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LOCA^NATION The Times, Gainesville, Georgia | gainesvilletimes.com Friday, December 11,2020 3A US panel endorses widespread use of Pfizer vaccine MARK LENNIHAN I Associated Press A pharmacist labels syringes in a clean room where doses of COVID-19 vaccines will be handled, Wednesday, Dec. 9, at Mount Sinai Queens hospital in New York. BY LAURAN NEERGAARD AND MATTHEW PERRONE Associated Press WASHINGTON - A U S. gov ernment advisory panel endorsed widespread use of Pfizer’s coro- navirus vaccine Thursday, put ting the country just one step away from launching an epic vaccina tion campaign against the outbreak that has killed close to 300,000 Americans. Shots could begin within days, depending on how quickly the Food and Drug Administration signs off, as expected, on the expert committee’s recommendation. In a 17-4 vote with one absten tion, the government advisers concluded that the vaccine from Pfizer and its German partner BioNTech appears safe and effec tive for emergency use in adults and teenagers 16 and over. That endorsement came despite questions about allergic reactions in two people who received the vaccine earlier this week when Britain became the first country to begin dispensing the Pfizer-BioN- Tech shot. While there are a number of remaining unknowns about the vaccine, in an emergency, “the question is whether you know enough” to press ahead, said panel member Dr. Paul Offit of Chil dren’s Hospital of Philadelphia. He concluded that the potential benefits outweigh the risks. The decision came as COVID-19 cases surge to ever-higher levels across the U.S., with deaths set ting an all-time, one-day record of more than 3,100 on Wednesday. Pfizer has said it will have about 25 million doses of the two-shot vaccine for the U.S. by the end of December. But the initial supplies will be reserved primarily for health care workers and nursing home res idents, with other vulnerable groups next in line until ramped-up produc tion enables shots to become widely available on demand — something that will probably not happen until the spring. Next week, the FDA will review a second vaccine, from Moderna and the National Institutes of Health, that appears about as pro tective as Pfizer-BioNTech’s shot. A third candidate, from Johnson & Johnson, which would require just one dose, is working its way through the pipeline. Behind that is a candidate from AstraZeneca and Oxford University. U.S. health experts are hoping a combination of vaccines will ulti mately enable the U.S. to conquer the outbreak. Still, experts estimate at least 70% of the U.S. population will have to be vaccinated to achieve herd immunity, the point at which the virus can be held in check. That means it could be several months before things start to get back to normal and Americans can put away their masks. All eyes now turn to the FDA staff scientists who will make the final decision of whether to press ahead with large-scale immuniza tions with Pfizer-BioNTech’s vac cine. FDA’s vaccine director Dr. Peter Marks said a decision would come within “days to a week.” Dr. William Moss of Johns Hopkins University, who was not involved in the expert panel’s review, welcomed the outcome, saying, “Given how bad the pan demic is now, we need to move.” The independent review by non government experts in vaccine development, infectious diseases and medical statistics was consid ered critical to boosting Ameri cans’ confidence in the safety of the shot, which was developed at breakneck speed less than a year after the virus was identified. Regulators not only in Brit ain but in Canada have already approved the vaccine for use in their countries, and President Donald Trump and White House officials have complained for weeks that the FDA was moving too slowly. FDA scientists issued a glow ing review of the vaccine earlier in the week. Agency staffers said data from Pfizer’s ongoing study of 44,000 people showed strong protection across different age groups, races and health condi tions with no major, unexpected safety problems. The Pfizer-BioNTech shot remains experimental because that final-stage study isn’t com plete. As a result, the expert panel wrestled with a list of questions that have yet to be answered. For example, while the vac cine is more than 90% effective in blocking the symptoms of COVID- 19, the FDA’s advisers stressed it is not yet clear whether it can stop the silent, symptomless spread that accounts for up to half of all cases. “Even though the individual effi cacy of this vaccine is very, very, very high, you really as of right now do not have any evidence” that it will lower transmission, said Dr. Patrick Moore of the Univer sity of Pittsburgh. He urged Pfizer to take additional steps to answer that question. Several of the dissenting panel members objected to authorizing the shot for 16- and 17-year-olds, given their small numbers in the study and the low risk they face from COVID-19. Members worried, too, that Pfizer will lose its opportunity to answer critical questions once it begins offering the real vaccine to study participants who had been getting dummy shots up to now. The company proposed gradu ally moving those patients to the vaccine group, with priority based on age, health conditions and other factors. Under that plan, 70-year- old participants would cross over before healthy 30-year-olds. Pfizer must still show whether the vaccine works in children younger than 16 and in pregnant women. On the safety front, as wide spread vaccinations begin, the first recipients will be closely tracked by government health authorities, since studies in tens of thousands of people can’t detect side effects that strike 1 in a million. Hanging over the meeting were the British allergic