Moderna says its vaccine is 94.5 per cent effective in preventing Covid-19

Vaccine hope as company says its shots provide strong protection

In this image courtesy of the Henry Ford Health System, volunteers are given the Moderna mRNA-1273 Coronavirus Efficacy (COVE), on August 5, 2020, in Detroit, Michigan. - The first COVID-19 vaccine trial volunteers in Michigan received their first shots Augus 5, in an effort to help find a safe, effective vaccine to the deadly coronavirus. “This is a historic moment,” said Dr. Marcus Zervos, Division Chief of Infectious Disease for Henry Ford Health System. “A vaccine is our best hope in the fight against COVID-19, and we’re glad to be a part of bringing this opportunity to the Midwest.” (Photo by - / Henry Ford Health System / AFP) / RESTRICTED TO EDITORIAL USE - MANDATORY CREDIT "AFP PHOTO / Henry Ford Health System" - NO MARKETING - NO ADVERTISING CAMPAIGNS - DISTRIBUTED AS A SERVICE TO CLIENTS

US biotech company Moderna gave new hope for an effective weapon against Covid-19 on Monday by announcing its experimental vaccine was 94.5 per cent effective in preventing the virus.

Moderna is the second US company to report results that far exceed expectations.

A week ago, competitor Pfizer announced its own Covid-19 vaccine appeared similarly effective – news that puts both companies on track to seek permission within weeks for emergency use in the US.

Moderna hailed its Covid-19 vaccine as a potential "game changer".

"We are going to have a vaccine that can stop Covid-19,” said Dr Stephen Hoge, Moderna’s president. He welcomed the “really important milestone” but said having similar results from two different companies is what is most reassuring.

“That should give us all hope that actually a vaccine is going to be able to stop this pandemic and hopefully get us back to our lives,” Dr Hoge said.

“It won’t be Moderna alone that solves this problem. It’s going to require many vaccines” to meet the global demand, he said.

Stéphane Bancel, Moderna's chief executive, said: “This is a pivotal moment in the development of our Covid-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent Covid-19 disease, including severe disease.”

Both the Pfizer and Moderna shots rely on a technology called messenger RNA that has never been used to build an approved vaccine. Soon, millions of people around the world could be spared from the illness by the breakthroughs.

A preliminary analysis of data from more than 30,000 volunteers showed Moderna’s vaccine prevented virtually all symptomatic cases of Covid-19, the disease caused by the coronavirus, the company said.

A key advantage of Moderna's vaccine is that it does not need ultra-cold storage like Pfizer's, making it easier to distribute.

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We have two vaccines that are really quite effective, so I think this is a really strong step forward

Moderna expects it to be stable at normal fridge temperatures of 2°C to 8°C for 30 days and it can be stored for up to six months at minus 20°C. Pfizer's vaccine must be shipped and stored at minus 70°C, 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.

Moderna, part of the US government's Operation Warp Speed programme, expects to produce about 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 authorisation.

"Assuming we get an emergency use authorisation, we'll be ready to ship through Warp Speed almost in hours," Dr Hoge said. "So it could start being distributed instantly."

The UK government has committed to buying 5 million vaccines, which is enough for 2.5 million people.

Hajj inspiration

Lebanese-American virologist Hadi Yassine played a pivotal role in the development of the vaccine.

He fell ill in 2013 after completing the hajj pilgrimage to Makkah.

FILE - In this July 27, 2020, file photo, nurse Kathe Olmstead prepares a shot that is part of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., in Binghamton, N.Y. Moderna said Monday, Nov. 16, 2020, its COVID-19 shot provides strong protection against the coronavirus that's surging in the U.S. and around the world. (AP Photo/Hans Pennink, File)

The breakneck speed at which the US team was able to roll out a vaccine candidate – the shot was given to the first volunteer during trials after just 63 days – is down to groundbreaking work that the US National Institutes of Health did in 2013 with Dr Yassine and the common coronavirus that returned with him from Makkah.

