H5N1

Why emergency COVID-19 vaccine approvals pose a dilemma for scientists

Via Nature.com: Why emergency COVID-vaccine approvals pose a dilemma for scientists. Excerpt:

After a flurry of positive results from clinical trials of COVID-19 vaccines, developers are now seeking ‘emergency use’ approvals, which could see these immunizations deployed in potentially tens of millions of people. But scientists are concerned that this kind of early deployment could compromise the ongoing clinical trials that seek to show conclusively how well the vaccines work.  

Following the release of early data from phase III trials on 9 November, vaccine makers Pfizer and BioNTech have sought regulatory permission to deploy their vaccine under emergency-use rules. The developer of another leading vaccine, Moderna, is expected to do the same within weeks.  

Once a vaccine is granted emergency approval, there is pressure on developers to offer the immunization to trial participants who received a placebo. But if too many people cross over to the vaccine group, the companies might not have enough data to establish long-term outcomes, such as safety, how long vaccine protection lasts and whether the jab prevents infection or just the disease.  

“It’s a real vaccine development dilemma,” says Klaus Stöhr, who formerly headed vaccine design at the pharmaceutical company Novartis in Cambridge, Massachusetts, and is now retired. Still, Stöhr thinks that the vaccine should be granted emergency use authorization because its effectiveness has been established and there is a dire need.

Virological surveillance of influenza viruses in the WHO European Region in 2019/20 – impact of the COVID-19 pandemic

Via Eurosurveillance: Virological surveillance of influenza viruses in the WHO European Region in 2019/20 – impact of the COVID-19 pandemic. The abstract:

The COVID-19 pandemic negatively impacted the 2019/20 WHO European Region influenza surveillance. Compared with previous 4-year averages, antigenic and genetic characterisations decreased by 17% (3,140 vs 2,601) and 24% (4,474 vs 3,403). Of subtyped influenza A viruses, 56% (26,477/47,357) were A(H1)pdm09, 44% (20,880/47,357) A(H3). Of characterised B viruses, 98% (4,585/4,679) were B/Victoria. Considerable numbers of viruses antigenically differed from northern hemisphere vaccine components. In 2020/21, maintaining influenza virological surveillance, while supporting SARS-CoV-2 surveillance, is crucial.

US records seventh consecutive day of more than 100,000 new Covid-19 cases

Via The Guardian: US records seventh consecutive day of more than 100,000 new Covid cases. Excerpt:

Coronavirus continue to surge in the US, after the country recorded a seventh consecutive day of more than 100,000 new cases.  

Monday also saw the US surpass 10m total cases and reach an overall death toll of 238,256.  

There were 111,433 new cases on Monday and 590 new deaths, according to data compiled by Johns Hopkins University. 

Hospitalizations were also rising, with more than 59,000 hospitalized nationwide, reported the Covid Tracking Project, which saw the biggest single-day increase since 10 July. It found South Dakota had the highest hospitalization rates in the country and that Illinois had reported more than 10,000 cases for four days straight.  

Joe Biden, the president-elect, has warned the US is “facing a very dark winter” and that even with Pfizer’s announcement that it has a vaccine it believes is 90% effective, 200,000 more lives could be lost in the next few months. 

Alex Azar, secretary of health and human services, said on Tuesday the government will have enough of the vaccine by the end of December “to have vaccinated our most vulnerable citizens”.  

By the end of January, he told NBC, there will be enough for all healthcare workers and first responders, with March or early April targeted for a general vaccination program. 

In the meantime, states are struggling to cope. In El Paso, Texas, officials have six mobile morgues and have requested four more, CNN reported. The state was approaching 1m infections.  

Ohio’s chief medical officer, Dr Bruce Vanderhoff, warned of an “unprecedented spike” in hospital use and a growing demand on staff.  

“If we don’t control the spread of this virus, we won’t be able to care for those who are acutely ill without postponing important, but less urgent, care,” he said. “We anticipate that this kind of shift could happen in a matter of weeks if trends don’t change.”  

In Utah, Governor Gary Herbert warned of a “dire situation” in hospitals, declared a state of emergency, issued a mask mandate and restricted social gatherings. 

“This is a sacrifice for all of us,” he said. “But as we slow the spread it will make all the difference for our overworked healthcare workers, who desperately need our help.”