reactions and a warning from authorities there that people with a history of serious reactions shouldn’t get the vaccine for now. Pfizer representatives said they have seen no signs of allergic reactions in their trial. But some of the FDA advisers fear the Brit ish warning will deter millions of Americans with allergies who might benefit from the COVID-19 vaccine from giving it a try, and urged additional studies to try to settle the issue. COVID-19 ■ Continued from 1A Department of Public Health. NGHS has recorded 464 deaths across its facili ties in the region, with six coming from Wednesday into Thursday. The U.S. recorded 3,124 deaths Wednesday, the highest one-day total yet, according to Johns Hopkins University. Up until last week, the peak was 2,603 deaths on April 15, when New York City was the epi center of the nation’s out break. The latest number is subject to revision up or down. Wednesday’s national death toll eclipsed Ameri can deaths on the opening day of the Normandy inva sion during World War II: 2,500, out of some 4,400 allied dead. And it topped the toll on Sept. 11, 2001: 2,977. Locally, the Northeast Georgia Health System continues to see record high numbers of COVID- 19 patients at its facilities. Thursday, Dec. 10, was the second consecutive record- breaking day this week, with 221 COVID-19 patients. As a further illustration of the rising peaks, cots are being set up in a gym on the campus of Northeast Georgia Medical Center in Gainesville, and the system expects that overflow space to open some time next week. New cases per day are running at all-time highs of over 209,000 on average. And the number of people in the hospital with COVID- 19 is setting records nearly every day. A U.S. government advi sory panel convened on Thursday and endorsed mass use of Pfizer’s COVID- 19 vaccine to help conquer the outbreak. Depending on how fast the FDA signs off on the panel’s recommen dation, shots could begin within days, inaugurating the biggest vaccination campaign in U.S. history. In St. Louis, respiratory therapist Joe Kowalczyk said he has seen entire floors of his hospital fill up with COVID-19 patients, some of them two to a room. He said the supply of ven tilators is dwindling, and the inventory is so thin that colleagues on one shift had to ventilate one patient by using a BiPAP machine, similar to the devices used to treat sleep apnea. When he goes home to sleep during the day at the end of his grueling over night shifts, he sometimes has nightmares. “I would be sleeping and I would be working in a unit and things would go com pletely wrong and I would shock myself awake. They would be very visceral and very vivid,” he said. “It would just really spook me. ” In South Dakota, Dr. Clay Smith has treated hundreds of COVID-19 patients while working at Monument Health Spearfish Hospital and at Sheridan Memorial Hospital in neighboring Wyoming. He said patients are becoming stranded in the emergency room for hours while they await beds on the main floor or transfers to larger hospitals. And those transfers are becom ing more challenging, with some patients sent as far away as Denver, 400 miles from the two hospitals. “That is a huge burden for families and EMS sys tems as well when you take an ambulance and send it 400 miles one way, that ambulance is out of the community for essentially a whole day,” he said. Smith added that some patients have gone from thinking “I thought this was a hoax” to “Wow, this is real and I feel terrible.” But he has also seen people with COVID-19 who “continue to be disbelievers. It is hard to see that.” “At the end of the day the virus doesn’t care whether you believe in it or not,” he said. In New Orleans, city Health Director Dr. Jen nifer Avegno described a recent visit to a hospital where she watched doc tors, nurses, respiratory therapists and others risk exposure to the disease in a long, futile attempt to save a dying COVID-19 patient. Some broke down in tears afterward, she said. “These are seasoned emergency and critical care personnel,” she said. “We do not cry very often — and especially not a num ber of us all at once.” She cited “the sheer exhaustion of giving their all for similar patients over and over and over again for the past nine months, coupled with the knowledge that much of this could be prevented with really sim ple measures.” In Virginia, Gov. Ralph Northam, a doctor by train ing, announced a midnight curfew and expanded mask rules to require the wearing of face coverings outdoors, not just inside. In New York City, which was ravaged by the virus in the spring, one doctor sounded a note of relative optimism, saying that at least physicians are more capable of managing the virus now. “Early in the spring we did not know enough,” said Dr. Jolion McGreevy, who directs Mount Sinai Hos pital’s emergency depart ment. “We really are operating from a place of knowledge, now — which is a big leap from where we were in the spring.” AP National Writer Jocelyn Noveck in New York contributed to this report. Associated Press journalists from around the globe contributed to this report. Earthquake reported in Northeast Forsyth County Forsyth County News According to the US Geological Ser vice, a 1.8 magnitude earthquake was recorded in Northeast Forsyth County at about 8:45 p.m. Dec. 9. In a Facebook post on Thursday night, Forsyth County Sheriff Ron Freeman stated that “dozens of calls” were made to 911 as the quake was felt in Forsyth County, but no damage was reported. Freeman’s post stated that the quake occurred at a depth of 5 kilometers. There were no impacts in Hall County, said Casey Ramsey, the coun ty’s Emergency Management Agency director. This article originally appeared in the Forsyth County News, a sister publication of The Times.
