Moderna Inc’s vaccine against Covid-19 may be ready for widespread use later this year, company and United States officials said Monday, after the drug maker announced the start of a trial of 30,000 subjects. To demonstrate that it is safe and effective, the final hurdle before regulatory approval.
The trial is the first such late-stage study under the Trump administration’s program to accelerate the development of measures against the new coronavirus, adding to hopes that an effective vaccine will help end the pandemic. Moderna’s shares rose 7.5%.
Moderna, which has never brought a vaccine to market, has received nearly $ 1 billion from the United States government, which is helping to fund several vaccine candidates under its Operation Warp Speed program.
More than 150 candidates for the coronavirus vaccine are at various stages of development, with about two dozen prospects already conducting tests on humans.
Pfizer Inc and Johnson & Johnson will launch advanced-stage clinical trials this month for their Covid-19 vaccine candidates. British pharmacist AstraZeneca Plc said it will begin large-scale trials in the United States this summer of its developing vaccine with researchers from the University of Oxford.
“Having a safe and effective vaccine distributed by the end of 2020 is a difficult goal, but it is the right goal for the American people,” said director of the National Institute of Health (NIH), Francis Collins, in a statement announcing the start. of the great phase of Moderna. III trial.
Manufacturers are increasing production while testing to respond as quickly as possible to the virus, which is still rapidly spreading worldwide. Covid-19 has killed nearly 650,000 people worldwide and has hit economies.
Moderna could have tens of millions of doses ready when and if the vaccine is deemed safe and effective, Collins told reporters in a call.
The company is still on track to deliver around 500 million doses a year, and possibly up to a billion doses a year, as of 2021, Moderna CEO Stephane Bancel said in the call.
The large late-stage trial is designed to assess the safety of Moderna’s mRNA-1273 vaccine and determine whether it can prevent symptomatic Covid-19 after two doses.
Anthony Fauci, the top infectious disease official in the United States, said a trial reading could come in November or even earlier. Fauci said he was “not particularly concerned” about the safety of the vaccine after looking at data from earlier smaller trials.
The test volunteers will receive two separate injections about 28 days, either 100 micrograms of mRNA-1273 or a placebo.
The results of a small early-stage study published earlier this month showed that volunteers who received two doses of the Moderna vaccine had levels of antibodies to the virus that were above the average observed in people who had recovered from Covid-19.
Moderna’s candidate vaccine uses synthetic messenger RNA (mRNA) to mimic the surface of the coronavirus and teach the immune system to recognize and neutralize it. The technology enables faster development and manufacturing than traditional vaccines.
The Covid-19 Prevention Network, a United States government-funded program formed by the NIH, said it plans to launch a large-scale clinical trial of a Covid-19 vaccine candidate with at least 30,000 participants each month until fall.
The trial is the first such late-stage study under the Trump administration’s program to accelerate the development of measures against the new coronavirus, adding to hopes that an effective vaccine will help end the pandemic. Moderna’s shares rose 7.5%.
Moderna, which has never brought a vaccine to market, has received nearly $ 1 billion from the United States government, which is helping to fund several vaccine candidates under its Operation Warp Speed program.
More than 150 candidates for the coronavirus vaccine are at various stages of development, with about two dozen prospects already conducting tests on humans.
Pfizer Inc and Johnson & Johnson will launch advanced-stage clinical trials this month for their Covid-19 vaccine candidates. British pharmacist AstraZeneca Plc said it will begin large-scale trials in the United States this summer of its developing vaccine with researchers from the University of Oxford.
“Having a safe and effective vaccine distributed by the end of 2020 is a difficult goal, but it is the right goal for the American people,” said director of the National Institute of Health (NIH), Francis Collins, in a statement announcing the start. of the great phase of Moderna. III trial.
Manufacturers are increasing production while testing to respond as quickly as possible to the virus, which is still rapidly spreading worldwide. Covid-19 has killed nearly 650,000 people worldwide and has hit economies.
Moderna could have tens of millions of doses ready when and if the vaccine is deemed safe and effective, Collins told reporters in a call.
The company is still on track to deliver around 500 million doses a year, and possibly up to a billion doses a year, as of 2021, Moderna CEO Stephane Bancel said in the call.
The large late-stage trial is designed to assess the safety of Moderna’s mRNA-1273 vaccine and determine whether it can prevent symptomatic Covid-19 after two doses.
Anthony Fauci, the top infectious disease official in the United States, said a trial reading could come in November or even earlier. Fauci said he was “not particularly concerned” about the safety of the vaccine after looking at data from earlier smaller trials.
The test volunteers will receive two separate injections about 28 days, either 100 micrograms of mRNA-1273 or a placebo.
The results of a small early-stage study published earlier this month showed that volunteers who received two doses of the Moderna vaccine had levels of antibodies to the virus that were above the average observed in people who had recovered from Covid-19.
Moderna’s candidate vaccine uses synthetic messenger RNA (mRNA) to mimic the surface of the coronavirus and teach the immune system to recognize and neutralize it. The technology enables faster development and manufacturing than traditional vaccines.
The Covid-19 Prevention Network, a United States government-funded program formed by the NIH, said it plans to launch a large-scale clinical trial of a Covid-19 vaccine candidate with at least 30,000 participants each month until fall.
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