Moderna reports 94.5% efficacy, Israel to receive first doses early 2021

Israeli-born CMO to ‘Post’: ‘It’s a wonderful day’ * Netanyahu speaks to Putin about purchasing Sputnik V

Moderna's logo is reflected in a drop on a syringe needle in this illustration taken November 9, 2020 (photo credit: REUTERS/ DADO RUVIC)
Moderna's logo is reflected in a drop on a syringe needle in this illustration taken November 9, 2020
(photo credit: REUTERS/ DADO RUVIC)
The Israeli-born chief medical officer of Moderna, Inc. told The Jerusalem Post that he is feeling “awesome” on Monday, after his company reported its experimental vaccine was 94.5% effective in preventing COVID-19, based on interim data from a late-stage clinical trial.
“It’s a wonderful day. Beautiful data,” CMO Tal Zaks said.
Moderna, a relatively young American start-up, was the first company to enter clinical trials. Its announcement comes just one week after another American company. Pfizer Inc., released data that showed its similar mRNA vaccine to be more than 90% effective.
Pending more safety data and regulatory review, the United States could have two vaccines authorized for emergency use in December with as many as 60 million doses of vaccine available by the year’s end. Next year, the US government could have access to more than 1 billion doses just from the two vaccine makers, more than needed for the country’s 330 million residents.
For Israel, the announcement was also met with celebration; back in mid-June, Israel became one of the first countries to sign on to receive the company’s novel coronavirus vaccine, if successful.
The prime minister said at the time that “we want to get these vaccines quickly if they are developed and when they will be developed – it puts us in a very good place in the world.”
“My goal is to bring as many vaccines as possible, from as many sources as possible to as many citizens as possible – and as quickly as possible,” Netanyahu added on Monday, noting in a press conference that he had spoken with Russian President Vladimir Putin with the aim of bringing the Russian "Sputnik V" vaccine to Israel within a few months. He added that, "It won't happen tomorrow, but it also won't take years."
Health Minister Yuli Edelstein said that “the company’s announcement is excellent news for Israeli citizens. The Health Ministry’s activity in recent months has been proven effective and successful at locating, contracting and purchasing the leading vaccines on the market.”
Zaks told the Post that the company has not been public about the number of doses committed to Israel but that it will be “a good amount in terms of immunizing those who need it the most," though N12 showed that Israel would receive 2 million doses - enough to vaccinate a million citizens - at a cost of NIS 240 million. Zaks said the company is “working through the details” but expects to begin delivery to the Jewish state sometime in the beginning of next year and that Israel will be among the first in line.
He further said that over the summer that he had high hopes for the development of a vaccine to combat the coronavirus, despite his company never completing production of a similar vaccine.
Both the Moderna and Pfizer vaccines are built using new technology known as messenger RNA or mRNA.
Moderna’s interim analysis was based on 95 infections among trial participants who received either a placebo or the vaccine. Of those, only five infections occurred in those who received the vaccine, which is administered in two shots 28 days apart.
A key advantage of Moderna’s vaccine is that it does not need ultra-cold storage like Pfizer’s, making it easier to distribute. Moderna expects it to be stable at standard refrigerator temperatures of 2 to 8 degrees Celsius (36 to 48°F) for 30 days and it can be stored for up to 6 months at -20 degrees Celsius.
Pfizer's vaccine must be shipped and stored at minus 70 degrees Celsius, the sort of temperature typical of an Antarctic winter. At standard refrigerator temperatures, it can be stored for up to five days.
THE DATA from Moderna’s 30,000 participant-strong trial also showed the vaccine prevented cases of severe COVID-19, a question that still remains with the Pfizer vaccine. Of the 95 cases of infections in Moderna’s trial, 11 were severe and all 11 occurred among volunteers who got the placebo.
Moderna, part of the US government’s Operation Warp Speed program, expects to produce around 20 million doses of the vaccine for the US this year, millions of which the company has already made, and is ready to ship if it receives FDA authorization.
“Assuming we get an emergency use authorization, we’ll be ready to ship through Warp Speed almost in hours,” Moderna President Stephen Hoge said. “So, it could start being distributed instantly.”
