MODERNA Inc’s experimental vaccine was 94.5% effective in preventing COVID-19 based on interim data from a late-stage trial, the company has announced, becoming the second U.S. drugmaker to report results that far exceed expectations.
Together with Pfizer Inc’s vaccine, which is also more than 90% effective, and 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 this year.
Next year, the U.S. 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.
The vaccines, both developed with new technology known as messenger RNA (mRNA), represent powerful tools to fight a pandemic that has infected 54 million people worldwide and killed 1.3 million. The news also comes at a time when COVID-19 cases are soaring, hitting new records in the United States and pushing some European countries back into lockdowns.
“We are going to have a vaccine that can stop COVID-19,” Moderna President Stephen Hoge said in a telephone interview.
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.
“Having more than one source of an effective vaccine will increase the global supply and, with luck, help us all to get back to something like normal sometime in 2021,” said Eleanor Riley, professor of immunology and infectious disease at the University of Edinburgh.
Moderna expects to have enough safety data required for U.S. authorization in the next week or so and the company expects to file for emergency use authorization (EUA) in the coming weeks.
The company’s shares, which have more than quadrupled this year, rose 15% in premarket trading while European stocks and Wall Street stock futures jumped on the vaccine update. The benchmark S&P 500 futures rose 1.3%, stopping just short of a new record high, while the pan-European STOXX 600 hit late-February highs.
Shares in Pfizer were down 1.7% in premarket trading while Britain’s AstraZeneca, which has yet to release any results from its late-stage vaccine trials, were 0.7% weaker.
SEVERE CASES
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 normal fridge 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 -20C.
Pfizer’s vaccine must be shipped and stored at -70C, the sort of temperature typical of an Antarctic winter. It can be stored for up to five days at standard refrigerator temperatures or for up to 15 days in a thermal shipping box.
The data from Moderna’s trial involving 30,000 volunteers also showed the vaccine prevented cases of severe COVID-19, a question that still remains with the Pfizer vaccine. Of the 95 cases in Moderna’s trial, 11 were severe and all 11 occurred among volunteers who got the placebo.
Moderna, part of the U.S. government’s Operation Warp Speed program, expects to produce about 20 million doses for the United States this year, millions of which the company has already made and is ready to ship if it gets FDA authorization.
“Assuming we get an emergency use authorization, we’ll be ready to ship through Warp Speed almost in hours,” 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.
“We will need much more data and a full report or publication to see if the benefit is consistent across all groups, notably the elderly, but this is definitely encouraging progress, said Stephen Evans, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine.
One unknown with this vaccine, and all the others currently being tested, is whether they will stop COVID-19 spreading.
“It is likely that vaccines that prevent symptomatic disease will reduce the duration and level of infectiousness, and thus reduce transmission, but we don’t yet know if this effect will be large enough to make any meaningful difference to the spread of the virus within communities,” said Riley at Edinburgh University.
ROLLING REVIEW
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, Moderna said.
“These effects are what we would expect with a vaccine that is working and inducing a good immune response,” said Peter Openshaw, professor of experimental medicine at Imperial College London
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.
The United States has the world’s highest known number of COVID-19 cases and deaths with more than 11 million infections and nearly 250,000 deaths.
The Trump Administration has primarily relied on the development of vaccines and treatments as its response to the pandemic. Moderna has received nearly $1 billion in research and development funding from the U.S. government and has a $1.5 billion deal for 100 million doses. The U.S. government also has an option for another 400 million doses.
The company hopes to produce between 500 million and 1 billion doses in 2021, split between its U.S. and international manufacturing sites, dependent in part on demand.
Moderna also said it would use its data to seek authorization in Europe and other regions.
Europe’s health regulator said on Monday it had launched a real-time “rolling review” of Moderna’s vaccine, following similar reviews of vaccines from Pfizer and AstraZeneca.
Other countries such as China and Russia have already begun vaccinations. Russia licensed its Sputnik-V COVID-19 vaccine for domestic use in August before it released data from large-scale trials. It said on Nov. 11 that its vaccine was 92% effective based on 20 infections in its large trial.
Source – Thomson Reuters Foundation.
A facility set up by the World Health Organization (WHO) and the GAVI vaccine group has exceeded an interim target of raising more than $2 billion to buy and distribute COVID-19 shots for poorer countries but said it still needs more.
The GAVI alliance has announced that the funds for an advance market commitment (AMC) will allow the COVAX facility to buy an initial one billion vaccine doses for 92 eligible countries which would not otherwise be able to afford them.
“We’ve seen sovereign and private donors from across the world dig deep and meet this target and help ensure that every country will get access to COVID vaccines, not just the wealthy few,” GAVI chief Seth Berkley told reporters, adding that there was an “urgent need” to also finance treatments and diagnostics.
The European Commission, France, Spain, South Korea, the Bill & Melinda Gates Foundation and others had in recent weeks pledged another $360 million to the AMC, the alliance said, bringing total funding over the $2 billion target for this year.