Why the COVID-19 and election stories will be hard to untangle

Via the Columbia Journalism Review: Why the coronavirus and election stories will be hard to untangle. Excerpt:

Last week, the pandemic continued not to respect editors’ and politicians’ priorities. The day after Election Day, the US recorded more than 100,000 confirmed cases of COVID-19—the first time any country had surpassed that daily rate. The same day, Mark Meadows, President Trump’s chief of staff, tested positive for the disease; he tried to keep his diagnosis under wraps, but the public found out about it on Friday via Bloomberg, which has become a preeminent source on the White House petri-dish beat. 

The day before Meadows’s positive test, he visited Trump’s campaign HQ and then attended a White House election party; according to Yamiche Alcindor, of PBS, aides feared the election party would be a COVID superspreader, but felt pressured to show up. The Housing and Urban Development Secretary Ben Carson, who also attended the party, has now tested positive for COVID; so, too, has David Bossie, who is spearheading Trump’s post-election legal fight. 

Back on the macro level, the US beat its own daily record for confirmed cases on Thursday, then again on Friday, then again on Saturday. By Sunday, the country had recorded its ten-millionth confirmed case. 

Records aside, this was all grimly repetitive; for months now, the COVID story has been a ceaseless cycle of infection, death, and administration fecklessness. Yesterday, however, felt like a possible inflection point, as two developments gave news consumers possible glimpses of light at the end of the tunnel. 

First, Joe Biden, the president-elect, unveiled a thirteen-member COVID task force that will help guide his pandemic response. Several of its members will be familiar to news junkies—Atul Gawande is a staff writer at the New Yorker, while Vivek Murthy, Michael Osterholm, Ezekiel Emanuel, and Celine Gounder all appear regularly on TV—but not in the “Trump-Fox-feedback-loop” sense to which we’ve all become accustomed. (A Biden-New Yorker feedback loop would be an interesting thought experiment, but still not a good way to run an administration.) 

The Washington Post covered the task force under a headline—“Biden announces coronavirus task force made up of physicians and health experts”—that, as the journalist and CJR contributor Gabriel Snyder noted, was overwhelming in its normality, “like reading ‘Dog Bites Man’ after a long spell cowering in fear about a crazy man who was going around biting everyone’s dogs.” 

Biden also held a press briefing and called on all Americans to wear masks, a presidential invocation of science that CNN’s Sanjay Gupta called “surreal.” Presidential invocations of bleach—which are actually surreal—will soon be a thing of the past.  

Also yesterday, the pharmaceutical giant Pfizer made a big announcement: according to an early analysis, a vaccine that the company has been developing with BioNTech, a German drugmaker, was more than ninety-percent effective among trial volunteers, with no serious safety concerns observed. 

Sarah Zhang—a science writer at The Atlantic who warned recently that it can be hard to tell what’s significant and what isn’t amid an unprecedented, dizzying flood of vaccine news—called the Pfizer announcement a “*big deal*”; around the world, medical experts debated the announcement, and reporters, as CNN’s Brian Stelter put it, “zigzagged between optimism and caution.” 

There were grounds for both: the ninety-percent finding was surprising and hopeful, but it’s not yet clear how long immunity from the vaccine lasts, and Pfizer has yet to show its work. (It made its announcement in a press release, not a peer-reviewed journal.) Even if all is well scientifically, we’re left with the thorny questions of production, distribution, and uptake. 

Still, appropriately nuanced coverage is always grounds for optimism; science, after all, is naturally zigzaggy. There’s reason to hope that Biden, as president, will drive fewer—and less anguished—COVID headlines than Trump has done, leaving more space in our collective attention span for the scientific method to play out in public.

Pfizer’s early data shows COVID-19 vaccine is more than 90% effective

This is the morning's big story; at the moment, the Dow Jones is up over 1,200 points on the news. I hope we won't be disappointed. Via The New York Times: Pfizer’s Early Data Shows Coronavirus Vaccine Is More Than 90% Effective. Excerpt:

The drug maker Pfizer announced on Monday that an early analysis of its coronavirus vaccine trial suggested the vaccine was robustly effective in preventing Covid-19, a promising development as the world has waited anxiously for any positive news about a pandemic that has killed more than 1.2 million people.  

Pfizer, which developed the vaccine with the German drugmaker BioNTech, released only sparse details from its clinical trial, based on the first formal review of the data by an outside panel of experts.  

The company said that the analysis found that the vaccine was more than 90 percent effective in preventing the disease among trial volunteers who had no evidence of prior coronavirus infection. If the results hold up, that level of protection would put it on par with highly effective childhood vaccines for diseases such as measles. No serious safety concerns have been observed, the company said. 

