FDA gives full approval for Pfizer vaccine, Bay Area leaders say acceptance and warrants could follow

Bay Area health experts and civic leaders have expressed enthusiasm and relief that the federal government has given full approval to Pfizer’s COVID-19 vaccine on Monday, a step that could boost public confidence in the shootings and get more businesses, universities and local governments to make vaccinations mandatory.

“This is good news,” said Dr. George Rutherford, an infectious disease expert at the University of California, San Francisco. “This removes an objection and legal barriers to a vaccine requirement.”

Approval applies to shots for persons 16 years of age and older. The Pentagon immediately announced that it would continue its plan to require 1.4 million active-duty military personnel to be vaccinated. San José also became the last local jurisdiction to impose a warrant on city employees.

“It will have a huge effect on the Bay Area because there are large swathes of California right next to us that have very low vaccination rates and our borders are porous,” said Peter Chin-Hong, professor specializing in infectious diseases at UCSF.

Prior to Monday, the Pfizer vaccine was used under the FDA’s Emergency Use Clearance designation, an expedited review process invoked during public health emergencies. Full approval involves more rigorous review, including inspections of manufacturing facilities.

The formula developed by Pfizer and its German partner BioNTech now enjoys the strongest approval from the Food and Drug Administration, which has never had so much evidence to judge the safety of a shot.

“This approval will push federal agencies, workplaces and schools to impose the vaccine,” said Michael Stanton, professor of public health at California State University East Bay. “It will make it safer for society. It will also make the debate less. Over time, we will hear less and less debate as people are forced to either keep their jobs or not get vaccinated. “

Bay Area officials used the announcement to step up their call for universal uptake of immunization.

“I’ve heard people waiting for ‘full approval’ from the FDA to get a COVID vaccine,” San Francisco Mayor London Breed tweeted. “Well, today that’s what happened with the Pfizer vaccine. Dating is widely available and you can go get shot today.



San Mateo County Supervisor David Canepa echoed this message.

“You would be amazed how many times people would say they wouldn’t get the vaccine because it wasn’t FDA approved,” he said. “Now is the time to get vaccinated if you don’t. “

More than 200 million doses of Pfizer have been administered in the United States – and hundreds of millions more around the world – since December.

Yet many remain on the fence about immunization. A common concern is the perception that the vaccine is still too new and has been rushed. Health officials are hopeful that FDA approval can allay some of these concerns.

“We hope this approval will build confidence in those who hesitated,” Acting FDA Commissioner Janet Woodcock said at a press briefing Monday, announcing the full approval, which comes as states United are fighting the most contagious coronavirus mutant to date, the delta variant.

The delta variant has skyrocketed COVID-19 cases, deaths and hospitalizations in recent weeks in the United States, erasing months of progress against the coronavirus.

“For weeks we have seen cases increase at an alarming rate among individuals who are not vaccinated while the vaccinated are largely protected,” said Dr. Tomas J. Aragon, director of the California Department of Public Health. “If you are not vaccinated, then this is the step that gets you there.”

FDA action may also lead to more immunization mandates covering students, employees, and customers, making it easier to demand a safety case.

Stanton said some estimates show that about 5% of the U.S. population are waiting for full FDA approval to get vaccinated.

“It’s a huge portion of the population that interacts with other Americans – going to grocery stores, schools and workplaces, exchanging air with others,” he said. “Every percent we can increase has an almost exponential effect in stopping the spread of the virus.”

Many mandates from California universities and public employers to have their workers vaccinated did not await FDA approval, so Monday’s announcement has little impact on those existing policies. But there are a few exceptions, including the city of San Francisco, whose vaccination requirement for 35,000 city employees is dependent on FDA approval. City employees should be vaccinated before November, unless they have a medical or religious exemption.

“I think the overall percentage of people vaccinated in the Bay Area will increase slightly because we are starting at such a high point,” Chin-Hong said. “But in some communities, especially communities of color, where the rates are low, it will bring about a change as immunization will be tied to the economy.”

U.S. vaccinations hit a low in July with an average of about half a million vaccines per day, up from a peak of 3.4 million per day in mid-April. As the Delta variant fills hospital beds, shots are on the rise again, with one million a day given Thursday, Friday and Saturday.

Just over half of the American population is fully vaccinated with one of the country’s three options, from Pfizer, Moderna, or Johnson & Johnson. About 55% of Californians are fully vaccinated. Bay Area rates are higher with most local counties 70% fully vaccinated.

Moderna has also asked the FDA for full approval of its vaccine. J&J has said he hopes to do so later this year.

Pfizer CEO Albert Bourla said in a statement that he hoped the move “will help increase confidence in our vaccine, as vaccination remains the best tool we have to protect lives.” The snapshot will now be known in the United States under the brand name Comirnaty.

Full approval means Pfizer’s COVID-19 vaccine meets the same “very high standards required of all approved vaccines we rely on every day,” said Dr Jesse Goodman of Georgetown University, a former chief vaccines from the FDA. This should help “anyone who still has concerns to gain confidence” in the shots.

This month, New York City, New Orleans and San Francisco all imposed proof of vaccination requirements in restaurants, bars and other indoor locations. At the federal level, President Joe Biden is requiring officials to sign forms certifying that they have been vaccinated or to submit to regular tests and other requirements.

Anxious Americans are increasingly on board: Nearly 6 in 10 support requiring people to be fully immunized to travel on planes or attend crowded public events, according to a recent Associated Press poll. NORC Center for Public Affairs Research.

The FDA, like regulators in Europe and much of the world, initially cleared the emergency use of Pfizer’s vaccine based on a study that followed 44,000 people aged 16 and over for at least two months – the period during which severe side effects usually occur.

This is shorter than the six months of data security normally required for full approval. So Pfizer continued with this study, and the FDA also looked at the actual safety evidence in deciding to fully authorize the vaccine for people 16 years of age and older, those who have been studied the longest. Pfizer’s shot still has an emergency clearance for 12-15 year olds.

Even after hundreds of millions of injections, government monitoring shows serious side effects are still very rare, such as chest pain and heart inflammation within days of the second dose, mostly in young men.

Regarding efficacy, six months after the start of the original Pfizer study, the vaccine remained 97% protective against severe COVID-19. Protection against milder infections declined slightly, from a peak of 96% two months after the second dose to 84% in six months.

This data came before the extra-contagious delta variant began to spread, but other data from the Centers for Disease Control and Prevention shows that the vaccine still does a good job of preventing serious illnesses caused by this mutant.

As with all discussions of booster doses, the FDA clearance does not cover them. The agency will decide this separately.

The FDA is already authorizing emergency use of the third dose of the Pfizer or Moderna vaccine for people with severely weakened immune systems, such as organ transplant recipients or cancer patients. For anyone who has received these vaccines, the Biden administration is planning boosters starting in the fall, if the FDA and CDC agree.

Pfizer and Moderna are both studying children under 12, with data expected in the fall.

The Associated Press contributed to this report.

Chronicle editor Trisha Thadani contributed to this report.

Aidin Vaziri and Catherine Ho are the editors of the San Francisco Chronicle. Email: [email protected] [email protected]

Source link

About Christian M.

Check Also

Denver State Broncos offense | Diagnose the solution

The Denver Broncos started the season with an offense that had a lot of talent …