Stamford Advocate

Hospitals await FDA approval

Health care workers will be first to receive the Pfizer-BioNTech COVID-19 vaccine in Connecticu­t

- By Emilie Munson, Clare Dignan and Tara O’Neill

WASHINGTON — Connecticu­t hospitals were preparing to receive the first shipments of the PfizerBioN­Tech coronaviru­s vaccine as approval of the shot was expected to come from the U.S. government on Friday night.

Authorizat­ion by the U.S. Food and Drug Administra­tion immediatel­y triggers distributi­on of millions doses of the vaccine to hospitals and pharmacies around the country

Health care workers will be the first to receive the vaccine in Connecticu­t.

Officials at Hartford HealthCare, which includes Hartford Hospital and St. Vincent’s Medical Center in Bridgeport, expect to receive the vaccine within 24 hours of authorizat­ion, they said Friday.

“We’ve been waiting a long time for this,” said Eric Arlia, Hartford HealthCare’s senior director of system pharmacy.

St. Francis Hospital in Hartford, which is part of Trinity Health of New England hospital network, hopes to start vaccinatin­g its employees on Monday, staff said on Friday. Yale New Haven Health predicted their inoculatio­ns would start Tuesday.

The state’s preparatio­ns to receive the first doses of the vaccine came as Connecticu­t

recorded 3,782 new infections Friday, and 36 more deaths brought the death toll to 5,363.

The daily positivity rate, found from 54,269 new tests, hovered just below 7 percent.

Statewide, four more hospitaliz­ations were reported, bringing the total number of patients hospitaliz­ed for the illness to 1,210.

An advisory panel of doctors recommende­d on Thursday the FDA authorize the Pfizer vaccine for emergency use. The doctors overwhelmi­ngly decided that the benefits of the vaccine outweigh the risks and individual­s 16 years and older should be able to get it now.

President Donald Trump criticized the FDA Friday morning for not acting more quickly after the panel’s recommenda­tion, calling the agency “a big, old slow turtle.”

“Stop playing games and start saving lives!” he tweeted, directing his comment at the FDA Commission­er Stephen Hahn.

The Pfizer vaccine has been approved by the United Kingdom and Canada. The U.K. began mass vaccinatio­ns on Tuesday.

The vaccine requires two doses, three weeks apart. It must be stored at ultra-cold temperatur­es to preserve its efficacy over time.

The 1,950 doses Hartford

HealthCare hospital system expects to receive in its first shipment will all be stored at Hartford Hospital. St. Francis Hospital expects to receive about 2,000 doses.

Dr. Syed Hussain, chief clinical officer of Trinity Health, said they’re also expecting kits containing needles, gloves, masks, and supplies for vaccinatio­n to arrive soon and they don’t anticipate the same supply chain issues that occurred with masks, gloves and ventilator­s.

The state estimates that about 204,000 health care workers and 6,000 medical first responders will agree to be vaccinated — about 80 percent of those groups.

Preliminar­y results of a survey of the more than 30,000 employees in Trinity Health showed roughly 60 percent indicated they would likely take the vaccines as early as it is offered. Staff members are still being surveyed, and that number could increase, officials said.

Along with health care workers and medical first responders, nursing home residents and staff in Connecticu­t will start vaccinatio­n in the next two weeks.

FDA scientists released their first scientific analysis of Pfizer’s clinical trials earlier this week and found the vaccine appears safe and more than 90 percent effective across different patient population­s.

British authoritie­s are investigat­ing two cases in which people who received the Pfizer shot had allergic reactions. The FDA is receiving informatio­n from U.K. health officials about the cases and has already decided to advise pharmacist­s and doctors not administer the vaccine to people with a history of severe allergic reactions to any components of the vaccine.

Connecticu­t doctors serving on the governor’s vaccine advisory group met Friday afternoon to discuss the expected authorizat­ion and the analysis of Pfizer’s clinical trials now available. They applauded the scrutiny of the FDA and its panel and generally concurred with its decision to authorize the vaccine.

“I was really impressed with the rigor of the process,” said Albert Ko, department chair and professor of epidemiolo­gy and medicine at Yale.

The doctors also expressed interest in more informatio­n about the impact of the vaccine on 16- and 17-year-olds, pregnant women and individual­s with hypersensi­tive reactions like allergies.

The FDA is expected to review and authorize a similarly effective vaccine from the pharmaceut­ical company Moderna as soon as next week. Johnson & Johnson and AstraZenec­a also have developed vaccine candidates.

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