WASHINGTON - The head of the US Food and Drug Administration raised the possibility in an interview published Sunday that a future vaccine against the coronavirus might be given emergency approval before the end of trials designed to ensure its safety and effectiveness.
A request for such extraordinary approval would have to come from the vaccine developer, Stephen Hahn told the Financial Times.
"If they do that before the end of Phase Three," which involves large-scale human testing, "we may find that appropriate. We may find that inappropriate, we will make a determination.”
But Hahn insisted he was not acting under pressure from President Donald Trump, who has been pushing hard for a vaccine, saying one might be ready before US elections November 3.
"This is going to be a science, medicine, data decision," Hahn said. "This is not going to be a political decision."
Three Western drugs makers are well along with their Phase 3 clinical trials, involving tens of thousands of participants.
The three are AstraZeneca, which is partnering with Oxford University in England; Moderna, collaborating with the US National Institutes of Health, and the Pfizer/BioNTech alliance.
By the nature of the trials it is difficult to predict when reliable results will emerge.
Half of the participants in such trials receive an experimental vaccine, while the other half are given a placebo.
Under normal procedures, test administrators must wait -- probably for months -- to see whether there is a statistically significant difference in the infection rate of the two groups.
As the world desperately awaits an effective vaccine against the deadly virus, China and Russia have already approved vaccines without waiting for the conclusion of trials -- drawing criticism from public health officials in other countries, including the US.
Hahn also said that an emergency authorization would not necessarily cover everyone -- it might be granted for specific, high-risk groups.
"Our emergency use authorization is not the same as a full approval," he said.
Hahn has faced mounting criticism from the medical community that he has given in to political pressure from the Trump administration, largely involving two incidents.
In March, the FDA gave emergency authorization for the use of hydroxychloroquine to treat Covid-19 after Trump repeatedly praised its use; the authorization had to be withdrawn in June after serious side effects emerged.
More recently, Hahn delivered a far too optimistic appraisal, during a news conference with Trump, of the effectiveness of convalescent plasma against the virus. He said it could save 35 out of 100 patients; the more likely number, experts said, is five in 100.
"It is f-ing outrageous to expedite *any* approval of a #SARSCoV2 vaccine, irrespective of @SteveFDA's subservience to Trump," Eric Topol, director of the Scripps Research Translational Institute, said on Twitter.
"We will not know about safety for many months."
Agence France-Presse
PARIS - Biomérieux, a French healthcare company specializing in diagnostics, said on Monday it had won more positive feedback from the US Food and Drug Administration (FDA) regulator for its product aimed at helping test for the coronavirus.
BioMerieux said its 'BIOFIRE® RP2.1' panel testing product, which includes 22 pathogens that cause respiratory infections including SARS-CoV-2 which causes the COVID-19 coronavirus, had won 'emergency use authorization' from the FDA.
While the 'BIOFIRE® RP2.1' test has not had full clearance or approval from the FDA, the decision to give the product 'emergency use authorization' nevertheless marks more progress.
BioMérieux said it was looking to scale up supply of the BIOFIRE® RP2.1 panel at its production facilities in Salt Lake City (Utah, USA).
Test kits will be available for commercial distribution in the USA under the emergency use authorization, as well as internationally where regulatory approval allows.
BioMérieux added it expected to steadily build inventory levels to address the needs of the thousands of labs and healthcare professionals given an expected rise in demand for products aimed at testing for the presence of the coronavirus.
-reuters-
GlaxoSmithKline on Tuesday said it was recalling the popular heartburn medicine Zantac in all markets as a "precaution", days after the US Food and Drug Administration found "unacceptable" levels of probable cancer-causing impurity in the drug.
Zantac, also sold generically as ranitidine, is the latest drug in which cancer-causing impurities have been found. Regulators have been recalling some blood pressure and heart failure medicines since last year.
Britain's medicines watchdog said GlaxoSmithKline (GSK) was recalling four prescription-only Zantac medicines: a syrup, an injection and tablets of 150 and 300 milligram (mg) dosages.
Over-the-counter 75 mg dosage Zantac products are produced by a different company and are not affected by the recall, it added.
"GSK informed the MHRA of our decision to suspend the release, distribution and supply of all dose forms of Zantac products," a company spokesman confirmed to Reuters.
"GSK is continuing with investigations into the potential source of the NDMA," he said, adding that the investigations include continued engagement with its suppliers and with external laboratories to conduct tests on finished product batches of Zantac.
The Medicines and Healthcare products Regulatory Agency (MHRA) said healthcare professionals were told on Monday to "stop supplying the products immediately, quarantine all remaining stock and return it to their supplier".
"We are advising that patients should not to stop taking their medication, and do not need to see their doctor until their next routine appointment but should seek their doctor's advice if they have any concerns," the MHRA said.
GLOBAL STOPPAGE
US and European health regulators said last month they were reviewing the safety of ranitidine, after online pharmacy Valisure flagged the impurities.
The FDA said Valisure's higher-temperature testing method generated very high levels of NDMA from the ranitidine drugs.
NDMA had previously been found in some blood pressure medicines from a class of drugs known as angiotensin II receptor blockers, or ARBs.
After checking the over-the-counter drugs using a low-heat method of testing, the FDA said it found much lower levels of NDMA than was discovered with a higher temperature test employed by Valisure.
The US regulator has asked ranitidine makers to conduct their own testing to assess levels of the impurity and to send samples of their products for testing by the agency.
Swiss drugmaker Novartis halted global distribution of its ranitidine drugs last month.
Last week, Walmart Inc joined pharmacy chains CVS Health Corp, Walgreens Boots Alliance Inc and Rite Aid Corp in suspending the sale of over-the-counter heartburn drugs containing ranitidine.
Canada's health authorities have asked makers of the drugs to halt distribution as they gather more information. Last month, regulators in Hong Kong pulled four products, while in Ireland 13 products containing ranitidine were recalled.
The impurity was believed to have been introduced by changes in the manufacturing process.
source: news.abs-cbn.com
