Covid-19 roundup: Trump administration prepping exec order to reduce reliance on foreign manufacturing of 'essential medicines'
Back when President Trump was championing the potential of the malaria drug hydroxychloroquine, he convinced the Indian government to relax its export restrictions to supply the United States. Indeed, most generic therapies in the country are manufactured in India and China — and now, as the coronavirus pandemic puts this dependence in the spotlight, the Trump administration is reportedly working on making sure certain essential drugs are made at home.
According to a Bloomberg report, the administration is preparing an executive order to that effect.
“It is critical that we reduce our dependence on foreign manufacturers for essential medicines, medical countermeasures,” the nine-page draft said to “ensure sufficient and reliable long-term domestic manufacturing” in order to prevent shortages when needed. (Contamination concerns are, of course, another pertinent issue.)
The executive order, which is still in the draft stage, does not specify the list of “essential medicines,” but generally covers drugs and devices used to respond to a public health emergency or biohazard attack. The order limits federal contracts for supplies to US manufacturers and requires that production be divided among drugmakers to ensure price competition, the report said.
The order is under review at federal agencies including the Pentagon and the Department of Health and Human Services and has not been signed off on by the president, it added. — Natalie Grover
Accuracy of widely used Abbott test causes FDA concern
Test, test, test, the WHO urged nations months ago as the coronavirus crisis took on pandemic proportions. Testing, however, has been fraught with inaccuracies as scientists scrambled to get their tests on to markets swiftly, and regulators granted their blessings at an accelerated rate.
A rapid test from Abbott, promoted by the Trump administration as a key component to fight the US epidemic and is indeed used for daily testing in the White House, could be missing nearly half of positive cases, according to a recent study from researchers at New York University (although the data has not yet been peer-reviewed).
On Thursday, the FDA issued a statement cautioning the point-of-care test, which comes up with results in minutes, may return false-negative results.
“The FDA is sharing early information available about potential inaccurate results in the spirit of transparency,” the agency noted, adding that it had received 15 adverse event reports about the device that suggested some users are receiving inaccurate negative results.
After the NYU study data were unveiled, Abbott refuted the data in a series of tweets. The Abbott ID NOW test demonstrated 91% sensitivity and 100% specificity in a separate study conducted in Washington state, the company said on Wednesday on Twitter. — Natalie Grover
Our response to the New York University study:
The NYU study results are not consistent with other studies. (1/5) pic.twitter.com/hqY1Q5pkIR
— Abbott (@AbbottNews) May 13, 2020
Analysis of compassionate use data suggest convalescent plasma is safe for Covid-19
Late Thursday, a group of researchers supported by BARDA reported that data from 5,000 compassionate use cases confirmed the safety of this kind of treatment.
Until monoclonal antibodies against SARS-CoV-2 become widely available — and even the most advanced candidates are still making their way to the clinic — old-fashioned convalescent plasma remains the only antibody-based therapy available for Covid-19 patients. The idea of harvesting blood (and the myriad antibodies in it) from people who have recovered from a disease dates back decades, but the researchers noted in a preprint posted on medRxiv Thursday that it’s not yet been specifically shown to be safe in Covid-19.
“The data are reassuring,” Arturo Casadevall of Johns Hopkins University, a co-author, told the Wall Street Journal. “Now we can focus on finding out if it is effective.”
The patients analyzed here have severe or even life-threatening coronavirus infections, with 66% in the intensive care unit. Serious adverse events occurred in the first four hours after transfusion for less than 1% of the patients, including a mortality rate of 0.3%.
“However, only 2 (of 36) SAEs were judged as definitely related to the convalescent plasma transfusion by the treating physician,” they wrote. “The seven-day mortality rate was 14.9%.”
That number “does not appear excessive” given the deadly nature of Covid-19, they concluded. But it also can’t be construed as any indication as to the efficacy — as there was no control arm. — Amber Tong
With 5 vaccine candidates in Phase II, China hints there’s more to come next month
China expects to approve more vaccine candidates for human trials in June, adding to the current cohort of five, a government official said in a briefing on Friday.
Yixin Zeng, vice minister of the National Health Commission, noted that among the 2,000 people who have received experimental vaccines in Phase II trials, no serious side effects have yet been reported.
Backed in some cases by military and state and bolstered by accelerated regulatory timelines, the country boasts of more vaccines in development than any other. CanSino Biologics was among the first to launch clinical studies, racing other frontrunning efforts at Moderna and Oxford University, and has been in talks with researchers in Canada to conduct large-scale testing there as the pandemic comes under control in China. — Amber Tong
Dutch researchers exploring pharma deals for broadly neutralizing antibody candidate
After proposing a new neutralizing antibody against Covid-19 in Nature Communications earlier this month, researchers from Netherlands’ Utrecht University said they are in talks with major pharmaceutical manufacturers to develop the potential treatment.
“I think the most optimistic scenario is that we can reach the first patients in about six months,” said virologist and co-lead author Berend-Jan Bosch at a press conference, per Reuters.
The drug candidate, which appeared to neutralize both SARS-CoV-2 and the original SARS virus in vitro, was developed in partnership with Erasmus Medical Centre and Harbour Biomed. — Amber Tong
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