Another $5 billion will be needed in 2021 to procure COVID-19 vaccine doses as they come through the development and are approved by regulators, GAVI said in a statement.
Berkley also welcomed the U.S. presidential election outcome, adding he expected to have talks with president-elect Joe Biden’s team about the COVAX plan.
“It’s positive that the incoming administration has already established a COVID-19 task force filled with many scientists we know are believers in science and moving this forward,” he said.
“The U.S. is already one of GAVI’s biggest supporters, they care enormously about vaccines for the developing world. And I suspect that we will have continuing conversations about how we can collaborate with them,” he added.
U.S. drugmaker Pfizer and its partner BioNTech , who this week said their experimental COVID-19 vaccine was 90% effective in initial trials, had expressed an interest in supplying doses to the COVAX facility, Berkley said.
“We continue to advance negotiations with a number of manufacturers in addition to those we’ve already announced who share our vision of fair and equitable distribution of vaccines,” he added. Berkley said $3 billion was also still needed for diagnostics and $6.1 billion for therapeutics by the end of 2021.
Source – Thomson Reuters Foundation.
PFIZER Inc’s experimental COVID-19 vaccine is more than 90% effective based on initial trial results, the drugmaker said, a major victory in the war against a virus that has killed over a million people and battered the world’s economy.
Experts welcomed the first successful interim data from a large-scale clinical test as a watershed moment that showed vaccines could help halt the pandemic, although mass roll-outs, which needs regulatory approval, will not happen this year.
Pfizer and German partner BioNTech SE said they had found no serious safety concerns yet and expected to seek U.S. authorization this month for emergency use of the vaccine, raising the chance of a regulatory decision as soon as December.
If granted, the companies estimate they can roll out up to 50 million doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
“Today is a great day for science and humanity,” said Pfizer Chief Executive Albert Bourla.
“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen,” he said.
Experts said they still wanted to see the full trial data, which have yet to be peer-reviewed or published in a medical journal, but the preliminary results looked encouraging.
“This news made me smile from ear to ear. It is a relief to see such positive results on this vaccine and bodes well for COVID-19 vaccines in general,” said Peter Horby, professor of emerging infectious diseases at the University of Oxford.
There are still many questions, such as how effective the vaccine is by ethnicity or age, and how long it will provide immunity, with the “new normal” of social distancing and face-covering set to remain for the foreseeable future.
Pfizer expects to seek U.S. emergency use authorization for people aged 16 to 85. To do so, it will need two months of safety data from about half the study’s 44,000 participants, which is expected in the third week of November.
U.S. Health and Human Services Secretary Alex Azar said it would take several weeks for U.S. regulators to receive and process data on the vaccine before the government could potentially approve it.
MARKETS SURGE
The prospect of a vaccine electrified world markets with the S&P 500 and Dow hitting record highs as shares of banks, oil companies and travel companies soared. Shares in companies that have thrived during lockdowns, such as conferencing platform Zoom Video and online retailers, tumbled.
Pfizer shares jumped more than 11% to their highest since July last year, while BioNTech’s stock hit a record high.
Shares of other vaccine developers in the final stage of testing also rose with Johnson & Johnson up 4% and Moderna Inc, whose vaccine uses similar technology as the Pfizer shot, up 8%. Britain’s AstraZeneca, however, fell 2%. Moderna is expected to report results from its large-scale trial later this month.
“The efficacy data are really impressive. This is better than most of us anticipated,” said William Schaffner, infectious diseases expert at Vanderbilt University School of Medicine in Nashville, Tennessee. “The study isn’t completed yet, but nonetheless the data look very solid.”
U.S. President Donald Trump welcomed the test results, and the market boost: “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” he tweeted.
President-elect Joe Biden said the news was excellent but did not change the fact that face masks, social distancing and other health measures would be needed well into next year.
The World Health Organization said the results were very positive but warned there was a funding gap of $4.5 billion that could slow access to tests, medicines and vaccines in low- and middle-income countries.
‘NEAR ECSTATIC’
“I’m near ecstatic,” Bill Gruber, one of Pfizer’s top vaccine scientists, said in an interview. “This is a great day for public health and for the potential to get us all out of the circumstances we’re now in.”
Between 55% and 65% of the population will need to be vaccinated to break the dynamic of the spread of COVID-19, said Germany’s health minister Jens Spahn, adding that he did not expect a shot to be available before the first quarter of 2021.
The European Union said on Monday it would soon sign a contract for up to 300 million doses of the Pfizer and BioNTech COVID-19 vaccine.
The companies have a $1.95 billion contract with the U.S. government to deliver 100 million vaccine doses beginning this year. They did not receive research funding from the Trump administration’s Operation Warp Speed vaccine program.
The drugmakers have also reached supply agreements with the United Kingdom, Canada and Japan.
