US drugmaker reports promising early results from COVID-19 vaccine test
In this file photo a view of Moderna headquarters is seen on May 8, 2020 in Cambridge, Massachusetts. US biotech firm Moderna on May 18, 2020 reported "positive interim" results in the first clinical tests of its vaccine against the new coronavirus performed on a small number of volunteers. The vaccine appeared to produce an immune response in eight people who received it, of the same amplitude as that observed in people infected with the virus, the company said, adding that phase 3 trials with a large number of volunteers would begin in July.
AFP/MADDIE MEYER/GETTY IMAGES NORTH AMERICA
US drugmaker reports promising early results from COVID-19 vaccine test
Ivan Couronne (Agence France-Presse) - May 19, 2020 - 7:37am

WASHINGTON, United States — US biotech firm Moderna reported promising early results on Monday from the first clinical tests of an experimental vaccine against the novel coronavirus performed on a small number of volunteers.

The Cambridge, Massachusetts-based company said the vaccine candidate, mRNA-1273, appeared to produce an immune response in eight people who received it similar to that seen in people convalescing from the virus.

"These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection," said Moderna's chief medical officer Tal Zaks.

"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," Zaks said.

President Donald Trump welcomed the news saying "it's incredible what they can do and I've seen results.

"And the results are staggeringly good," Trump told reporters. "So I'm very happy and the market's up very big."

Wall Street stocks posted substantial gains on Monday with the Dow Jones Industrial Average adding 3.85 percent and the S&P 500 up 3.15 percent.

Moderna shares gained 19.96 percent to close at $80.00 in New York.

Moderna, which was founded nine years ago, said the vaccine "was generally safe and well tolerated" and that patients suffered no more than redness or soreness from the shots.

In a conference call, Moderna chief executive Stephane Bancel said the preliminary tests inspired confidence that mRNA-1273 has "a high probability to provide protection" against the virus.

"We could not be happier about these interim data," Bancel said of the Phase 1 test, the first of three in the development of a vaccine. 

Separate tests performed on mice showed that the vaccine prevented the virus from replicating in their lungs, according to the company.

The US government has invested nearly half a billion dollars in the development of Moderna's vaccine candidate.

It is being developed in a partnership with the National Institute of Allergy and Infectious Disease headed by Anthony Fauci and the clinical test was carried out by the National Institutes of Health.

'As fast as safely possible'

Three groups of 15 patients aged 18 to 55 received three different doses of the vaccine in the Phase 1 test, the complete results of which are not yet known.

The Phase 2 trial, with 600 subjects, has already received the green light from the US Food and Drug Administration and Moderna said they should begin this quarter.

A Phase 3 trial, the largest and most important to validate the efficacy of a vaccine, should begin in July.

"The Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July," said Bancel, Moderna's CEO.

Based on the Phase 1 partial results, Moderna said they would no longer study the highest dose since the lower doses appeared to provide some effect.

"The lower the dose, the more people we expect to be able to protect," said Moderna president Stephen Hoge.

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said that while it was difficult to be sure of the results "from a press release," there was reason for optimism.

"It must be noted that this is a Phase 1 study which has an object of showing the vaccine is able to induce an antibody response and that the dose range is appropriate," Evans said.

"It will not be until the Phase 3 trial is completed that it will be known whether the vaccine actually prevents COVID-19 disease," he added.

Trump has said he wants 300 million vaccine doses by January 2021 to protect the US population and his administration has provided funding to Moderna, Johnson & Johnson, and France's Sanofi.

The development of a vaccine usually takes years but the coronavirus pandemic, which has caused more than 315,000 deaths, has given unprecedented urgency to the search.

A dozen clinical trials are taking place around the world, half of them in China, according to the London School of Hygiene & Tropical Medicine.

China has said that it is carrying out tests on humans of five experimental vaccines.

The challenge is not only finding a safe and efficient vaccine but also producing billions of doses.

Several large laboratories, including Moderna, have said they would immediately begin production of an eventual vaccine even before the completion of all of the clinical trials.

Moderna recently announced a partnership with the giant drugmaker Lonza to boost its manufacturing capacity to up to one billion doses a year.

NOVEL CORONAVIRUS VACCINE
As It Happens
LATEST UPDATE: August 13, 2020 - 4:08pm

Follow this page for updates on a mysterious pneumonia outbreak that has struck dozens of people in China.

August 13, 2020 - 4:08pm

The Department of Health logs 4,002 new cases of the coronavirus, bringing the national caseload to 147,526.

There are 1,403 new recoveries and 23 new deaths,

August 13, 2020 - 2:09pm

New Zealand rushed to track the source of a sudden return of the coronavirus Thursday as the number of new cases in its biggest city rose to 17 and officials warned more infections were inevitable.

National health chief Ashley Bloomfield said there were 13 new confirmed infections in Auckland, all linked to four family members found on Tuesday, ending the country's record of 102 days without community transmission.

The surge in new cases raised the prospect that a three-day lockdown imposed in Auckland since midday Wednesday would be extended as teams of health workers hunted for the cluster's origin and ramped up testing in the city. — AFP

August 13, 2020 - 10:07am

New Zealand health officials say a COVID-19 cluster in Auckland had grown, raising the prospect a lockdown imposed on the country's biggest city after the virus returned will be extended.

National health director-general Ashley Bloomfield says a high school student in Auckland had tested positive, taking the number of confirmed infections to five, with another four probable cases.

"This is someone who was a close contact with one of our existing confirmed cases," Bloomfield tells TVNZ. — AFP

August 13, 2020 - 7:54am

The novel coronavirus has killed at least 743,199 people since the outbreak emerged in China last December, according to a tally from official sources compiled by AFP at 1100 GMT on Wednesday.

At least 20,382,260 cases have been registered in 196 countries and territories. Of these, at least 12,347,300 are now considered recovered.

The tallies, using data collected by AFP from national authorities and information from the World Health Organization (WHO), probably reflect only a fraction of the actual number of infections. — AFP

August 12, 2020 - 4:09pm

The Department of Health confirms 4,444 additional cases of the coronavirus disease. The Philippines now has a total of 143,749 COVID-19 infections.

636 more patients have recovered while 93 died from the deadly virus.

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