A US drug maker Moderna has announced its most successful drug candidate has showed signs of induced immune responses in the early stage human trials conducted on volunteers age between 18 ad 55.
The interim result, the Massachusetss-based biotech giant announced on Monday, show the antibodies in the vaccine Mrna-1273 were at similar levels to people who recovered from Covid-19.
“When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent Covid-19 disease and advance our ability to select a dose for pivotal trials,” Moderna’s chief medical officer Tal Zaks said.
The company is expected to start the second phase of the trial soon and the final-stage experiments in July. America’s National Institute of Allergy and Infectious Diseases (NIAID) led the first phase.
“These interim phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg (micrograms),” Zaks said.
The success of phase 3 trials, including the finalization process, will make Moderna, the first company to carry out and announce human trials, eligible to apply for a regulatory license for commercial use of its vaccine.
It would be able to produce “a limited vaccine by fall of 2020”.
“With today’s positive interim phase-one data, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal phase-three study in July and, if successful, file a BLA (biologics license application),” said Stéphane Bancel, the company’s chief executive officer.
The US Food and Drug Administration licenses such product in the US.
“We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2 (Covid-19),” Bancel added.
Meanwhile, President Donald Trump will soon announce a $354 million contract for new Virginia company Phlow to manufacture COVID-19 medicines.