Pfizer said the interim analysis, conducted after 94 participants in the trial developed COVID-19, examined how many had received the vaccine versus placebo.
Pfizer did not break down how many of those who fell ill-received the vaccine. Still, over 90% effectiveness implies that no more than 8 of the 94 had been given the vaccine, which was administered in two shots about three weeks apart.
The efficacy rate, which could drop once full results are available, is well above the 50% effectiveness required by the U.S. Food and Drug Administration for a coronavirus vaccine.
Shortly after Pfizer’s announcement, Russia said its Sputnik V vaccine was also more than 90% effective, based on data collated from inoculations of the public. Its preliminary Phase III trial data is due to be published this month.
MORE DATA NEEDED
To confirm the efficacy rate, Pfizer said it would continue its trial until there were 164 COVID-19 cases among volunteers. Bourla told CNBC on Monday that based on rising infection rates, the trial could be completed before the end of November.
Pfizer said its data would be peer-reviewed once it has resulted from the entire trial.
“These are interesting first signals, but again they are only communicated in press releases,” said Marylyn Addo, head of tropical medicine at the University Medical Center Hamburg-Eppendorf in Germany.
Dozens of drugmakers and research groups around the globe have been racing to develop vaccines against COVID-19, which on Sunday exceeded 50 million cases since the new coronavirus first emerged late last year in China.
The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks and produced at scale more rapidly than conventional vaccines. The technology is designed to trigger an immune response without using pathogens, such as actual virus particles.
The Trump administration has said it will have enough vaccine doses for all of the 330 million U.S. residents who want it by the middle of 2021.
Source – Thomson Reuters Foundation.
DRUGMAKERS and research centres around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway. Some companies had suggested early trial data could be ready for release in October, but have since pushed that back to November and December.
The following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over a million lives worldwide:
Who is furthest along? U.S. drugmaker Pfizer Inc with German partner BioNTech SE, and U.S. biotech Moderna Inc could have early data in November. Britain-based AstraZeneca Plc, in conjunction with the University of Oxford, and Johnson & Johnson say they are on track to deliver data for their vaccines this year.
What happens in these trials? The companies are testing their vaccines against a placebo – typically saline solution – in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot.
Why are data reports delayed beyond original predictions?
The trials rely on subjects becoming naturally infected with the coronavirus, so how long it takes to generate results largely depends on how pervasive the virus is where trials are being conducted. Each drugmaker has targeted a specific number of infections to trigger the first analysis of their data.
Pfizer, for instance, believes it may know if its vaccine works once 32 people contract COVID-19 in the 44,000-person trial, as long as the overwhelming majority of those infected had received the placebo.
But drugmakers have said an insufficient number of infections prior to the recent spikes in cases slowed their ability to present data earlier. Pfizer in October said it did not expect to have usable trial data until late November due to slow infection rates. It had previously suggested that would happen in October.
AstraZeneca said a slowdown in infections during the summer delayed its UK trial and that it expected to have results by the end of the year. Its timeline was also extended by a pause to investigate an illness in a UK trial participant.
After a slowing of infections in late summer and early autumn, COVID-19 cases were rampant again in October and early November, setting daily records in the United States and Europe as the weather cooled and people moved indoors. Experts have suggested that trial participants may also have been more careful to avoid contracting COVID-19 than the general population knowing they may have received a placebo.
How will we know if the vaccine works? The United States, the European Union, the United Kingdom and the World Health Organization have all set similar minimum standards for effectiveness. Some regulators have said that vaccines must demonstrate at least 50% efficacy – meaning at least twice as many infections among volunteers who got a placebo as among those in the vaccine group. The European Medicines Agency has said it may accept a lower efficacy level.
When will regulators decide? Regulators will review the vaccines after the companies have enough data to submit applications seeking emergency use authorization (EUA) or formal approval. The earliest they could decide is in December because Moderna and Pfizer/BioNtech do not expect to have enough safety data until the second half of November. U.S. regulators have asked that participants be watched for side effects for two months after receiving a final vaccine dose. AstraZeneca could provide a look at late-stage data by the end of the year. UK officials said there is a slight possibility they could decide on that vaccine in late December.
Regulators for Europe, the United Kingdom and Canada are considering data on a rolling basis, as it becomes available. They expect to do speedy reviews of initial data for possible emergency use before more traditional lengthy reviews for formal commercial approvals.
Could these be the first approved coronavirus vaccines? Yes, although China and Russia are on a similar timeline. China launched an emergency use program in July aimed at essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people. At least four vaccines are far along including from China National Biotec Group (CNBG), CanSino Biologics and Sinovac. Sinovac and CNBG have said to expect early trial data as soon as November. Russia’s Gamaleya Institute has begun a 40,000-person late-stage trial and is expected to have early data in November. Russia has also given the vaccine to at least hundreds of “high-risk” members of the general population.
Source – Thomson Reuters Foundation.