Early-Stage Data Of Chinese Vaccine Looks Promising, But Experts Warn Method Has Failed In Past
The testing strategy in use involves using a modified virus to carry genetic instructions to a human cell. The method isn't among the most successful in terms of vaccine development. Meanwhile, former FDA Commissioner Scott Gottlieb predicts the United States will have a better vaccine sooner than China.
The New York Times:
Coronavirus Vaccine Shows Promising Early Results In China
A vaccine developed in China appears to be safe and may protect people from the new coronavirus, researchers reported on Friday. The early-stage trial, published in the Lancet, was conducted by researchers at several laboratories and included 108 participants aged 18 to 60. Those who received a single dose of the vaccine produced certain immune cells, called T cells, within two weeks. Antibodies needed for immunity peaked at 28 days after the inoculation. (Mandavilli, 5/22)
Stat:
Early Study Of Covid-19 Vaccine Developed In China Sees Mixed Results
Data on the vaccine, made by CanSino Biologics, were published Friday in the Lancet, the first time Phase 1 trial data from any Covid-19 vaccine have been published in a scientific journal. The results are likely to be closely examined, particularly in Canada, which recently announced it would test the vaccine and produce it there if results of the early studies were positive. The study found that one dose of the vaccine, tested at three different levels, appeared to induce a good immune response in some subjects. But about half of the volunteers — people who already had immunity to the backbone of the vaccine — had a dampened immune response. (Branswell, 5/22)
Politico:
U.S. Is Ahead Of China In Vaccine Race, Former FDA Chief Says
The United States will have a "better" vaccine than China — and it will have it sooner, former Food and Drug Administration Commissioner Scott Gottlieb predicted Sunday. Data on the potential vaccines in clinical development in China "didn't look overwhelmingly strong," Gottlieb told Margaret Brennan on CBS' "Face the Nation." "Those vaccines, if they do work, probably are going to provide lower levels of immunity than the platforms that the U.S. and Europeans are working with," he said. "So I think we're going to have a better vaccine, and I think we're probably going to have it sooner based on where we are in clinical development, some of the early progress that we've shown." (Mueller, 5/24)
In other vaccine news —
Stat:
FDA’s Woodcock To Stop Drug Approval Work To Focus On Covid-19 Vaccines
Food and Drug Administration stalwart Janet Woodcock will temporarily step aside as the director of the agency’s Center for Drug Evaluation and Research to work solely on a White House initiative meant to accelerate Covid-19 treatments, Commissioner Stephen Hahn announced Friday in an agency-wide email obtained by STAT. The news is monumental for the FDA: Woodcock has served as the permanent director of CDER for more than a decade, since 2008. She joined the FDA in 1986 and is widely considered the most experienced regulator at the agency. (Florko, 5/22)
Stat:
He Had A Severe Reaction To Moderna Covid-19 Vaccine. He's Still A Believer
Patients in clinical trials are usually faceless. But as the experimental Covid-19 vaccine being developed by Moderna Therapeutics has begun advancing through studies, it has found a much more visible advocate: trial volunteer Ian Haydon, a 29-year-old in Seattle. Haydon has spoken about the vaccine on CNN and CNBC. He even said he’d volunteer to be exposed to the novel coronavirus, SARS-CoV-2, if researchers want to test to see if the vaccine was actually effective. But up until now he has left out a key detail: He is, apparently, one of three people in the trial who had a systemic adverse reaction to the vaccine. (Herper, 5/26)
Stat:
WHO Warns Millions Of Children At Risk As Pandemic Disrupts Vaccinations
Some 80 million babies around the world are at higher risk of diseases like diphtheria, measles, and polio as the coronavirus pandemic hinders routine vaccination programs, global health officials warned Friday. Vaccine campaigns have been disrupted in at least 68 countries, according to data released by the World Health Organization, UNICEF, the Sabin Vaccine Institute, and Gavi, the Vaccine Alliance. The interruptions could affect 80 million children under 1 year old in those countries. (Joseph, 5/22)
