The race for a Covid vaccine is reaching a crucial stage, with the glimmer of a possibility that one of the leading contenders will be approved by Christmas.

In an interview with the Guardian, Kate Bingham, who heads the UK’s vaccine taskforce, said the UK was in “a very good place”.

But there are still hurdles to clear in the coming weeks.

Within weeks, the first results to show whether one of the vaccines actually works will emerge. With a vaccine hailed as the world’s best hope of halting the deaths and the social and economic destruction wreaked by the Covid pandemic, the world is holding its breath.

It could be Oxford University, partnered with drug company AstraZeneca. It could be Moderna in the US. Or it could be Pfizer and the German company BioNTech.

All three have either recruited the last of the tens of thousands of volunteers they need for the critical final trials or will shortly do so.

And sometime in November or December, their independent monitoring boards will “unblind” their secret data to find out whether fewer people given the experimental vaccines are getting Covid-19.

The excitement is palpable. Bingham understands that.

“I can just see that it’s such an incredibly sensitive topic, that everyone is so desperate to be out of lockdown and get back to normal that everyone grabs at straws,” she said.

“I think my key message is we’re in a very good place. The UK is well set up, we’ve got a very attractive portfolio. We are absolutely well-planned and well-organised in terms of having the right vaccines and knowing when they’re arriving.”

The UK has bought six of the hundreds of vaccines under development. It has two of the three companies heading down the final furlong – AstraZeneca’s and Pfizer’s. Bingham says she thinks there is a chance of a vaccine before Christmas.

https://www.theguardian.com/world/2020/oct/30/its-possible-the-race-to-approve-a-covid-vaccine-by-christmas

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The U.S. pharmaceutical giant is preparing to ship billions of Covid-19 vaccines using frozen boxes, cargo planes and trucks in a mega logistics operation.

In Kalamazoo, Mich., a stretch of land the size of a football field has been turned into a staging ground outfitted with 350 large freezers, ready to take delivery of millions of doses of Covid-19 vaccine before they can be shipped around the world.

The facility is a hub in the sprawling supply chain Pfizer Inc. has built to handle the delivery of a vaccine widely awaited as a possible relief from the coronavirus pandemic. The U.S. pharmaceutical giant says it wants to deliver up to 100 million doses this year and another 1.3 billion in 2021.

Like other drugmakers testing potential vaccines, Pfizer is urgently laying the groundwork with its logistics partners so it can move quickly if its vaccine gets the go-ahead from the Food and Drug Administration and other regulators around the world.

“It’s the biggest-ever vaccination campaign,” said Tanya Alcorn, Pfizer’s supply-chain vice president. “If we get the FDA approval, we will be able to ship the vaccines very shortly after.”

The New York-based drugmaker is working with Germany’s BioNTech SE on one of several experimental Covid-19 vaccines in late-stage testing. Pfizer says it may know whether its vaccine works by the end of October and that it could be ready to apply for emergency-use authorization of its Covid-19 vaccine by late November.

The company’s effort to deliver relief to pandemic-weary populations will revolve around refrigerated storage sites at two of the company’s final assembly centers—the Kalamazoo facility and another in Puurs, Belgium—and rely on dozens of cargo-jet flights and hundreds of truck trips every day. Distribution centers in Pleasant Prairie, Wis., and in Karlsruhe, Germany, have been outfitted for extra storage capacity.

Pfizer so far has spent about $2 billion on developing the vaccine and setting up the distribution network.

https://www.wsj.com/articles/pfizer-sets-up-its-biggest-ever-vaccination-distribution-campaign-11603272614

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The U.K.’s drug regulator has started accelerated reviews of Covid-19 vaccines under development from Pfizer Inc. and AstraZeneca Plc, as Britain gets ready to approve the first successful shot as quickly as possible.

The U.K. Medicines and Healthcare Products Regulatory Agency started a so-called rolling review of the Pfizer vaccine in recent weeks, according to a person with knowledge of the situation who didn’t want to be identified because the procedure hasn’t been announced publicly. The agency is also conducting an expedited review of Astra’s vaccine, which the company is co-developing with the University of Oxford, a spokesman for Astra confirmed.

Rolling reviews allow regulators to see clinical data in real time and have discussions with companies about ongoing trials and manufacturing processes so that approvals can be granted more quickly. The approach is designed to speed up access to drugs and vaccines when there is a public health need.

The move supports the U.K.’s plans to potentially move ahead of the European Union on clearing a vaccine. While the U.K. is still subject to the approval process of the European Medicines Agency until the end of the Brexit transition process this year, the government has said that if there was a compelling case to move more quickly than the EMA, it would look at granting a temporary authorization for an unlicensed vaccine.