The 95 cases of COVID-19 included several key groups who are at increased risk for severe disease, including 15 cases in adults aged 65 and older and 20 in participants from racially diverse groups.
Most side effects were mild to moderate. A significant proportion of volunteers, however, experienced more severe aches and pains after taking the second dose, including about 10% who had fatigue severe enough to interfere with daily activities while another 9% had severe body aches. Most of these complaints were generally short-lived, the company said.
Moderna’s data provide further validation of the promising but previously unproven mRNA platform, which turns the human body into a vaccine factory by coaxing cells to make certain virus proteins that the immune system sees as a threat and mounts a response against.
Moderna expects to have enough safety data required for US authorization in the next week or so and the company expects to file for emergency use authorization in the coming weeks.
Moderna has received nearly $1 billion in research and development funding from the US government and has a $1.5b. deal for 100 million doses. The US government also has an option for another 400 million doses.
The company hopes to have between 500 million and 1 billion doses in 2021, split between its US and international manufacturing sites and dependent, in part, on demand.
The US government has said COVID-19 vaccines will be provided free to Americans, whether they have health insurance, are uninsured or are covered by government health programs such as Medicare.
Moderna also said it will use its data to seek authorization in Europe and other regions.
CMO ZAKS was born and raised in Israel and completed his studies at Ben-Gurion University in Beersheba. When he became a physician, he moved to the States and worked as a doctor while completing his doctoral thesis. Then, he spent time at the American National Cancer Institute.
“Those were terrific three years, but I felt like I excelled more as a physician rather than a researcher,” Zaks said in a recent interview with Globes.
He recalled thinking about focusing more on applied research, only to later realize that “the translation of science into medicine happens in the industry.” That realization led him to Sanofi, a global biopharmaceutical company, where he was made senior vice-president and head of oncology.
“During my time at Sanofi, I kept examining new technologies that could have a real impact in the world of medicine,” Zaks told Globes. “When I encountered Moderna’s platform, which used RNA in order to create medicine and various vaccines, it was an offer that I couldn’t resist.”
“To Meirav, my wife, it seemed like an exaggerated risk. Leaving a vice-president position in a big company to work for a start-up? To me it made perfect sense, thanks to the technology and capability of translating potential into reality in such a short time.”
Now, Zaks said his expectation is becoming reality.
“With enough vaccines – and not just ours but others – there will be enough supply to immunize a significant amount of the population that indeed we will be able to get back to normal,” Zaks told the Post in a previous interview. “I think we should put an end to this pandemic as we now experience it and get back to life as quickly as possible.”
He added that he is “worried about this coming winter, but I think by next spring or summer we should all be in a much better place.”
When asked if he thought the Moderna vaccine would work long-term, Zaks said it is possible the virus will change and that one day the world might even have SARS-CoV-3, another iteration of the current pandemic. But he explained that when that happens, if Moderna’s vaccine technology is already proven to prevent the disease, it will be “relatively straightforward” to update the vaccine.
Rivka Abulafia-Lapid, a senior virology lecturer at the Hebrew University of Jerusalem, expressed concern about the long-term effects of mRNA vaccines on the body.
“We are looking at short-term safety issues – headache, fever, vomiting – but we cannot see what happens in the future – what we will see on the cellular level in a couple of years,” she said in a previous interview. “This is not something easy to predict.”
“Very pleased with positive news from Moderna, the world needs a portfolio of vaccines,” tweeted RDIF CEO Kirill Dmitriev, whose vaccine candidate last week reported 92% efficacy based on interim data. “Vaccines with 90% plus efficiency are very promising, can save lives and restore economic growth.”
For Zaks, success is personal. He said that his 80-year-old mother lives in Ra’anana, and he missed seeing her for Passover because of coronavirus.
“I want her to get vaccinated and the rest of us to get vaccinated so life can return to normal,” he said. “I take this responsibility deeply and personally.”
He also said he had a message to Israeli brothers and sisters: “Please be careful and stay safe for now. We still have a couple of winter months to get through and this is dangerous.
“Just be patient,” he continued, “I think there is a solution around the corner.”