On the same day that President Donald J. Trump touted the therapeutics he received for his bout with Covid-19 as “miracles handed down by God” and specifically credited an antibody cocktail from Regeneron, the drug maker submitted a request for an emergency use authorization for its antibody cocktail, REGN-COV2, with the FDA. The therapeutic is a combination of two monoclonal antibodies (REGN1-933 and REGN10987) “and was designed to specifically block infectivity of SARS-CoV-2,” Regeneron wrote in a statement.
Regeneron noted that if the EUA is granted, it will make the experimental antibody combo available for free to more than 300,000 patients. The drug maker did not indicate if doses beyond that would be free.
The antibody cocktail is not without controversy, as it is derived from human fetal tissue. “The effectiveness of the antibody therapy was tested by employing a fetal tissue cell line from the 1980s widely used in biomedical research…,” according to the Washington Post. “The cell line is old enough that it would fall outside restrictions on federal funding of fetal tissue research the Trump administration imposed last year, according to National Institutes of Health guidelines.”
While Lawrence Goldstein, senior faculty member at the University of California San Diego, called Trump’s hawking of the therapeutic hypocritical, others are OK with it.
“’A lot of the opponents [of fetal tissue research] have looked the other way’ when it comes to the cell line involved in both the Regeneron therapy and some of the coronavirus vaccines being developed, said Goldstein, who sits on a federal ethics advisory board created over the summer to review whether NIH should give federal grants or contracts to proposals deemed deserving on scientific grounds. The board recommended rejecting all but one of the 14 proposals,” WaPo reports.
But David Prentice, who also sits on the same advisory board and is vice president and research director of the anti-abortion Charlotte Lozier Institute, is OK with Trump’s use of the experimental cocktail. Why?
“[B]ecause the fetal cell line was involved only in testing whether the antibody works in helping to defeat the virus, not in making the antibody itself,” WaPo reports. And, while he noted he’d prefer the cell line not be used, its use was only in testing and the cell line was not given to the recipient.
In September, Regeneron released trial data on the cocktail. “The greatest treatment benefit was in patients who had not mounted their own effective immune response, suggesting that REGN-COV2 could provide a therapeutic substitute for the naturally-occurring immune response. These patients were less likely to clear the virus on their own, and were at greater risk for prolonged symptoms,” George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron said in a statement.
Candace Hoffmann, Managing Editor, BreakingMED™
Cat ID: 190
Topic ID: 79,190,190,926,192,927,151,725,928,925,934
