announced plans to require vaccinations for all municipal workers.
Other areas have made even less concessions. The Los Angeles City Council voted last week to require the vaccine for all city employees, without the option of regular testing.
And the Los Angeles County Board of Supervisors passed an executive order requiring all 110,000 county employees – including those in the sheriff and fire departments – to be fully vaccinated by Oct. 1.
The City of Los Angeles is also weighing vaccination requirements for restaurants, stores, gyms, bars, and other public spaces.
FDA approval comes at a crucial time for California and the country: The highly transmissible Delta variant has hit the state for months, and concerns about a fall full of masks and anxiety are mounting. Los Angeles County surpassed 25,000 deaths from COVID-19 last week.
Yet many of the state’s residents remain deeply divided. Parents and consumers are locked in battles over mask-wearing mandates and vaccine requirements even when children have returned to school, while many workplaces and public venues try to determine whether they should welcome people. and how to do it.
Many opponents claim that vaccination mandates are a form of government overreach or even discrimination, especially as there are more and more off-limits for the unvaccinated.
Although the issue has been debated, Michele Goodwin, a law professor at the University of California at Irvine and director of the Center for Biotechnology and Global Health Policy, said that most vaccination requirements are legally sound, especially in light of the authorization from Monday.
“Since 1905, the United States Supreme Court has said that municipalities – that is, the government – can impose vaccination requirements on individuals,” he said, noting that the court has confirmed other opinions on the matter.
And the private sector has an even stronger foundation when it comes to vaccination policies, Goodwin said, such as when restaurants establish dress codes for workers. Those policies are acceptable as long as they do not discriminate against protected classes such as race, gender, disabilities, or sexual orientation.
“Employers can set the conditions of employment,” he noted.
More people will need to be vaccinated to protect the most vulnerable, such as children and severely immunosuppressed individuals. (FDA approval currently applies to those 16 years of age and older, and no emergency authorization has yet been granted for those under 12 years of age.)
Authorities hope the FDA announcement will send a strong signal about the safety of the vaccine, which had to meet stringent regulations to be approved.
“For weeks we have watched as cases increase at an alarming rate among people who are not vaccinated, while those inoculated are widely protected, especially against serious and long-lasting diseases,” said Monday the director of the Department of Public Health from California, Tomás Aragón, in a statement.
COVID-19 case rates remain much higher among those who have not received the vaccines than among those who are inoculated, despite some progress in infections. As of Aug. 17, less than 1% of the 5.1 million vaccinated people in Los Angeles County had tested positive for COVID-19, according to authorities. Of those who were fully vaccinated and tested positive, 0.014% were hospitalized and only 0.0013% died.
Meanwhile, ICUs continue to fill with uninoculated people who become ill and die from the virus. Hospitalizations for unvaccinated young adults ages 18 to 49 have increased 226% since July 7, according to county officials.
The FDA approval of Pfizer’s vaccine has other implications, experts say, including the potential for off-label uses, such as doctors giving extra doses to patients who are not generating responses. strong immune systems.
It also gives Pfizer the green light for direct-to-consumer marketing, and the vaccine already has a brand name: Comirnaty.
But most agreed that the emphasis in the coming weeks will be on other approvals – for other vaccines and additional age groups – and new terms.
“The FDA approval of Comirnaty will empower employers and schools to institute mandates for a vaccine that is fully approved, as has been done in different settings for vaccines like measles,” said Kim-Farley.
To read this note in English Click here
–
