Overnight Health Care: Coronavirus mutations give new urgency to vaccine race
Welcome to Friday’s Overnight Health Care. New COVID-19 variants have created a greater sense of urgency to get everyone vaccinated. Dr. Fauci says the variants are a wakeup call. And Johnson & Johnson has released data on its COVID-19 vaccine.
With new vaccines, US racing against coronavirus mutations
A new coronavirus vaccine from Johnson & Johnson appears to be another promising tool in the fight against COVID-19, but the U.S. is racing against problematic virus mutations that could throw a wrench into the system.
Johnson & Johnson on Friday announced its vaccine candidate offered strong protection against severe COVID-19 and prevented hospitalization and death, which could provide a major boost to the country’s overwhelmed health system.
The company is expected to file for emergency use authorization with the Food and Drug Administration (FDA) next week, potentially giving the U.S. a third vaccination to use against the virus.
Vaccine experts praised the results, and cautioned against comparing them head-to-head with the current Moderna and Pfizer vaccines already in use.
“The goal of this vaccine, it’s to keep you out of the hospital, keep you out of the ICU and keep you out of the morgue. Obviously it’s not fun having a mild infection, but it’s not a burden to the health care system,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
Read more here.
Speaking of mutations, Fauci notes they are a ‘wake up call’
During a White House coronavirus briefing, Fauci, the director of the National Institute of Allergy and Infectious Diseases, said that the different mutations have “clinical consequences” that will need to be addressed.
Recent studies from Johnson & Johnson and Novavax have shown some protection in their vaccines against variants, but the results are far weaker against the B.1.351 strain, which was first discovered in South Africa.
“This is a wake-up call to all of us,” Fauci said. “We will continue to see the evolution of mutants so we … will have to be nimble to be able to just adjust readily to make versions of the vaccine that actually are specifically directed towards whatever mutation is actually traveling at any given time.”
Centers for Disease Control and Prevention Director Rochelle Walensky said the country is working to quickly ramp up its genomic sequencing in order to better identify the differing variants.
However, she said the virus is so widespread that every new case should be treated as if it were a new variant.
More on Johnson & Johnson: 66 percent effective overall, but not against South Africa variant
A COVID-19 single-shot vaccine from Johnson & Johnson was 66 percent effective in preventing moderate or severe disease in a phase 3 clinical trial, a level of protection above the Food and Drug Administration’s (FDA) minimum but lower than the authorized Pfizer and Moderna vaccines.
There is also a warning sign from the variant found in South Africa. The efficacy dropped from 72 percent in the United States to 57 percent in South Africa, where a new coronavirus variant is prevalent.
That new variant has been more resistant to vaccines, including now this one, causing concern among experts. Still, a range of vaccines will likely provide protection against the variant.
The company plans to file for authorization from the FDA in “early February,” meaning the vaccine could soon add to the U.S. arsenal against the virus.
But, positive indications for staying out of the hospital at least: The company emphasized that its vaccine is 85 percent effective in preventing severe disease and was 100 percent effective in preventing hospitalization or death starting 28 days after vaccination. That is a crucial point, meaning that even if the vaccine is somewhat less effective in preventing people from getting sick at all, it still appears to protect well against people having to go to the hospital or dying.
How would the process of updating a vaccine work if needed? FDA says it would be ‘streamlined’
A top Food and Drug Administration (FDA) official said Friday that the agency will try to have a “streamlined” process for authorizing any updates that are required for COVID-19 vaccines to adapt to the threat of new variants.
“We would intend to try to be pretty nimble with this,” said Peter Marks, the head of the FDA center that reviews vaccines, during a webinar hosted by the American Medical Association.
Marks said the agency would work to “get these variants covered as quickly as possible.”
Experts have not yet said that updated vaccines are necessary, but they are monitoring the situation closely, particularly a variant first identified in South Africa that has been shown to diminish the effect of vaccines to varying extents.
Moderna, for example, said that while its studies have shown a reduced antibody response to the South African variant, its vaccines still appears to be protective, but “out of an abundance of caution” it is testing an updated vaccine specifically targeted against the new variant.
EU drug regulator clears AstraZeneca COVID-19 vaccine for all adults
The European Union’s drug regulator on Friday cleared AstraZeneca’s COVID-19 vaccine for all adults.
The European Medicines Agency recommended that the European Commission grant conditional marketing authorization for the vaccine, which was co-developed by the University of Oxford, for use in people aged 18 and older.
The vaccine is the third that the agency has recommended for approval; it previously recommended Pfizer and BioNTech’s vaccine, as well as a vaccine from Moderna.
“Today’s recommendation underscores the value of AstraZeneca’s COVID-19 vaccine which is not only effective and well-tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalizations,” AstraZeneca CEO Pascal Soriot said in a statement.
“We are deeply grateful to Oxford University, participants in the clinical trials and AstraZeneca colleagues for their unwavering commitment to providing this lifesaving vaccine to millions of Europeans,” he said.
Context: AstraZeneca has not yet asked for authorization in the U.S., where trials are still ongoing. But the EU’s approval is a good sign.
Read more here.
What we’re reading
J&J COVID vaccine is 66 percent effective, a weapon but not a knockout punch (STAT)
COVID-19 cases decline in nursing homes, offering hopeful sign for vaccines (The Wall Street Journal)
‘Long Covid’ still puzzles doctors but treatment is possible (CNN)
State by state
Vaccination chaos fuels push to recall Newsom (Kaiser Health News)
In search of COVID-19 vaccines, some rural Texans are driving hundreds of miles across the state (Texas Tribune)
Why Young, Healthy Researchers Are Being Vaccinated Before Seniors In Massachusetts (NPR)