Dr. Tal Zaks: Likely to be on the market by start of 2021

Moderna’s Israeli top medical officer: We’ve shown today that our vaccine works

US biotech firm’s shares soar as it claims tests of first volunteers show its vaccine candidate produces immune response, ‘has potential to prevent COVID-19’; Phase 3 tests in July

By TOI staff and Agencies 18 May 2020, 9:04 pm 7

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  In this March 16, 2020, file photo, a pharmacist gives Jennifer Haller, left, the first shot in the first-stage safety study clinical trial of a potential vaccine for COVID-19, the disease caused by the new coronavirus, at the Kaiser Permanente Washington Health Research Institute in Seattle. The vaccine by Cambridge, Massachusetts-based Moderna Inc., generated antibodies similar to those seen in people who have recovered from COVID-19 in a study volunteers who were given either a low or medium dose. (AP Photo/Ted S. Warren, File)
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  Moderna's Chief Medical Officer Dr. Tal Zaks. (Channel 12 screenshot)
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  A sign marks an entrance to a Moderna, Inc., building, Monday, May 18, 2020, in Cambridge, Mass. Moderna announced Monday, May 18, 2020, that an experimental vaccine against the coronavirus showed encouraging results in very early testing, triggering hoped-for immune responses in eight healthy, middle-aged volunteers.(AP Photo/Bill Sikes)

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The Israeli chief medical officer of US biotech firm Moderna said Monday that its experimental anti-COVID-19 vaccine “actually works,” after tests on a small number of volunteers, and that it will start Phase 3 testing on thousands of people in July.
“We got the first results today… and today we are showing that it actually works… we are able to stimulate the immune system,” Dr. Tal Zaks said.

In an interview with Israeli television, Zaks said he was confident that, toward the end of the year, “we’ll be able to present first results that prove that our vaccine indeed prevents the disease.”

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“By about the end of the year, the start of next year, there’s a reasonable likelihood that we’ll see this vaccine on the market, at least on the American market,” he said in the Channel 12 interview from Moderna’s headquarters in Massachusetts.

Moderna’s Chief Medical Officer Dr. Tal Zaks. (Channel 12 screenshot)

Zaks said the battle against COVID-19 marked the firm’s ninth bid to develop vaccines against viruses, “and we succeeded with the previous eight.” Thus, he said, “the degree of confidence within the company was always high” that it would succeed this time, too.
News of the company’s progress, revealed in a release earlier Monday, lifted shares of Moderna more than 22 percent, and helped drive the broader stock market higher.

A sign marks an entrance to a Moderna, Inc., building, on May 18, 2020, in Cambridge, Mass. Moderna announced May 18, 2020, that an experimental vaccine against the coronavirus showed encouraging results in very early testing, triggering hoped-for immune responses in eight healthy, middle-aged volunteers. (AP Photo/ Bill Sikes)

The 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.
At the lowest dose, Zaks elaborated in the TV interview, the vaccine candidate produced a similar response to that “naturally” produced by patients who recovered from the virus. At a medium dose, of 100 micrograms, he said, the vaccine candidate created “more antibodies” than those created naturally by recovered patients.

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.

A pharmacist gives Jennifer Haller, left, the first shot in the first-stage safety study clinical trial of a potential vaccine for COVID-19, the disease caused by the new coronavirus, at the Kaiser Permanente Washington Health Research Institute in Seattle, on March 16, 2020. The vaccine by Cambridge, Massachusetts-based Moderna Inc., generated antibodies similar to those seen in people who have recovered from COVID-19 in a study volunteers who were given either a low or medium dose. (AP Photo/Ted S. Warren, File)

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.

“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection,” Zaks stated in the firm’s official release. “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, 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 CEO 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.

“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.

President Donald Trump has said that 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 that 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.

Worldwide, about a dozen vaccine candidates are in the first stages of testing or nearing it. Health officials have said that if all goes well, studies of a potential vaccine might wrap up by very late this year or early next year.

More than 4.7 million infections and 315,000 deaths from the coronavirus have been confirmed worldwide since it emerged in China late last year. There are no specific approved treatments, although several are being used on an emergency basis after showing some promise in preliminary testing.