New York: Moderna Inc and Pfizer Inc have launched two 30,000-subject trials of COVID-19 vaccines. These trials could clear the way for regulatory approval and widespread use by the end of this year. This information was given by representatives of the two companies, Tuesday. The trials, both announced Monday, are the first late-stage studies supported by the Donald Trump administration. It is an effort to speed development of measures against the novel coronavirus. These trials are adding to the hope that an effective COVID-19 vaccine will soon be found It will help in ending the pandemic.
Moderna stock rose nine per cent and Pfizer shares rose 1.6 per cent in afterhours trade.
Both vaccine candidates rely on a new technology that allows for faster development and manufacturing than traditional vaccine production methods. However the vaccine candidates do not have an extensive track record.
So-called mRNA, or synthetic messenger RNA (mRNA), teaches the immune system to recognise and neutralise the coronavirus by mimicking its surface.
Moderna, which has never brought a vaccine to market, has received nearly $1 billion from the US government. The US government is helping bankroll several vaccine candidates under its ‘Operation Warp Speed’ programme.
Pfizer has an agreement to sell vaccines for 50 million people to the US government for around $2 billion, if the vaccine is effective.
More than 150 coronavirus vaccine candidates are in various stages of development. Among them some two dozen prospects are already conducting human testing.
Johnson and Johnson is launching clinical trials in the US this week and could start a larger, late-stage trial as early as September. British drugmaker AstraZeneca said it will begin large-scale US trials this summer of its vaccine under development with Oxford University researchers.
“Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people. We need the vaccine,” National Institutes of Health (NIH) Director Francis Collins said in a release. In the release Moderna’s large Phase III trial was also announced.
Manufacturers are ramping up production while testing is underway in order to respond as soon as possible to virus. The coronavirus currently doesn’t look like abetting. The COVID-19 pandemic is still spreading rapidly around the world and has killed nearly 6,50,000. In the process it has also severely battered the economies of many countries.
Moderna could have tens of millions of doses ready when and if the vaccine is deemed safe and effective, Collins told reporters on a call.
Pfizer said that if the trial was successful, it could seek regulatory approval as soon as October. Then it can supply vaccines for 50 million patients, at two doses each, by the end of the year.
Pfizer aims for about 1.3 billion doses by the end of 2021, and Moderna has set a target of 500 million-1 billion doses a year, beginning 2021. This was stated by Moderna chief executive Stephane Bancel. The late-stage trials are designed to evaluate the safety of vaccines and determine if they can prevent symptomatic COVID-19.
Anthony Fauci, the top US infectious disease official, said a readout from the Moderna trial could come by November or even earlier. Fauci said he was ‘not particularly concerned’ about the vaccine’s safety after seeing data from earlier, smaller trials. He also said he had briefed President Donald Trump about the trial Monday at the Oval Office.