Moderna Inc., another frontrunner in the vaccine race, also said this week it had started an expedited review of its shot in the U.K. Rolling reviews of the Pfizer and Astra jabs in Europe were announced by the EMA earlier this month.

https://www.bloomberg.com/news/articles/2020-10-30/pfizer-astra-vaccines-said-to-be-in-accelerated-u-k-reviews

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The third and final clinical trial for Moderna’s coronavirus vaccine is still underway, but the company is already setting an aggressive schedule to manufacture and ship the vaccine immediately if the Food and Drug Administration approves it.

“By the end of this year, we expect to have approximately 20 million doses ready to ship in the U.S.,” Moderna chief medical officer Dr. Tal Zaks said at an investor briefing on Thursday. “From a distribution standpoint, we’re ready.”

The company has also agreed to supply several other countries including Japan, Canada, Switzerland, Israel and Qatar with tens of millions of doses, Zaks said. By the end of 2021, the company hopes to supply the world with up to a billion doses – or 500 million full courses of the two-dose vaccine.

But that hinges on whether the FDA and the equivalent regulatory agencies of other countries approve Moderna’s product, which is built on a new and untried vaccine technology. Moderna’s vaccine uses RNA, a type of genetic code that also served as the inspiration for Moderna’s name – a portmanteau of the words Mode and RNA. This genetic code instructs human cells to produce a coronavirus protein. The body’s immune system then generates a defensive response to that protein.

The ongoing third clinical trial for the vaccine will determine if that immune response is enough to protect against coronavirus infection. Until the results of that trial are out, there's no saying if the vaccine will really work.

According to the FDA, Zaks said, a final analysis of the clinical trial would need to show the vaccine is at least 50 percent effective for approval. But, he added, Moderna is setting a higher bar.

“In order to call it a success, we will need to show a vaccine efficacy of 74% or greater,” Zaks said during the investor meeting.

https://www.wbur.org/commonhealth/2020/10/29/moderna-vaccine-end-of-year

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As much of the world struggles to contain new waves of the Covid-19 pandemic, Taiwan just marked its 200th consecutive day without a locally transmitted case of the disease.

Taipei's response to the coronavirus pandemic has been one of the world's most effective. The island of 23 million people last reported a locally transmitted case on April 12, which was Easter Sunday. As of Thursday, it had confirmed 553 cases -- only 55 of which were local transmissions. Seven deaths have been recorded.

Easter was an important milestone in the United States because President Donald Trump had said a month earlier he wanted the country "opened up and just raring to go" by the holiday.

Taiwan has never had to enact strict lockdowns. Nor did it resort to drastic restrictions on civil freedoms, like in mainland China.

Instead, Taiwan's response focused on speed. Taiwanese authorities began screening passengers on direct flights from Wuhan, where the virus was first identified, on December 31, 2019 -- back when the virus was mostly the subject of rumors and limited reporting.

Taiwan confirmed its first reported case of the novel coronavirus on January 21 and then banned Wuhan residents from traveling to the island. All passengers arriving from mainland China, Hong Kong and Macao were required to undergo screening.

All this happened before Wuhan itself went into lockdown on January 23. By March, Taiwan banned all foreign nationals from entering the island, apart from diplomats, residents and those with special entry visas.

Former Taiwanese Vice President Chen Chien-jen, who is an epidemiologist by training, said lockdowns are not ideal. Chen also said that the type of mass-testing schemes undertaken in mainland China, where millions of people are screened when a handful of cases are detected, are also unnecessary.

"Very careful contact tracing, and very stringent quarantines of close contacts are the best way to contain Covid-19," he said.

https://edition.cnn.com/2020/10/29/asia/taiwan-covid-19-intl-hnk/index.html

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Ontario is slowing the growth of COVID-19, the provincial government’s key public-health advisers said Thursday, releasing new projections suggesting the province is, for now, on track to avoid overwhelming its hospitals.

In a briefing for media on Thursday, Adalsteinn (Steini) Brown, dean of the Dalla Lana School of Public Health at the University of Toronto, said Ontario is now seeing “much slower growth” and appears to be on a similar trajectory as the U.S. state of Michigan – rather than sharing the fate of the Australian state of Victoria, which was prompted to impose extremely strict lockdown measures as cases skyrocketed.

If current trends hold, Dr. Brown said, Ontario can expect a “steady state” of 800 to 1,200 cases a day. “Although cases are continuing to grow, that growth has slowed and we are starting to see a more gentle curve there."

https://www.theglobeandmail.com/canada/article-public-health-advisers-suggest-ontario-has-begun-to-flatten-the-covid/

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Medicare beneficiaries will now be able to get a free Covid-19 vaccine if one is approved early.

A rule change announced late Wednesday by the Centers for Medicare and Medicaid Services will allow full coverage for any Covid vaccine that gets approval, even if through emergency-use authorization.

