Pfizer vaccine first to get full FDA approval | News, Sports, Jobs

A dose of the Pfizer-BioNTech vaccine is drawn from one of the first vials delivered to Maui in December. The U.S. Food and Drug Administration on Monday gave full federal approval to the Pfizer vaccine, making it the first of the three vaccines in the U.S. to receive the designation. The Maui News / MATTHEW THAYER photo

The federal government gave full approval to Pfizer-BioNTech’s COVID-19 vaccine on Monday, a move that state, health and business leaders hope will convince more Hawaii residents to get the shot as case counts continue to spike.

Previously on the U.S. market under an emergency use authorization, Pfizer’s version became the first of the three vaccines in the country to receive full approval from the U.S. Food and Drug Administration.

“I’m really hopeful for those (unvaccinated) people this will make a difference for them,” said state Health Director Dr. Libby Char during a news conference Monday afternoon.

Char said she’s heard most who refuse to get vaccinated say it was too soon for them to get the shot without more information, along with false claims that the vaccine was just “experimental.”

“I want to remind everyone this is the most studied, scrutinized, tracked vaccine in the history of mankind. We know it is safe, we know it works, it keeps people from severe illness, from hospitalization, from death,” Char said. “We know it works, so maybe this full FDA approval for those 16 and older will be enough to take those people who were hesitant and make them feel comfortable enough to go get vaccinated.”

As for how many might be willing to get the vaccine now, Char said, “I really don’t know. I’m hoping it’s a lot.”

As of Monday, 62 percent of Hawaii residents were fully vaccinated, according to DOH data. Maui County was at 56 percent, the lowest of all the counties. Leading the way is Honolulu City and County with 64 percent fully vaccinated, followed by Kauai County at 61 percent and Hawaii County at 58 percent.

On Aug. 5, Gov. David Ige issued his latest emergency proclamation that required all state and county workers to show proof of vaccination to their employers by Aug. 16. If workers are not vaccinated or show that they initiated the process, they are subject to weekly COVID-19 testing. Medical or religious exemptions are offered.

Maui County has mandated testing, not vaccinations, in hopes of incentivizing county workers to get the shot.

Ige said at the news conference on Monday that the data he has seen on vaccinations among state workers “was very encouraging.”

“The rate of vaccinations among the state employees is high, higher than I thought it would be initially,” Ige said, adding later that he did not have specific numbers.

“I think all of us really believe that public servants would choose to get vaccinated. We’ve seen public servants step up for the entire pandemic and they have been willing to go beyond the call in their duties, accepting responsibilities that are out of their scope they know that would help support our communities,” Ige said.

Officials with Maui Health, which operates the island’s only acute-care hospital, Maui Memorial Medical Center, said they are also hopeful that full FDA approval of the Pfizer vaccine will help more to get the shot as well as help employers feel more comfortable with getting their staff to be vaccinated.

“The FDA’s approval affirms what we as medical professionals have known for some time — these vaccines are safe and effective,” said Dr. Michael Shea, intensivist and chief medical director for Maui Health.

Michael Rembis, CEO of Maui Health, added: “Now that the Pfizer vaccine has full FDA approval, like the flu shot, we hope this gives people confidence in the vaccine and more people step forward to get vaccinated.”

He reminded the public of the hospital’s vaccination clinic, which is also offering a third dose of the vaccine for those who quality. For details and clinic hours, visit mauihealth.org/covidvaccine.

“The full approval may lead to more employers to feel comfortable mandating the COVID-19 vaccine for their employees,” Shea added. “Many organizations and business leaders have been waiting for this approval to move forward with new policies and processes.”

Maui Chamber of Commerce President Pamela Tumpap said in a text message on Monday that the chamber is “thrilled” with the decision and hopes that approvals for the other vaccines will follow.

She said this assures the public that rigorous scientific protocols were met and the vaccine meets high standards for safety, effectiveness and manufacturing quality.

“This can be shared with current and potential employees,” she said.

The FDA’s announcement and future approvals of other vaccines might make it easier for those who didn’t want to institute a vaccination policy to reconsider.

The chamber recently launched a member survey in which “very early results” from 20 respondents show that 50 percent of employers said they are considering a similar program as the state, requiring that employees either be vaccinated or tested weekly, while 45 percent said they are not interested in implementing such a policy.

With cases continuing to rise, residents not following rules and hospitals filling up — including Queen’s West Oahu, which declared an internal emergency Friday as it reached capacity — Ige acknowledged that a lockdown could happen.

“Is a lockdown on the table? Yes, it would be if the number of cases continues to grow exponentially as it has in the last 10 weeks as Dr. Char has said. Then we will have to take action to limit and ensure that hospitals are not overwhelmed,” Ige said, adding that there is no specific number of cases or sick patients that would automatically trigger the lockdown.

But Ige said officials are “in contact with the hospitals every single day about their current situation about the number of patients they are seeing and about their capacity to continue to serve our community with quality health care.”

He added that there are surge plans, which could include using the Hawaii Convention Center.

In the meantime, the DOH has ramped up testing, increased isolation and quarantining facilities and tried to increase contact tracing, Char said. But she also asked residents to also take responsibility.

“We need to back down from our gatherings,” she said.

She added that people need to say at home if they are sick, as well as wear their masks and practice the safety protocols.

As Honolulu City and County on Monday announced a suspension of large gatherings for four weeks beginning Wednesday, including weddings, funerals and sporting events, Ige said he is continuing his talks with Mayor Michael Victorino on his proposals for restrictions. Ige is also reviewing proposals from the mayors of Kauai and Hawaii island.

The governor said he is also requesting that people not travel to Hawaii because of the COVID spread and strain on the hospitals, pointing out to visitors that they will not have the usual Hawaii experience if they come now, as there is a shortage of rental cars and restaurants are at limited capacity. He has also reached out to travel industry officials, including airlines, about the surge in the state.

* Melissa Tanji can be reached at mtanji@mauinews.com.