MONDAY, April 12, 2021 (HealthDay News) -- People living with someone who has COVID-19 appear to get powerful protection against infection when they are given Regeneron's antibody cocktail, a new study shows.
The findings suggest that beyond preventing the worst outcomes for coronavirus infection when given early enough, the cocktail could also prevent people from getting sick in the first place, the company said Monday.
"With more than 60,000 Americans continuing to be diagnosed with COVID-19 every day, the REGEN-COV antibody cocktail may help provide immediate protection to unvaccinated people who are exposed to the virus, and we are also working to understand its potential to provide ongoing protection for immunocompromised patients who may not respond well to vaccines," Dr. George Yancopoulos, president and chief scientific officer at Regeneron, said in a statement.
In its statement, Regeneron said it would ask the U.S. Food and Drug Administration to expand the drug's emergency authorization use -- for high-risk people who already have COVID-19 but are not hospitalized -- to allow it to be given for preventive purposes in "appropriate populations."
There's "a very substantial number of people" in the United States and globally who could be a good fit to receive these drugs for preventive purposes, Dr. Myron Cohen, a University of North Carolina researcher told The New York Times. He leads monoclonal antibody efforts for the Covid Prevention Network, a U.S. National Institutes of Health-sponsored initiative that helped oversee the Regeneron trial.
"Not everyone's going to take a vaccine, no matter what we do, and not everyone's going to respond to a vaccine," Cohen noted.
The new data on Regeneron's antibody cocktail comes from a clinical trial that enrolled more than 1,500 people who lived in the same house as someone who had tested positive for the virus within the previous four days. Those who got an injection of Regeneron's drug were 81 percent less likely to get sick with COVID-19 compared to volunteers who got a placebo, the company said.
Dr. Rajesh Gandhi, an infectious diseases physician at Massachusetts General Hospital who was not involved in the study, told the Times that the data were "promising" for people who have not been vaccinated. But he noted that the type of patients that would be needed to determine whether the drug should be used preventively for immunocompromised patients were not included in the trial. "I would say we don't yet know that," Gandhi said.
Regeneron's cocktail, a combination of two drugs designed to mimic the antibodies generated naturally when the immune system fends off the virus, was given to President Donald Trump after he got sick with COVID-19 last fall.
The treatment received emergency authorization last November. Doctors are using it, as well as another antibody cocktail from Eli Lilly, for high-risk COVID-19 patients, to guard against severe disease and hospitalization.
But many hospitals and clinics have not made the treatments a priority because they are time-consuming and difficult to administer, mostly because they must be given via intravenously. Regeneron plans to ask the FDA to allow its drug to be given via an injection, as it was in the latest study, which would allow it to be given more quickly and easily.
J&J Covid Vaccine Supply to Drop 86% This Week
In a setback to a national vaccination campaign that was finally gaining ground, the federal government said last week that Johnson & Johnson will allocate 86 percent fewer doses of its coronavirus vaccine across the United States this week.
The company delivered the first batch of its single-dose vaccine at the beginning of March, sending 2.8 million doses across the country before dipping below 400,000 in the following weeks, the Times reported. Last week, about 1.9 million doses were sent across the country, and last week 4.9 million shots went out. This week, that number will drop to 700,000.
Federal administrators divide vaccine doses nationwide based on each state's adult population. That means that California will bear the brunt of the reduction: After receiving 572,700 doses of the vaccine last week, it will get only 67,600 doses of the J&J shot this week, the Times reported.
In Texas, the allocation will drop to 46,300 from 392,100. Florida, which received 313,200 shots last week, will get 37,000 this week, the newspaper said.
The slowdown comes days after federal officials learned that Emergent BioSolutions, a contract manufacturer that has been making both the Johnson & Johnson and the AstraZeneca vaccines in a Baltimore plant, had mixed up ingredients from the two and ruined up to 15 million doses of the Johnson & Johnson vaccine.
How big a role that problem has played in Johnson & Johnson distribution woes is hard to determine, the Times said.
Distribution hasn't been Johnson & Johnson's only problem: North Carolina health officials said last week that they stopped administering Johnson & Johnson vaccine doses at a mass immunization site in Raleigh and at clinics in Hillsborough and Chapel Hill after at least 26 people experienced adverse reactions, including fainting, the Associated Press reported. Four people were taken to hospitals for further examination, and state and federal health officials are reviewing the matter.
Kristen Nordlund, spokeswoman for the U.S. Centers for Disease Control and Prevention, told the AP that it is aware of adverse reactions in some people who received the vaccine shots in Iowa, Colorado, Georgia and North Carolina. Those reactions include dizziness, lightheadedness, feeling faint and rapid breathing.
Nordlund said the CDC is working with state and local officials to evaluate the problem and has performed vaccine lot analyses and found no cause for concern. The CDC is not telling health departments to stop vaccinations, the AP noted.
As for the nation's overall vaccination effort, the CDC reported Monday that just over 119 million Americans have received at least one dose of a vaccine, including about 72.6 million people who have been fully vaccinated.
COVID cases climb in Midwest as British variant takes hold
As new coronavirus cases soared across the Upper Midwest last week, a top health official said that a highly infectious variant first discovered in Britain has now become the most common source of infections in this country.
"Based on our most recent estimates from CDC surveillance, the B.1.1.7 variant is now the most common lineage circulating in the United States," CDC Director Dr. Rochelle Walensky said during a White House media briefing. There are now nearly 21,000 confirmed cases of the B.1.1.7 variant in the United States, according to the CDC.
Scientists and federal health officials have warned repeatedly that a fourth wave of coronavirus cases could arise in the United States this spring because of the emergence of more contagious variants and the easing of social distancing measures.
In the Upper Midwest, Michigan has been slammed: New cases and hospitalizations there have more than doubled in the last two weeks, and the six metro areas in the United States with the greatest number of new cases relative to their population are all in Michigan, the Times reported.
Several other states in the Upper Midwest have also reported significant increases in new infections and hospitalizations. In Illinois, the daily average for new cases has jumped about 56 percent in the past two weeks, to about 2,832 a day, the Times reported. Hospitalizations have risen about 28 percent from two weeks ago. Meanwhile, Wisconsin and North Dakota have seen their average case counts jump 50 percent or more in the last two weeks.
Nationally, new cases have stalled overall, while hospitalizations have leveled off and deaths remain near an average of about 800 a day, according to the Times.
The U.S. coronavirus case count passed 31.2 million on Monday, while the death toll passed 561,500, according to a Times tally. On Monday, the top five states for coronavirus infections were: California with more than 3.7 million cases; Texas with over 2.8 million cases; Florida with more than 2.1 million cases; New York with over 1.9 million cases; and Illinois with nearly 1.3 million cases. Worldwide, more than 136 million cases had been reported by Monday, with over 2.9 million dead from COVID-19.
The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.
SOURCES: The New York Times; Associated Press
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