Name: Hundreds in Galveston getting COVID vaccine that appears effective
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Hundreds in Galveston getting COVID vaccine that appears effective

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The drugmaker Pfizer said Monday that its coronavirus vaccine appears highly effective based on preliminary data from its late-stage clinical trial, a rare hopeful development as the pandemic continues to surge in Texas, the nation and around the globe.The data, contained in a press release, suggested the company’s vaccine may be more than 90 percent effective at preventing symptomatic COVID-19, much more than was anticipated for any of the candidates in clinical trials. The Pfizer vaccine is the first to generate late-stage data.“Tentatively, this looks like good news,” said Peter Hotez, an infectious disease specialist at Baylor College of Medicine, which is testing another of the vaccines. “But it’s based on a press release, written for Pfizer shareholders, not scientists, and the company still has a ways to go — determining whether the vaccine halts severe disease and proves to be safe — before the FDA grants emergency approval. Still, it appears to be an important first step.”More from Todd AckermanThe press release was issued as Texas on Monday surpassed 1 million COVID-19 cases, more than any other U.S. state. El Paso and the Panhandle have led the Texas spike in cases, but Dallas and Harris counties have also contributed heavily in recent weeks. The virus has killed nearly a quarter of a million people in the U.S., including more than 19,000 in Texas.The University of Texas Medical Branch at Galveston is a participant in the global Pfizer trial, launched in late July. UTMB has enrolled more than 500 of the study’s nearly 44,000 participants at its three sites — Galveston, League City and Clear Lake.The data, the strongest sign yet that the race to develop COVID-19 vaccines will help bring the pandemic to an end, sent markets soaring Monday. The Dow spiked more than 1,600 points then gave back nearly half those gains to end the day up nearly 3 percent.President Donald Trump tweeted excitedly about both developments Monday: “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” Meanwhile, President-elect Joe Biden in a statement congratulated “the brilliant women and men who helped produce this breakthrough and give us such cause for hope” but cautioned it is “important to understand that the end of the battle against COVID-19 is still months away.”Pfizer’s plans called for the company to ask the Food and Drug Administration for emergency authorization after the third week of November, at which point the drug company will have two months of follow-up safety data on half of the participants in its trial. The company estimates it will have 50 million doses of its vaccine available globally by the end of 2020, enough to inoculate 25 million people with two doses each.When any vaccine receives approval, initial supplies will be allocated first to health care workers and others on the front lines, then to those in high-risk groups, such as nursing homes or seniors with serious, chronic conditions.On HoustonChronicle.com:UTMB, which has appointed a vaccine rollout task force, has already begun gearing up for FDA approval.“We’re excited, prepared to provide the vaccine, want to do it,” said Dr. Janak Patel, director of UTMB’s department of infection control and health care epidemiology. “We just hope lots of people will want to get it.”Delivery of the Pfizer vaccine will be limited by the need to keep it refrigerated at minus-94 degrees Fahrenheit until shortly before it is ready to be given. Very few nonacademic hospitals have such refrigerators.Experts cautioned about rejoicing too much over the news, noting the press release provided scant details besides the 90 percent efficacy finding, which could change as the trial goes on. They said there is far from conclusive evidence yet that the vaccine is safe and effective.But the experts also expressed elation at the 90 percent finding. Dr. Anthony Fauci, head of the federal government’s infectious disease agency, said 90 percent effectiveness is “just extraordinary.” He added that “not very many people expected it would be as high as that.”Over the summer, Fauci said he’d be happy with a vaccine that was 60 percent effective, and other scientists had warned that any COVID-19 vaccine may be only as protective as flu shots, which often work 50 percent of the time.The 90 percent finding is based on the first 94 cases of COVID-19 confirmed in trial participants, half of whom received the vaccine and half of whom received a placebo. The study didn’t provide a breakdown, but the vast majority infected had received the placebo.Most people in the study do not develop COVID-19 because they weren’t exposed to the virus.Study leaders will continue to track trial participants to determine if the 90 percent efficacy figure stands up as more cases of COVID-19 are identified in the pool.Because participants were tested only if they developed a symptom, the trial sheds no light on whether the vaccinated might include people who became infected, showed no symptoms and unknowingly spread the virus.No participant so far has become severely ill, Pfizer officials said. Side effects, similar to those reported in an earlier study, included pain at the injection site and fatigue, chills and fever.Among those happy to learn about the preliminary findings Monday was Esther Aviles, a League City schoolteacher who enrolled in the UTMB study and worried she could pass the virus to her students after her niece fell ill with the disease.“That’s really awesome,” said Aviles, an American-born daughter of Chilean immigrants who moved in with her sister after COVID-19 claimed her job in Denver. “It makes me feel good.”Aviles felt no side effects after getting the vaccine so she acknowledges she may have received the placebo. Under the trial protocol, trial participants who got the placebo will be among the first in line to receive the vaccine once the FDA approves it.Pfizer didn’t initially participate in Operation Warp Speed, the Trump administration’s initiative that helped fund and accelerate the work of a half-dozen vaccine efforts. Instead, Pfizer funded all of its work, at a cost of $2 billion, then struck a huge contract with the administration to produce 100 million doses if the vaccine is effective.Pfizer’s vaccine is one of 11 candidates in late-stage testing around the world, four of which are in the U.S. Moderna Inc., a U.S. company, said it hopes to be ready to file an application for its vaccine with the FDA based on data analysis expected to be revealed later this month, an official said Monday.Baylor was a participant in the Moderna vaccine trial, which is now closed. The leader of the Baylor arm said the Houston medical school enrolled 271 people in the trial.The University of Texas Health Science Center at Houston recently began enrolling participants in a third vaccine study, a candidate manufactured by AstraZeneca. That vaccine — developed by the University of Oxford and composed of a weakened and nonreplicating version of the chimpanzee adenovirus that causes the common cold — drew much attention early in the summer.todd.ackerman@chron.com

The drugmaker Pfizer said Monday that its coronavirus vaccine appears highly effective based on preliminary data from its late-stage clinical trial, a rare hopeful development as the pandemic continues to surge in Texas, the nation and around the globe.The data, contained in a press release, suggested the company’s vaccine may be more than 90 percent effective at preventing symptomatic COVID-19, much more than was anticipated for any of the candidates in clinical trials. The Pfizer vaccine is the first to generate late-stage data.“Tentatively, this looks like good news,” said Peter Hotez,...

Hundreds in Galveston getting COVID vaccine that appears effective

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