Japan’s Shionogi readies COVID-19 vaccine for December trial: CEO

By Rocky Swift

TOKYO (Reuters) – Shionogi & Co is planning clinical trials by year-end for what may be one of Japan’s first domestically produced COVID-19 vaccines to reach the market, as the globe races to secure enough doses to battle the pandemic.

The company plans to put its vaccine candidate into Phase 1 clinical trials in December and shift into Phase 2 by January and apply for tentative approval from the government, Shionogi chief executive Isao Teshirogi told Reuters in an interview.

But a Phase 3 trial would likely be done overseas due to the relative lack of COVID-19 cases in Japan, he said.

Shionogi’s plan to have enough doses to inoculate 30 million people by the end of next year means its impact will be much larger than that of first mover Osaka-based AnGes Inc, which expects to have its first doses ready by March.

“For almost national security reasons, having good capacity in Japan makes a lot of sense,” Teshirogi said.

While Shionogi lags global front runners that are now conducting mass final-stage clinical trials, it is betting on a proven platform to help it become Japan’s biggest home-grown COVID-19 vaccine producer. French drugmaker Sanofi SA and Novavax are using a similar process in their COVID-19 candidate.

“I think our recombinant protein vaccine, method wise, has more accumulated data on efficacy and safety than the novel methods,” Teshirogi said.

Newer methodologies like mRNA vaccines may end up being the solution, “but as of today, we don’t know anything”, he said.

Prime Minister Yoshihide Suga has pledged to provide enough vaccine for the populace by mid-2021, and Japan has struck deals for hundreds of millions of doses with companies including AstraZeneca Plc and Pfizer Inc.

Shionogi has received about $400 million from the Japanese government for its COVID-19 vaccine research.

But the world will need several different vaccines to fight the pandemic, given the sheer size of global demand, effects on different populations, and possible limits of effectiveness in the first vaccines.

Teshirogi said holding the postponed Tokyo Summer Olympics in 2021 is “still possible”, but it will depend more on high-rapid-diagnostic testing and logistics than vaccines.

“Receiving the vaccine is not a so-called safe license,” he said.

(Reporting by Rocky Swift in Tokyo; Editing by Miyoung Kim and Michael Perry)

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Fauci says findings will be known by early December

(Photo by Alex Edelman-Pool/Getty Images)

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LONDON — Hopes are rising that a Covid-19 vaccine could be approved by the end of the year, with drugmakers and research centers scrambling to help bring an end to the pandemic.

Dozens of candidate vaccines are in clinical evaluation, according to the World Health Organization, with some already conducting late-stage tests before seeking formal approval.

The outcome of the trials is being closely monitored around the world.

The U.S.’s leading expert on infectious disease believes it will only be a matter of weeks before the findings of a potential vaccine will be known.

“We will know whether a vaccine is safe and effective by the end of November, the beginning of December,” White House coronavirus advisor Dr. Anthony Fauci said in a BBC interview on Sunday.

“The question is: Once you have a safe and effective vaccine, or more than one, how can you get it to the people who need it as quickly as possible?”

Fauci said a vaccine deemed safe and effective would be rolled out according to a set prioritization, with individuals such as health care workers and those in a higher risk category likely to receive the first doses. He said it would be “several months into 2021” before a vaccine becomes more widely available.

The development of a vaccine, Fauci warned, would not replace the need for public health measures to help protect people from the disease for some time.

To date, more than 43 million people have contracted the coronavirus worldwide, with 1.15 million related deaths, according to data compiled by Johns Hopkins University.

Vaccine race

The race for a Covid vaccine has seen governments step in to try to help the process along by providing funds to allow companies to scale up manufacturing even before drugs have been approved.

Leo Varadkar, Ireland’s deputy prime minister, has said he is hopeful an inoculation against the coronavirus could be approved before the end of the year.

“I’m increasingly optimistic, as is government, that we will see a vaccine approved in the next couple of months and that in the first half or first quarter of next year it’ll be possible to start vaccinating those most at risk,” Varadkar, who is a qualified doctor, told RTE radio on Sunday.

A Rehab Support worker checks on patient notes as the first patients are admitted to the NHS Seacole Centre at Headley Court, Surrey, a disused military hospital, which has been converted during the coronavirus pandemic.

Victoria Jones | PA Images via Getty Images

Not all public health experts share the same level of optimism about the development of a Covid vaccine before year-end, however.

The Mail on Sunday reported plans had been drawn up for frontline National Health Service staff to receive a coronavirus vaccine within weeks, citing an email sent by an NHS Trust chief to his staff.

In response to the report, U.K. Health Minister Matt Hancock said on Monday that

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Fauci says findings on a potential coronavirus vaccine are expected by early December

Dr. Anthony Fauci

“We will know whether a vaccine is safe and effective by the end of November, beginning of December,” the director of the US National Institute of Allergy and Infectious Diseases said. “The amount of doses that will be available in December will not certainly be enough to vaccinate everybody — you’ll have to wait several months into 2021.”

Speaking to the BBC’s Andrew Marr Show, Fauci added that the vaccination of a “substantial proportion of the population” so there could be a “significant impact on the dynamics of the outbreak” may not be possible until the second or third quarter of 2021.

Pence adviser Marty Obst tests positive for coronavirus

“What I do foresee is that with a successful vaccine and the continuation of some form of public health measures, as we go and progress through the months of 2021, getting towards the third and fourth quarter, we will see a considerable approach towards some form of normality,” Fauci told Marr.

Pressed on whether he believes US President Donald Trump is correct in saying that the United States is “rounding the corner” in the course of the pandemic, Fauci said he believes this is untrue.

