Mass. issues updated mask guidance; Baker calls on FDA to give vaccines full approval

Brian Allen smiled after receiving a COVID-19 vaccine at a pop-up clinic in Copley Square on Thursday afternoon.Christiana Botic for The Boston Globe

The Baker administration on Friday released updated guidance on wearing masks following new recommendations this week from the Centers for Disease Control and Prevention and the rise of the highly transmissible Delta variant, with Governor Charlie Baker calling the guidance “simpler” than the CDC recommendations even as he urged the federal government to speed up full FDA approval of the vaccines.

The state now recommends that fully vaccinated people wear masks indoors “if you have a weakened immune system, or if you are at increased risk for severe disease because of your age or an underlying medical condition, or if someone in your household has a weakened immune system, is at increased risk for severe disease, or is unvaccinated,” the department said in a statement.

Those who are unsure if they qualify as at “increased risk” for severe COVID-19 should speak with their doctors, the statement said. It also directs people to consult a list of conditions identified by the CDC that can increase risk for the virus.

The guidance is a departure from the CDC’s advice, which recommended masks based on community transmission rates rather than specific groups of people, and stops short of a mandate. On Tuesday, the CDC recommended that vaccinated people return to wearing masks indoors in parts of the country that are experiencing “substantial” or “high” COVID-19 transmission. In Massachusetts, that applies to five counties: Barnstable, Bristol, Dukes, Nantucket, and Suffolk.

In Massachusetts, masks are still mandatory for people on public transportation, in health care facilities, and in congregate care facilities, among other certain places, the statement added.

With COVID-19 cases rising in Massachusetts, Baker has faced pressure to update mask guidance in the state. Some cities and towns, including Cambridge, Provincetown, and Nantucket have acted on their own and urged or required people to wear masks indoors.

During an event to encourage youth vaccination in Roxbury Friday, Baker defended his administration’s decision to issue statewide recommendations instead of repeating the CDC’s county-specific approach, saying he think it is “simpler” and “more straightforward.”

“Part of the reason why we believe we should do statewide guidance is, what if you live in one county, work in another?” Baker said. “What if you work in one county, live in another? What if you decide to go [on] vacation or out to dinner in one county and live in another?”

Baker added that state officials are working to protect those “who have the most to lose here” like the elderly, and others who are at higher risk of serious disease from COVID-19.

“And the same goes if you live with, have family members, work with, or have friends who have similar kinds of medical conditions. That guidance, I believe, is a lot simpler and a lot easier and a lot more straightforward.”

Dr. Helen Boucher, an infectious disease physician at Tufts Medical Center and interim dean of the Tufts University School of Medicine, said she thought the new guidance was “a really well thought-out decision.” Baker’s approach, Boucher said, differs from the CDC’s in that it takes into consideration Massachusetts’ vaccination and transmission rates.

“We have high levels of vaccination and lower levels of transmission,” Boucher said. “Of course, we’re not happy that those levels are higher here recently, but they’re still not like what’s being seen in places like Alabama and Mississippi, for example. The governor took the status of the epidemic in our state into account as he made his recommendations, and that’s great. That’s how it should work.”

The Massachusetts Medical Society went a step further than Baker’s new guidance. Its physicians “strongly recommend” that people wear masks in indoor, public places when social distancing isn’t possible, regardless of vaccination status, Dr. Carole E. Allen, the society’s president, said in a statement.

“Masking is proven to reduce community transmission of COVID-19 and slowing the spread of the virus is critical, as the Delta variant drives a concerning uptick in key public health metrics across Massachusetts and the nation,” the statement said.

Baker also criticized the Food and Drug Administration Friday for not yet granting full authorization for the vaccines in use in the United States. The agency has granted emergency use authorization for three COVID-19 vaccines, each developed by Pfizer-BioNTech, Moderna, and Johnson & Johnson.

“I am one of many governors, Democrats and Republicans, who believe when you get to the point where you’ve delivered 400 million shots of vaccine that have the kind of results that these vaccines have demonstrated, and you are concerned as we are about the Delta variant, where’s the urgency at the federal level on this one? Where is it?” Baker said.

Baker added that full approval from the FDA would make “a really big difference” in boosting vaccination rates.

“I hear from people all the time who say to me, ‘I’d really like to see that thing get final approval.’ And I don’t blame them. I would too. I think it would make a really big difference,” he said.

Baker called on the FDA to put “urgency” into granting full approval to the vaccines.

“I would love to see the FDA finish their process, put the urgency into it that we all believe it deserves, recognize and understand that 400 million shots later, and a ton of evidence, that it makes a positive difference in the lives of those who’ve chosen to get vaccinated, that it would help,” Baker said. “And there’s plenty of data there to support it.”

Boucher said she agreed that full approval would improve vaccination rates, but cautioned that the agency “has an obligation to do the complete safety and efficacy analysis of the data that was submitted to them.”

But while some have suggested full approval would make it easier for employers and other institutions to mandate vaccinations, thus helping boost overall rates, one lawyer said the distinction between emergency use authorization and full FDA approval of the vaccines does not impact whether employers can mandate vaccinations for employees to return to the office.

Brian Richichi, an employment litigator at Boston law firm Krokidas & Bluestein, has been advising clients on COVID-related issues.

The argument that emergency use authorization prevents employer vaccine mandates has to do with the condition of informed consent that is tied to the COVID-19 vaccines under emergency approval, Richichi said. When a person receives a COVID-19 vaccine, they are told that they have the right to decline the vaccine.

“That requirement that you have a right to decline is not the same as whether or not an employer has the right to mandate a vaccine,” Richichi said, “because when an employer is mandating a vaccine what they’re really saying is ‘only vaccinated people are allowed into the workplace.’ So it’s not that they’re forcing you to get it, but that being vaccinated is essentially a job qualification for holding that job.”

An opinion from the Department of Justice’s Office of Legal Counsel that said emergency use authorization does not prevent employers from mandating vaccines as well as recent mandates set by schools, colleges, and the Department of Veterans Affairs have made it clear that vaccines approved for emergency use can be mandated, Richichi said.

Massachusetts has among the highest vaccination rates in the country, with 63.7 percent of its population fully vaccinated, according to CDC data, but in recent weeks, COVID-19 cases have increased. The state has averaged about 428 confirmed cases over the past week, according to data from the DPH.

Also on Friday, the state issued new guidance on wearing masks in schools, recommending that unvaccinated students, educators, and staff members wear masks indoors this fall despite federal recommendations earlier this week that called for everyone in school buildings, regardless of vaccination status, to wear masks.