Hopes for an early arrival for treatment or vaccine for the dreaded Coronavirus were heightened yesterday after news from both the US and German that progress was being made in test trials for an anti-Covid-19 medication.
In New York Wall Street was given the cheering news that remdesivir, the drug being developed by Gilead Sciences is likely to get some form of accelerated approval or expanded use after a pair of company statements said the drug worked in Covid-19 patients, Wall Street analysts said who expect an approval very soon.
Gilead’s stock rose 3.2%, paring a more than 7% gain. A Food and Drug Administration official further bolstered those expectations, saying the agency is talking with Gilead about getting the drug to patients and making it available as appropriate.
Later yesterday, it emerged that a German company working with US pharmaceutical giant Pfizer had begun human trials of a potential Covid-19 vaccine that could supply millions by the end of the year. Pfizer said it will begin testing the experimental vaccine in the United States as early as next week, and says a vaccine could be ready for emergency use in the last quarter of this year, the Wall Street Journal reported.
Mainz-based BioNTech reported that the first cohort of participants had been given doses of the potential vaccine, BNT162, in a Phase 1/2 clinical study in Germany.
“Twelve study participants have been vaccinated with the vaccine candidate BNT162 in Germany since the start of the study on April 23, 2020,” the company said in a statement.
No information on the results is currently available. BioNTech said around 200 healthy volunteers aged 18 to 55 years old would be given doses ranging from 1µg (microgram) to 100µg to find the optimal dose for further studies.
“In addition, the safety and immunogenicity of the vaccine will be investigated,” added the biotech company.
Pfizer and BioNTech plan to initiate trials for BNT162 in the US on regulatory approval, expected shortly, the statement said.
The German Federal Institute for Vaccines and Biomedical Drugs approved the trial — the country’s first clinical trial for a vaccine against Covid 19 — on April 22.
However, some analysts are urging cation regarding Gilead’s promise.
“Patients treated within 10 days of symptom onset did better and observed clinical improvements appear positive in both arms, though we need to see proper natural history to better understand magnitude of effect.”
“Regardless, we view the 7% mortality rate observed in the trial outside of Italy positively based on natural history we have collected.”
Regulators are likely combing through the data now, and “remdesivir could receive approval – at least in severe patients – very soon.”
For the study from the National Institute of Allergy and Infectious Diseases (NIAID), the analyst said he was waiting on the full details “to be able to assess the magnitude of benefit,” as well as more results from a second ongoing Gilead-sponsored study in moderate patients expected next month.
“Any clinical benefit for remdesivir with an acceptable safety profile could leave it well positioned for potential FDA approval.”