“The data speak for themselves,” Fauci said.

“Unfortunately, I am sorry to see what I’m viewing from a distance, what I’m seeing in the UK … after getting hit pretty badly the way we did, you went down to a pretty low level, but now you’re starting to escalate in the same manner that we are here,” he added.

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Moderna Says COVID-19 Vaccine Could Be Ready As Soon As December With FDA Approval

KEY POINTS

  • Moderna CEO Stéphane Bancel says its COVID-19 vaccine could begin distribution as soon as December
  • Phase three trial delays could push distribution into early 2021.
  • Moderna expects to meet U.S. demand for the drug. It will also manufacture it in Switzerland for international distribution

Moderna says its COVID-19 vaccine could be ready for U.S. distribution as early as December.

Speaking at a Wall Street Journal tech conference, CEO Stéphane Bancel said Moderna expects interim results from phase three clinical trials by November, a timetable that could place an emergency approval from the FDA in December.

There are still some possible wrinkles, however: Moderna needs a minimum number of their 30,000 volunteers to contract COVID-19 before it can prove those without the vaccine were more likely to do so. Low infection rates could delay results.

If the results from that first population aren’t conclusive, Moderna would need to wait for a larger number of sick volunteers before seeking FDA approval. That would likely push a vaccine timetable into early 2021.

Hopes for a rapid vaccine faced a setback by the suspension of trials for two candidates Hopes for a rapid vaccine faced a setback by the suspension of trials for two candidates Photo: AFP / Ludovic MARIN

Last week vaccine competitor Pfizer said it would be seeking FDA approval in late November, as well, which would put its distribution date in December. Two other potential vaccines from Johnson & Johnson and AstraZeneca have their trials on hold pending investigations into unexplained illnesses among volunteers.

New FDA regulations require that vaccine developers wait two months from the last dose of their drug to prove long-term safety and efficacy. President Donald Trump fought their implementation, hoping to get a vaccine out before the November presidential election.

Both Pfizer and Moderna are set to clear this bar, with Moderna’s trials starting in July. It typically takes several weeks for the FDA to arrive at a decision once the drug is submitted, although if there was ever a drug that would be given extra resources it would be these.

Bancel said that Moderna projects it can produce 20 million doses in 2020, and 500 million in 2021. Moderna and its manufacturing partner, Lonza Ltd. say they will be able to meet U.S. demand. They will also be manufacturing the drug in Switzerland to distribute internationally.

Despite their expectations, Bancel said that manufacturing vaccines is a complex process with many moving parts that need to come together simultaneously.

“Unlike sometimes when you make a recipe at home, if you miss one ingredient, you might decide to still go ahead and make your meal,” he said, “In our case we cannot do that. We need all the ingredients to be there on time to be able to make a lot of vaccine.”

“If one ingredient is missing, we cannot make a vaccine.”

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Covid ‘test-and-release’ system for airlines hopefully in place by December, says Shapps

A ‘test-and-release system’ to cut the quarantine period for international arrivals to the UK should be in place by 1 December, the transport secretary has said.



Grant Shapps wearing a suit and tie smiling at the camera: Photograph: Toby Melville/Reuters


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Photograph: Toby Melville/Reuters

Grant Shapps said he was “extremely hopeful” that the system, which would require a single coronavirus test to be taken about a week after arrival and paid for privately, would be ready in six weeks’ time, depending on sufficient tests being available through the private sector.

Speaking to the aviation industry Airlines 2050 summit, Shapps said the government travel taskforce he chairs had been “working extensively with health experts and the private testing sector on the practicalities” of such a regime, as well as discussing possible pre-departure test and isolation schemes with partner countries.

He said the taskforce was in contact with more than a dozen firms about different rapid tests. The taskforce is due to report to the prime minister at the start of November on a reformed entry regime.

Asked if the test-and-release system could be running by 1 December, Shapps said: “As long as the [testing] capacity is there through the private sector to do it, I’m extremely hopeful.”

However, the new boss of British Airways signalled that even a seven-day quarantine period would not do much to restart travel.

Sean Doyle, who replaced Álex Cruz as BA chief executive last week, said: “It’s our view that even if that quarantine period is reduced to seven days, people won’t travel here and the UK will get left behind.”

He said BA wanted to see pre-departure testing, particularly to restore major transatlantic routes. BA is now flying two planes a day between London and New York, instead of the normal 12, carrying just 200 passengers, Doyle said.

Doyle quoted recent research by the global airline body Iata that showed there had been only 44 confirmed cases of aircraft passengers contracting Covid-19 onboard, including in the period before wearing face masks was mandatory. He said: “I find that pretty reassuring. That’s one in 27 million, and mostly before people wore face masks.”

Speaking to the summit, Doyle said: “We do not believe quarantine is the solution. The best way to reassure people is to introduce a reliable and affordable test before flying.

“If we look abroad to our near neighbours, we see that business travel and indeed tourism is being prioritised by some countries. We need to get the economy moving again and this just isn’t possible when you’re asking people to quarantine for 14 days.”

The trade body Airlines UK also questioned the value of the proposed regime. Its chief executive, Tim Alderslade, said: “Eight days, plus one or two days to get the results, isn’t going to have the impact we want. If you look at the average number of days people stay in the UK, from the US it’s about four days. Eight days isn’t going to cut the mustard.”



Grant Shapps wearing a suit and tie: Transport secretary, Grant Shapps, told the Airlines 2050 summit the new system could be in place by 1 December.


© Photograph: Toby Melville/Reuters
Transport secretary, Grant Shapps, told the Airlines 2050

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