Pfizer plans to ask the Food and Drug Administration for emergency authorization of the two-dose vaccine later this month, after it has collected the recommended two months of safety data. By the end of the year it will have manufactured enough doses to immunize 15 to 20 million people, company executives have said.  

“This is a historical moment,” Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, said in an interview. “This was a devastating situation, a pandemic, and we have embarked on a path and a goal that nobody ever has achieved — to come up with a vaccine within a year.”  

Independent scientists have cautioned against hyping early results before long-term safety and efficacy data has been collected. And no one knows how long the vaccine’s protection might last. Still, the development makes Pfizer the first company to announce positive results from a late-stage vaccine trial, vaulting it to the front of a frenzied global race that began in January and has unfolded at record-breaking speed. 

Eleven vaccines are in late-stage trials, including four in the United States. Pfizer’s progress could bode well for Moderna’s vaccine, which uses similar technology. Moderna has said it could have early results later this month.

Six countries report COVID-19 on mink farms, WHO says

This is a rapidly developing story, and not an encouraging one. Via CTV News, an AFP report: Six countries reported coronavirus on mink farms, WHO says. Excerpt:

GENEVA, SWITZERLAND -- Denmark and the United States are among six countries that have reported new coronavirus cases linked to mink farms, the World Health Organization said.  

Italy, the Netherlands, Spain and Sweden are the other nations to have discovered SARS-CoV-2 in minks, WHO said in a statement. 

Denmark has imposed strict measures on the north of the country after warning that a mutation of the virus had jumped from minks to humans and infected 12 people. 

Copenhagen has warned the mutation could threaten the effectiveness of any future vaccine and has ordered the slaughter of all the estimated 15-17 million minks in the country. 

Britain on Saturday banned entry to all non-resident foreigners coming from Denmark after the mutation linked to mink farms was found in humans. 

Scientists say virus mutations are common and often harmless, and this one doesn't cause a more severe illness in humans. 

But Danish health authorities have expressed concern this strain, known as "Cluster 5", is not inhibited by antibodies to the same degree as the normal virus, which they fear could threaten the efficacy of vaccines that are being developed across the globe.

COVID-19 digest: US tops 100,000 new cases for first time

Via DW, a useful overview: Coronavirus digest: US tops 100,000 new cases for first time. Excerpt:

The United States has registered a one-day record for new coronavirus cases with over 100,000 new infections, according to tallies from the Washington Post and news agency Reuters. 

Nine states reported record one-day caseloads: Colorado, Idaho, Indiana, Maine, Michigan, Minnesota, Rhode Island, Washington and Wisconsin, in a period dominated by a presidential election that included a record number of voters mailing in their ballots. Many did so to avoid congested polling stations in order to stem the spread of the virus. 

In addition to rising infections, hospitalizations topped 50,000 for the first time in three months.

Europe  

Germany recorded a new record in daily cases on Thursday, with the Robert Koch Institute said there had been 19,990 new COVID-19 cases reported in the past 24 hours. 

The Berlin-based organisation, which is responsible for disease prevention and control, said the number of registered deaths rose by 181 over the same period to a total of 10,930.

The UK's Prime Minister Boris Johnson said Wednesday that his government could be ready to deliver a COVID-19 a vaccine in the first part of 2021. 

Britain's National Health Service is looking at two vaccines: one produced by German firm BioNtech and US pharmaceutical company Pfizer, and another from the University of Oxford and AstraZeneca. 

Any vaccine will need the approval of British regulators before it can be given to the public. 

Both vaccines are currently being tested out in clinical trials; the results are due before the end of this year.  

Hungary's foreign minister Peter Szijjarto has tested positive for the coronavirus during an official visit in Thailand, the Hungarian government said on Wednesday. 

Szijjarto in the only person from his 12-member delegation have been found to be infected. He will return on a separate plane back to Hungary later Wednesday. 

Belgium, proportionally still the worst-hit nation in Europe when it comes to coronavirus cases, said Wednesday there are increasing signs that a turning point in the crisis was drawing close. 

"The high-speed train is slowing down," said virologist Steven Van Gucht of the Sciensano government health group. "The infection center is stabilizing and hospital admissions are increasing at a slower pace." 

Belgium has the highest proportional incidence of coronavirus cases in the European Union with 1,753 per 100,000 people, while countries like Spain, Britain and Italy have less than a third of that concentration. 

In Italy, the government moved to tighten up a late-night curfew. The measures will forces Italians to stay indoors between 10 p.m. and 5 a.m.  

