AstraZeneca paused global trials due to an adverse event last month in the United Kingdom. The U.K. trial resumed shortly after, but the U.S. trial remained on hold.
The decision means there continues to be multiple late-stage vaccine candidates with results expected in the next several months. It is unclear how the long pause affects AstraZeneca's trial timeline and integrity.
J&J paused recently after being advised by an independent monitoring board after a serious event.
“Based on the information gathered to date and the input of independent experts, the company has found no evidence that the vaccine candidate caused the event,” J&J said in the statement.
A vaccine is much-needed as the U.S. set a worrying new record for daily coronavirus cases Thursday, surpassing 77,000 in a single day, according to several reports, which differs slightly from Johns Hopkins data, which has been keeping a worldwide tally since the crisis began.
The new record breaks a summer high of 75,000 daily cases — raising alarm among health care officials bracing for surges in rural areas, where the virus is taking the biggest toll. In addition, the states most affected has been rearranged, with Texas overtaking California for the state with the most cases, even though the Lone Star State has tested less aggressively.
The global case count is nearing 42 million, with more than 1.1 million dead, while in the U.S. the total case count has exceeded 8.4 million and more than 223,000 deaths have been reported.
In an effort to remove limitations and the designation as investigational drug for Gilead Science’s (GILD) remdesivir, marketed as Veklury, the U.S. Food and Drug Administration (FDA) gave its full approval for the drug Thursday. While it marks the first branded drug to receive full approval, it doesn’t change much for the health care community, which has already been relying on it and dexamethasone as treatments for COVID-19.
Northwell Health’s Feinstein Institutes for Medical Research in New York recently touted Roche’s (RHHBY) rheumatoid arthritis drug, Actemra, combined with a corticosteroid like dexamethasone, as another potential treatment.
For remdesivir, the review is mixed, with some experts saying the jury is still out.
Dr. Dara Kass, Yahoo medical contributor, said the news is not that important for patient care.
“It does not change mortality; it’s not saving lives. It’s just reducing hospitalizations,” Kass told Yahoo Finance Friday.
President Donald Trump claimed the country is weeks away from widespread distribution of a vaccine at the final presidential debate Thursday night — specifically pointing to J&J, Moderna (MRNA) and Pfizer (PFE). At best, many experts say the country is weeks away from knowing if one vaccine candidate, the one created by Pfizer and BioNTech (BNTX) is effective, while Moderna’s results are due in December and J&J’s trial remains on hold.
“No, we’re not close to a vaccine just yet,” Kass said Friday, noting that no vaccine will be ready for widespread distribution soon.
Trump touted the involvement of the U.S. Department of Defense, but the DOD has not been involved with manufacturing Pfizer’s candidate — the likely first to receive emergency use authorization— and others are further away. Aside from distribution of the vaccine to the general public, for which supplies are likely to be ready later in 2021, it is unclear what role the DOD would play.
Pfizer outlined its distribution plan in an earnings call earlier this month, including plans for ultra-cold packaging and storing. Its plan aligns with the discussions from the FDA’s vaccine advisory committee, which, in a much-anticipated meeting Thursday, declared the burden rests on manufacturers to ensure handling, delivery, and storage — as well as the integrity of the vaccine to ensure that it is not compromised through expiry.
In defense of Fauci
Trump walked back harsh criticism of his top infectious disease expert, National Institute of Allergy and Infectious Disease Director Dr. Anthony Fauci, at the debate Thursday night.
After recently calling him and other scientists “idiots,” Trump said he had a great relationship with Fauci, but that mistakes have been made in how to handle the pandemic. Both Fauci and U.S. Surgeon General Jerome Adams were among top federal experts advising against mask-wearing. That was prior to studies showing that masks could help protect against the virus, both have recently said.
Still, the scientific community recently wrote in support of Fauci, in a letter to a trade publication.
“Fauci is a giant of epidemiology, one of the world’s most respected scientists in infectious diseases, and an American hero who has served multiple administrations—both Republican and Democrat—for decades,” the authors wrote.
“When a public servant of Fauci’s caliber is attacked, it puts our collective efforts, and the safety of the American public, at risk.”
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