San Antonio Express-News (Sunday)
Vaccine on the way to S.A.
First doses could arrive as soon as Monday; inoculation may start next day
The beginning to the end of the pandemic that has killed nearly 300,000 Americans now is within sight.
The U.S. Food and Drug Administration approved Pfizer and BioNTech’s COVID-19 vaccine for emergency use Friday, clearing the way for UPS and FedEx to rush 2.9 million doses from Pfizer’s facility in Kalamazoo, Mich., to health care systems across the country.
Almost 225,000 doses will head to Texas, 28,275 of which are reserved for front-line health care workers in Bexar County, where the virus has killed more than 1,400 people.
“This is our hope and prayer,” said Dr. Robert Leverence, the chief medical officer for UT Health San Antonio, the city’s largest medical school. “This is really the first good news we’ve had.”
San Antonio’s first doses are expected to arrive as soon as Monday and will be divided among 10 hospitals and Wellness 360, the organization that provides health care to UT Health students, employees and their families.
Immunization could start the day after shipments arrive.
Texas is prioritizing vaccines for people most at risk of becoming exposed or dangerously ill with COVID-19 — such as EMS providers, health care workers and nursing home residents — because it could be months until the federal government secures enough supply for the general
public.
Later this month, the state is planning to launch a partnership program with Walgreens and CVS to provide free vaccinations to staff and residents in nursing homes and assisted-living facilities. Meanwhile, it also plans to send weekly shipments of vaccines to hospitals and health care systems.
“Our staff are very excited — they're rolling up their sleeves, and they're ready to come,” Leverence said. “This is history in the making.”
It usually takes years to develop vaccines, but scientists and drugmakers have been working at an unprecedented pace to develop vaccines to halt the spread of the coronavirus. The vaccine made by Pfizer and its German partner, BioNTech, emerged as the frontrunner, shattering speed records of vaccine development.
Several other vaccines are in the works, including one by U.S. biotech company Moderna, which could ask the FDA for emergency approval within the next week or two.
The federal government agreed this summer to buy 100 million doses from Pfizer at $19.50 per dose if the vaccine proved to be safe and effective.
Preliminary data has indicated it is: Earlier this week, a federal vaccine panel recommended the FDA allow the vaccine's emergency use in people 16 years or older.
It hasn't yet been tested with pregnant women or children.
The Pfizer vaccine must be given in two doses about three weeks apart. Trial data indicates it's 95 percent effective and might begin to protect people after the first dose. In comparison, flu shots are only 40 to 60 percent effective.
But getting the vaccine to the right place at the right time could be the greatest challenge yet.
The Pfizer vaccine must be shipped and stored at about minus 94 degrees Fahrenheit — more than 50 degrees colder than the average winter day at the North Pole.
“Once it's at room temperature, you've got a six-hour window” to administer the shot, said Elliot Mandell, the senior vice president and chief pharmacy officer of University Health. “We don't want to waste any product, and each vial of the vaccine contains five doses, so we have to ensure that our schedule is in multiples of five.”
Bexar County's public hospital system, University Health, is expected to receive 5,850 doses this week, which it will store in its own ultra-cold freezers. Thawing the vaccine takes about two to four hours in a refrigerator or 30 minutes at room temperature, Mandell said.
The state has told health care systems to administer all the doses in this first phase, promising it will send out another shipment to provide workers with the second booster shot.
Workers at the top of the list for the first doses are those at the highest risk of being exposed to COVID-19, such as staff in coronavirus units, emergency rooms, labor and delivery and urgent care.
Anyone who works in those settings, including nutrition and custodial staff, are considered first priority — not just nurses and doctors.
Mandell said University Health plans to vaccinate about 500 employees per day.
The process is expected to take longer than administering most vaccines because health care providers will observe people for 15 minutes after they get the shot, Mandell said.
“What would be a five-minute process turns into a 20-minute process for each person,” Mandell said. “Trying to remain socially distant in an observation space takes up quite a lot of space.”
So far, Pfizer has reported no serious side effects associated with the vaccine, which already has been approved by Britain, Canada, Bahrain and Saudi Arabia.
Britain became the first country to roll out the Pfizer vaccine early last week. Two people had allergic reactions — a rare but possible side effect of any drug — which spurred the nation's health officials to issue a warning that people with a history of anaphylaxis shock shouldn't take the vaccine until medical experts learn more about the incidents.
“The lesson learned there is, ‘Hey, if you had severe food allergies in the past or severe reaction to another vaccine, talk to your doctor,'” said Leverence of UT Health.
For the vast majority of people, the benefits far outweigh the risks, he said. Typically, the worst side effects people might experience are a day or two of achiness, fatigue, headache and, in some cases, fever — which also are known symptoms of COVID-19.
As San Antonio health care workers brace for what could be the city's worst surge of the pandemic yet, that complicates the push to vaccinate hospital staff as quickly as possible.
“If a health care worker has a fever, we'll have to send them home,” Leverence said. “The next question is, do we need to be worried this is COVID-19? And, maybe it was just a bad coincidence that they got COVID-19 simultaneously?”
UT Health plans to administer about 1,000 doses daily but only will inoculate up to 20 percent of a medical unit each day to maintain staffing levels if employees need to stay home for a day or two, Leverence said.
If employees' side effects last beyond the normal two-day period or include unusual symptoms like a cough or loss of taste or smell, they'll be encouraged to be tested for COVID-19.
Neither the Pfizer vaccine nor any of the others in development can cause COVID-19, Leverence said.
Unlike many other vaccines, these don't use a killed or weakened virus. Instead, synthetic messenger RNA — mRNA for short — direct cells to produce proteins that trigger the immune system to create antibodies, which fight the real virus if a person becomes infected.
Researchers have been studying mRNA vaccines for decades, but this will be the first time they'll be widely distributed.
Medical experts will continue to track the safety and effectiveness of the vaccine as it's administered in the U.S. and overseas.
“I can understand some initial hesitancy in this situation: Here we have what seems to be a very new technology — this mRNA vaccine — and we're pressed against time and sort of even rushing the process,” Leverence said. “But I have to say, the more I learn about the mRNA vaccine, the better I feel about the technology.”