Several other European governments, such as France and Belgium have brought in similar measures aimed at slowing the spread of the virus.  

Austria released new data on Wednesday that showed that new daily coronavirus infections have climbed above 6,000 for the first time.  

As many as 6,211 were registered to have been infected with COVID-19, according to the country's heath and interior ministries. 

Switzerland too said it has seen an uptick in coronavirus cases, with 10,074 new infections and 73 more deaths. 

The World Health Organization says there has been a "further acceleration" in the speed of COVID-19's spread in Europe, which was responsible for about half of the globe's new cases reported last week.  

The UN health agency said in a weekly report published late Tuesday that European countries also recorded a 46% increase in deaths compared with the previous week. Although deaths also rose in the Americas, the rate of increase there was only 2%.

Brazil health minister back in hospital with COVID-19

Via Reuters: Brazil health minister back in hospital with COVID-19. Excerpt:

BRASILIA (Reuters) - Brazilian Health Minister Eduardo Pazuello, who is ill with COVID-19, will stay in a military hospital overnight on Sunday, after having been discharged from a civilian facility earlier in the day, the ministry said in a statement. 

Pazuello, an active duty Army general, will stay in the military hospital as “a precautionary measure,” the ministry said.    

“Pazuello is well and stable and should stay resting until tomorrow,” the statement said.  

The minister tested positive for coronavirus on Oct. 21. He checked into a hospital on Friday, suffering from dehydration, the ministry said earlier. 

Roughly half of right-wing President Jair Bolsonaro’s 23-member cabinet has gotten the coronavirus, with the president and his wife coming down with the disease in July.

In another Reuters report: Brazilians protest mandatory COVID-19 immunization, Chinese vaccine.

COVID-19: Vaccinating Germany could take until 2022, says chief virologist

Via DW: Coronavirus: Vaccinating Germany could take until 2022, says chief virologist. Excerpt:

Despite a global pharmaceutical rush to develop proven coronavirus vaccines, jabs for the 83-million people living in Germany could take until 2022, the chairman of the country's vaccination oversight commission, Thomas Mertens, said on Thursday.  

"Even though vaccines will soon be available, the vaccination of the entire population by the end of 2021 will, in my opinion, not be completed," Mertens told the Funke Media Group.  

Mertens, the head of the 18-member Standing Committee on Vaccination (Stiko) at the Robert Koch Institute (RKI), Germany's public health agency for disease control and prevention, also cautioned that it would "take a long time" for a noticeable change in the course of the infection across the entire population to emerge.  

"For example, if you vaccinate 100,000 people a day — and this is a challenge — it would take 150 days to vaccinate 15 million people," said Mertens, explaining the massive effort that will be required to provide vaccinations to everyone in Germany who wants one.  

Who gets the first shots? 

A public prioritization, for vulnerable people, such as the elderly, as suggested recently by German Health Minister Jens Spahn, could lead to wrangles, Mertens added.  

"It could happen that some who do not get an early chance will take legal action," he speculated.

The successful vaccination of Germany's population as a whole would not hinge on whether the campaign started "four weeks earlier or later" but on careful preparation and implementation, he insisted.

Transport and storage of doses would be important factors, Mertens said, as well as "the establishment of regional vaccination centers, simultaneous documentation of vaccinations nationwide, and the evaluation of safety aspects.”  

Good communication, targeted at every age group and people of all levels of education, will be decisive in creating the "greatest possible acceptance" for the distribution of a vaccine, he added.

What defines an efficacious COVID-19 vaccine?

Via The Lancet Infectious Diseases: What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. The summary:

The novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has caused more than 1 million deaths in the first 6 months of the pandemic and huge economic and social upheaval internationally. An efficacious vaccine is essential to prevent further morbidity and mortality. 

Although some countries might deploy COVID-19 vaccines on the strength of safety and immunogenicity data alone, the goal of vaccine development is to gain direct evidence of vaccine efficacy in protecting humans against SARS-CoV-2 infection and COVID-19 so that manufacture of efficacious vaccines can be selectively upscaled. 

A candidate vaccine against SARS-CoV-2 might act against infection, disease, or transmission, and a vaccine capable of reducing any of these elements could contribute to disease control. However, the most important efficacy endpoint, protection against severe disease and death, is difficult to assess in phase 3 clinical trials. 

In this Review, we explore the challenges in assessing the efficacy of candidate SARS-CoV-2 vaccines, discuss the caveats needed to interpret reported efficacy endpoints, and provide insight into answering the seemingly simple question, “Does this COVID-19 vaccine work?”