The team worked on Sars and Mers before turning their attention to other coronaviruses.

The work done by the NIH in 2013 through to 2017 has directly informed the progress that the institutes have made on pandemic preparedness in the run-up to the coronavirus outbreak.

Dr Yassine’s discovery has not only led to the lightning-fast roll-out of the Moderna vaccine trials but is also the science behind about half the other vaccine candidates now in the race to stop Covid-19.

Shares quadruple

Moderna's shares, which have more than quadrupled this year, rose 15 per cent 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 per cent, stopping just short of a new record high, while the pan-European STOXX 600 hit late-February highs.

"Just as their initial dose of vaccine bullishness appeared to be waning, the markets got another injection of good news this Monday," said Spreadex analyst Connor Campbell.

"One-upping BioNTech and Pfizer, Moderna has claimed its preparation is nearly '95 percent effective' after a trial involving 30,000 Americans.

"As with Pfizer, there is still a way to go before Moderna's vaccine is approved. However, investors were only thinking about the long term, flashing forward to the end of this nightmare."

World oil prices soared by more than 3.5 per cent as the Moderna news stoked hopes of a recovery in energy demand.

Only five participants who received two doses of the vaccine became ill, compared with 90 coronavirus cases in participants who received a placebo, according to a review by an independent data safety monitoring board appointed by the US National Institutes of Health.

The vaccine also appeared to be effective in preventing the most serious Covid-19 infections. There were no severe cases among people who got the vaccine, compared with 11 in volunteers who received placebo shots, according to Moderna.

Volunteers vaccinated

If the US Food and Drug Administration allows emergency use of Moderna’s or Pfizer’s candidates, there will be limited, rationed supplies before the end of the year. Both require people to get two shots, several weeks apart. Moderna expects to have about 20 million doses, earmarked for the US, by the end of 2020. Pfizer and its German partner BioNTech expect to have about 50 million doses globally by the year’s end.

Moderna’s vaccine, created with the National Institutes of Health, is being studied in 30,000 volunteers who received either the real vaccination or a placebo.

The study is continuing, and Moderna acknowledged the protection rate might change as more Covid-19 infections are detected and added to the calculations. Also, it is too soon to know how long protection lasts. Both cautions apply to Pfizer’s vaccine as well.

But Moderna’s independent monitors reported some additional, promising details: all 11 severe Covid-19 cases were among placebo recipients, and there were no significant safety concerns.

The main side effects were fatigue, muscle aches and injection-site pain after the vaccine’s second dose, at rates that Mr Hoge characterised as more common than with flu shots, but on par with others such as the shingles vaccine.

Andrew Hill, senior visiting research fellow in the department of pharmacology at the University of Liverpool, said: "This vaccine would be much easier to transport and administer than the one from Pfizer. Also the preliminary evidence suggests that it can prevent severe Covid-19 disease.

However, the Moderna vaccine is more expensive and there are fewer doses available in the next year. No vaccine company has enough supplies available to protect everyone in need. We will need all the available vaccines with over 90 per cent efficacy to cover global demand."

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said: "This announcement is a further encouragement that vaccines will be found to not only have an acceptable efficacy, but an efficacy that is much greater than we had anticipated.

"The range of minor adverse effects reported are unsurprising and typical of almost any vaccine. These reactions tend to be local to where the injection was given and are rarely long-lasting or severe.

"Although they reported efficacy being over 94 per cent, there is statistical uncertainty in this; but based on these data, the likely efficacy will be better than 85 per cent, which would be greater than most scientists would have expected."

Europe testing

The US’s top infectious disease expert said the news “is really quite impressive”.

Dr Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, said that Moderna’s finding, along with similar results from Pfizer last week, “is something that foretells an impact on this outbreak”.

“So now we have two vaccines that are really quite effective, so I think this is a really strong step forward to where we want to be about getting control with this outbreak,” Dr Fauci said.

Eleanor Riley, professor of immunology and infectious disease at the University of Edinburgh, said: "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."

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.

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