Pfizer COVID-19 Vaccine Receives Full FDA Approval


More businesses may require workers to get vaccinated against the coronavirus now that the U.S. Food and Drug Administration (FDA) has fully approved the Pfizer-BioNTech vaccine.

Pfizer's is the first COVID-19 vaccine in the U.S. to receive full licensure from the FDA, which public health experts said might make it easier for employers to mandate the shot. Following the announcement, the City of New York announced that all education staff, including teachers and administrators, must be vaccinated by Sept. 27. 

About 62 percent of adults were fully vaccinated as of Aug. 22, according to the U.S. Centers for Disease Control and Prevention (CDC), but the fast-spreading delta variant has caused a surge in COVID-19 cases this summer. Cases in the U.S. recently surpassed 130,000 a day on average, following a drop in June to about 12,000 new cases each day. 

"We still largely are in a pandemic of the unvaccinated," said CDC Director Rochelle Walensky, though she cautioned that, in rare cases, fully vaccinated people may experience breakthrough infections. It is expected that Moderna's vaccine also will receive full FDA approval soon.

President Joe Biden has urged businesses to require employees to get vaccinated and said that the federal government will continue to support employers that do. 

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We've rounded up articles and resources from SHRM Online and other trusted media outlets on the news.

Pfizer Executive Hopes for Increased Confidence

The Pfizer vaccine was previously approved under emergency use authorization. To obtain full licensure, the company must provide more information about the manufacturing process and submit to in-depth FDA inspections. "Based on the longer-term follow-up data that we submitted, today's approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed," said Pfizer chief executive Albert Bourla in a press statement. "I am hopeful this approval will help increase confidence in our vaccine."

The FDA's full approval could create a new wave of vaccine mandates from employers and universities to help curb the sharp increase in new COVID-19 infections fueled by the delta variant.

(The Washington Post)

U.S. Military Service Members Must Get Vaccinated

After the FDA gave full approval to the Pfizer vaccine, the Pentagon announced that it will send guidelines to the 1.4 million active-duty service members who will be required to get vaccinated. More states, universities and large employers also are planning to mandate vaccines in light of the news.

(The New York Times)   

Moderna May Be Fully Approved Soon

The FDA is still reviewing Moderna's application for full approval of its COVID-19 vaccine. Regulators could reach a decision in the next few weeks.

(The New York Times)

Rollout of Booster Shots to Begin Soon

The U.S. Department of Health and Human Services and leading government health officials announced Aug. 18 that people who received the Pfizer and Moderna vaccines are advised to get a booster shot to improve their immunity to COVID-19. The booster shots should be received eight months after individuals got their second vaccine and are scheduled to become available in September.

U.S. Surgeon General Dr. Vivek Murthy told CNN Sunday that recipients of the Johnson & Johnson vaccine may need a booster, but the government needs more information before issuing a recommendation. The government is "waiting on some data from the company about the second dose so the [Food and Drug Administration] can fully evaluate the safety and efficacy of that dose," he said.

(SHRM Online) and (Forbes)

Employers Can Help Achieve COVID-19 Herd Immunity

Employers have a critical role to play in helping their employees access accurate information and making it easier for them to get vaccinated, said Andy Slavitt, former senior advisor for the White House COVID-19 Response Team. HR can help motivate more people to get vaccinated by providing reliable and accurate information. HR professionals know that people make decisions at different paces, he noted. Some people booked vaccine appointments as soon as they were available, while others needed more time to review the data before deciding.

(SHRM Online)

Developing a COVID-19 Employee Vaccination Policy

Employers grappling with whether to require their workers to be vaccinated against COVID-19 as well as other infectious diseases may benefit from the process that Houston Methodist, an academic medical center comprising eight hospitals in Houston, used to make that decision. On March 31, the organization mandated that their 26,000 employees, with some exceptions, be vaccinated, making it the first U.S. hospital system to do so. On June 12, a judge dismissed a lawsuit filed by 117 workers who challenged the mandate. "With our policy having stood this legal test, we believe that other employers can use our process for developing a vaccination policy of their own," according to Houston Methodist leaders. They said this 7-step process can help employers decide whether to mandate vaccinations.

(SHRM Online)

[Want to learn more about COVID-19 and workplace safety? Join us at the SHRM Annual Conference & Expo 2021, taking place Sept. 9-12 in Las Vegas and virtually.]

Should Employers Pay for Unvaccinated Workers to Get Tested?

High transmission rates of the COVID-19 delta variant led many employers—including the federal government, some state governments and large companies—to revise their COVID-19 safety policies. For example, federal employees must be vaccinated or submit to weekly or twice-weekly COVID-19 testing and other workplace safety requirements. California was the first state to announce that health care workers and state employees must follow a similar mandate, and more states and cities recently followed suit. As more employers require their workers to get vaccinated or submit to regular COVID-19 testing, they may have questions about who pays for testing when workers refuse to get vaccinated. Here are some points for employers to consider as they develop their testing policies and practices.

(SHRM Online)



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