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Pfizer, the reputed leader in the COVID-19 vaccine race, may not have efficacy results for awhile. Meanwhile, AstraZeneca and Johnson & Johnson have resuming enrolling volunteers in the U.S. in their late-stage trials.
Matthew Herper of Stat is reporting today that Pfizer has not conducted an analysis of the COVID-19 vaccine that it is developing with BioNTech. Stat’s star reporter puts a good-news, bad-news spin on that development.
It could be good news because it means the vaccine hasn’t fallen short of the trial protocol’s proof of efficacy. The bad-news, glass-half-full take: The lack of analysis may mean that the trial will take longer than to yield answers about the vaccine’s efficacy than the company had hoped. In the COVID-19 vaccine race, Pfizer has been consistently touted as the frontrunner so the slower pace takes on added salience. As Herper explains, results from the trial may be emerging more slowly than predicted because there are not enough events — COVID-19 cases — occurring to establish a statistically valid difference between the vaccinated group and the control group. Pfizer had indicated in August that an interim analysis would be conducted in October, Herper reported.
CMS will make an announcement soon (later today or tomorrow) that Medicare and Medicaid beneficiaries won’t have any out-of-pocket costs related to getting a COVID-19 vaccine that has received an emergency use authorization, Politico reported yesterday.
The political news website said the announcement would come today or tomorrow.
One of the questions hanging over the COVID-19 candidates is how much protection might the vaccines provide to the groups of people who are most likely to suffer serious cases of the disease, such as the elderly. The immune system becomes less robust with age, so whether a vaccine will rev up a strong immune response is not a sure thing.
But on Monday, AstraZeneca said some early results from the trial of its vaccine, which is code named AZD 1222, show that it’s produced a strong immune response in older adults, according to several news outlets.
CNBC quoted an unnamed company official as saying that “it is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher.” Reactogenicity is the term for the fever, aches, and soreness at the injection site vaccines commonly produce.
Jonathan Ball, professor of virology at the University of Nottingham, told The Financial Times, which broke the story about the AstraZeneca trial, that the immunogenicity in older adults is a “promising sign,” but he cautioned that “ultimately, it’s whether the vaccine protects against serious disease that’s crucial and we will only know that from phase 3 trials.”
The Wall Street Journal reported the positive results included people age 70 and older.
The AstraZeneca vaccine was co-invented by researchers at the University of Oxford and a spin-off company of the university, Vaccitech.
Speaking of AstraZeneca, the British drugmaker restarted enrollment in its phase 3 trial in the U.S. on Friday, as did Johnson & Johnson. HHS Secretary Alex Azar hailed the resumption on Twitter on Friday. “It's worth repeating. These pauses show that the science- and data-driven process is working as it should," Azar added in a second tweet.
AstraZeneca paused its trial in September after a women in the United Kingdom developed neurological symptoms that some news reports identified as transverse myelitis, although that has never been fully confirmed.
Johnson & Johnson put out a statement Friday that said it was “preparing to resume recruitment” into the phase 3 trial of its vaccine. The company had paused the trial, dubbed ENSEMBLE, on Oct. 12 because a study volunteer developed what was described as an “unexplained illness.” In an interview with The New York Times last week, the company’s chief scientific officer, Paul Stoffels, M.D., said no one at the company knew whether the person had received the vaccine or the placebo.
The Cambridge, Massachusetts, biotech company announced on Thursday that the phase 3 trial of its COVID-19 trial had reached its enrollment goal of 30,000 and that more than 25,000 of the volunteers had received the second of the two-shot vaccinations. The company press releasee thanked PPD, a contract research organization headquartered in Wilmington, North Carolina, for the success. Moderna, which is calling its trail the COVE study, has some graphics on its website that show the diversity of the people have volunteered for the study. As of Oct. 21, 63% were White, 20% Hispanic/Latinx, and 10% Black. One of the slides show the enrollment of white volunteers far outnumbering the nonwhite white volunteers during the summer months and then, starting in late September, a switch to the nonwhite volunteers exceeding the number of white volunteers.
The Wall Street Journal reported yesterday that Egypt’s location, vaccine-making capacity and large population (100 million people) may make it proving ground and manufacturing center for COVID-19 vaccines in the developing world.
The newspaper reported that Chinese officials have talked about COVID-19 manufacturing in the North African nation. Importation of vaccines may also be in the works.
During last Thursday’s daylong meeting of FDA’s Vaccine and Related Biological Products Advisory Committee, Janell Routh, M.D., of the CDC talked up pharmacies as a distribution channel for COVID-19 vaccine(s).
Routh showed the advisory panel a map of the locations of the large chain pharmacies and independent drugstores, according to an account of the meeting by Forbes Senior Contributor Bruce Japsen.
“Pharmacies can help increase access to vaccines,” Routh said (according to Japsen). “Almost 90% of Americans live within a 10-mile radius of a pharmacy.”
A little over a week ago, on Oct. 16, HHS announced a partnership with Walgreens and CVS to administer COVID-19 to residents of long-term care facilities with no out-of-pocket costs to the residents.