The CARES Act, signed into law in March, called for no cost-sharing for Medicare beneficiaries for a Covid-19 vaccine once it’s available. However, under standard Medicare rules, the legislation would apply only to a vaccine that undergoes the standard approval process for new biologics, not one that is fast-tracked. 

The expectation is that the government would make the limited quantities of an early vaccine available to those most at risk for contracting Covid-19 or dying from complications caused by the virus.

That generally would include Medicare beneficiaries, the majority of whom are age 65 or older — an age group identified as high-risk. 

Medicare would pay $28.39 for a single-dose vaccine; if two doses were needed, the rate would be $16.94 for the first dose and $28.39 for the second.

https://www.cnbc.com/2020/10/29/medicare-will-cover-early-vaccines-for-covid-.html

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United Airlines passengers flying from New Jersey to London will undergo a mandatory COVID-19 test at the airport beginning next month in an experiment the airline hopes jump-starts international travel.

The good news for passengers: the test, required of all passengers over age 2 on select flights from Newark, is free.Other airport and airline COVID-19 test options are as pricey as $250 per person for on-site tests.

The bad news: passengers with negative test results won't be able to bypass a mandatory 14-day quarantine upon arrival in London, as they can on flights to Hawaii as of Oct. 15. (Passengers testing positive will not be allowed to board and will receive a refund.)

United executives said the goal of the pilot program, which will be offered three days a week on Flight 14 between Nov. 16 and Dec. 11, is two-pronged.

In the short term, the airline hopes it gives travelers peace of mind to book a trip because it guarantees that "essentially everyone on board has tested negative for COVID-19,'' according to Aaron McMillan, United's managing director of operations policy and support .

https://eu.usatoday.com/story/travel/airline-news/2020/10/29/united-airlines-pilot-free-airport-covid-19-tests-london-flights/6054283002/

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Moderna is prepping for the global launch of its potential coronavirus vaccine, already taking in $1.1 billion in deposits from governments awaiting the potentially lifesaving drug, the biotech firm said Thursday in its third-quarter earnings report.

The Cambridge, Massachusetts-based company said it was in ongoing talks with the World Health Organization-backed COVAX initiative on a tiered pricing proposal for its potential vaccine, which it’s tentatively calling mRNA-1273. It already has supply agreements in North America, the Middle East and in other regions of the world.

“We are actively preparing for the launch of mRNA-1273 and we have signed a number of supply agreements with governments around the world,” Moderna CEO Stephane Bancel said in a press release. “Moderna is committed to the highest data quality standards and rigorous scientific research as we continue to work with regulators to advance mRNA-1273.”

Moderna, a frontrunner in the Covid-19 vaccine race, said last week it had completed enrollment for its 30,000 participants late-stage trial. As of last week, more than 25,650 participants had received the second of the company’s two-dose Covid-19 vaccine. The company said about 37% of the participants were from diverse communities and 42% were at high risk of severe disease.

Just over half, 53%, of the participants in the trial are male and 47% are female, according to a presentation from the company. The vast majority of participants are over the age of 25, with only 5% in the 18 to 24 age group.

On a call with investors Thursday, Bancel said the company expects the data and safety monitoring board, which will assess whether the trial is successful, will conduct its first interim analysis in November. The board will not conduct its analysis until after there are 53 cases of Covid-19 diagnosed in Moderna’s phase three trial.

https://www.cnbc.com/2020/10/29/coronavirus-moderna-says-it-is-actively-preparing-for-launch-of-vaccine.html

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Up to 10% of England’s population could be tested for coronavirus every week after government officials asked local health chiefs to deploy 30-minute saliva kits in an acceleration of Boris Johnson’s controversial “Operation Moonshot” mass screening plan.

In a letter seen by the Guardian, NHS test and trace claims it is embarking on an “important new front in our fight against coronavirus” and asks all directors of public health to sign up to receive rapid-result test kits for up to a tenth of their populations every week, to contain outbreaks and preserve freedoms.

If delivered, it could result in a huge increase in national testing – up to 5m tests weekly from the current rate of about 300,000 so-called PCR tests a day, carried out by swabbing the nose and throat.

Last week Matt Hancock, the health secretary, told parliament the government had bought “many millions” of saliva tests made by the company Innova. Johnson said on 16 October that the tests would become available “to help control localised outbreaks” but the latest strategy also extends beyond saliva test trials announced for schools, universities and care homes.

In the leaked letter, Alex Cooper, director of rapid testing at NHS test and trace, said: “Each director of public health will be eligible to receive on a weekly basis the number of tests equivalent to 10% of their population.”

The rollout will be “phased” with areas under tier 3 restrictions – such as Liverpool and Manchester – prioritised, with the potential to test the whole local population every 10 weeks.

https://www.theguardian.com/world/2020/oct/28/10-of-englands-population-could-be-tested-for-covid-19-every-week

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