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Will Pfizer's Vaccine Be Ready in October? Here's Why That's Unlikely. – The New York Times

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In media appearances and talks with investors, Pfizer’s chief executive nearly always mentions a word that is so politically perilous, most of his competitors shy away from it: October.

“Right now, our model — our best case — predicts that we will have an answer by the end of October,” the chief executive, Dr. Albert Bourla, told the “Today” show earlier this month. In other interviews, he has said he expected a “conclusive readout” by then, with an application for emergency authorization that could be filed “immediately.”

Dr. Bourla’s statements have put his company squarely in the sights of President Trump, who has made no secret of his desire for positive vaccine news to boost his chances on Election Day, Nov. 3. “We’re going to have a vaccine very soon. Maybe even before a very special date,” Mr. Trump said recently.

And yet by all other accounts, the idea that it will be ready in October is far-fetched. Even if the vaccine shows promising signs in clinical trials — still a big if — the company will not have collected enough data by then to say with any statistical confidence that it is safe and effective.

By repeating a date that flies in the face of most scientific predictions, Dr. Bourla is making a high-stakes gamble. If Pfizer puts out a vaccine before it has been thoroughly tested — something the company has pledged it will not do — it could pose a major threat to public safety. The perception matters, too: If Americans see the vaccine as having been rushed in order to placate Mr. Trump, many may refuse to get the shot.

But there is a significant upside, to the tune of billions of dollars, in being first to the U.S. market with a vaccine. And staying in the president’s good graces — particularly when he keeps talking about ways to lower drug prices — might not be a bad thing for a company that brought in nearly $40 billion in 2019 from sales of high-priced, brand-name drugs.

“There’s a huge financial advantage to being first out of the gate,” said Dr. Megan Ranney, an associate professor of emergency medicine and public health at Brown University. She was one of 60 public health officials and others in the medical community who signed a letter to Pfizer urging it not to rush its vaccine.

And given the White House’s persistent efforts to interfere in the decisions of federal health agencies, some scientists fear a vaccine approval could come under similar pressure.

“What I worry about is that the politics or the financial gain may drive earlier release than is scientifically appropriate,” Dr. Ranney said.

Pfizer will not be anywhere near completion of its clinical trial by the end of October, according to a company spokeswoman. When Dr. Bourla referred to a “conclusive readout” next month, she said, he meant that it’s possible the outside board of experts monitoring the trial would have by that date found promising signs that the vaccine works.

Pfizer’s trial blueprints allow the panel to look at the data after just 32 volunteers have become ill with Covid-19. Even if most of those cases were in the placebo group, regulators at the Food and Drug Administration would likely need data from more volunteers before making a decision on authorization, according to people familiar with the government’s vaccine approval process.

The F.D.A. has also told vaccine makers that they will need to track at least half of the patients’ safety data for two months before the agency will grant emergency access. That would push the earliest possible date into at least November.

In a statement, Pfizer said that it would continue to collect data on trial volunteers’ health for two years, and that it planned to submit two months of safety data to the agency “to help inform F.D.A.’s ultimate determination of authorization or approval.”

Credit…Samuel Corum for The New York Times

In public interviews, government health officials have refuted the October date. Both Dr. Moncef Slaoui, the chief scientific adviser to Operation Warp Speed, the federal effort that has awarded billions of dollars to vaccine makers, and Dr. Anthony S. Fauci, the nation’s top infectious disease doctor, have said October was unlikely.

Pfizer’s leading competitors in the vaccine race, Moderna and AstraZeneca, have been more vague about timing, saying they expect something before the end of the year. In a recent interview, Moderna’s chief executive, Stéphane Bancel, said: “October is possible, because very few things in life are impossible.” The better word, he said, is “unlikely.”

“They will not get approved before the election,” said Ronny Gal, an analyst with the Wall Street firm Bernstein. “The timing just doesn’t work.”

One key to understanding how Pfizer vaulted to first place in the vaccine race is found in its trial blueprints, known as a protocol.

Even though Moderna and Pfizer began their trials on the same day, Pfizer’s is “built for speed,” as one Wall Street firm, SVB Leerink, described it.

Participants in Pfizer’s trial are given two doses of a vaccine 21 days apart, whereas those in Moderna’s wait 28 days in between. Pfizer begins looking for sick volunteers seven days after the second dose, whereas Moderna does so at 14 days. And Pfizer’s plan allows an outside review panel to look at early data after just 32 volunteers have become ill with Covid-19. Moderna’s plan doesn’t allow for a first peek until 53 cases.

Some experts have speculated that Pfizer’s volunteers happen to be in places where the virus is spreading quickly, making it more likely that they would have been exposed to the virus and put the vaccine to the test. While Moderna’s trial is being conducted only in the United States, Pfizer’s is international, with locations set up or planned in the United States, Brazil, Turkey and Argentina.

In Argentina, which has seen a surge of coronavirus infections since August, 33,000 volunteers quickly signed up for about 4,500 slots, said Dr. Fernando Polack, the head researcher of the Pfizer study that is being carried out at the Hospital Military Central in Buenos Aires.

“We have a lot of years of experience in these kinds of trials, and we’ve never seen these numbers before,” Dr. Polack said in an interview. He declined to comment on whether he was aware of any Covid-19 cases among volunteers.

Across all of its trial sites, Pfizer said, 24,000 volunteers have received the second dose of the vaccine, more than half of the 44,000 that are expected to enroll.

Credit…Marco Bello/Reuters

Despite Pfizer’s confident pronouncements, a win is not guaranteed. Around 15 percent of vaccines in late-stage trials do not make it to approval.

Dr. Mark Goldberger, an infectious disease expert at the Global Antibiotic Research and Development Partnership and a former F.D.A. official, noted that the agency has scheduled a meeting of outside experts to discuss experimental coronavirus vaccines on Oct. 22.

“It would take an enormous effort to get the data by then,” he said. “It’s within the realm of possibility, but there are things that could trip them up — a manufacturing issue, a safety issue, the efficacy is not as good as they expect.”

Taking first place in the vaccine race isn’t just about bragging rights, although the public-relations boost from developing a vaccine that could liberate the world from a deadly pandemic can’t be understated.

Mr. Gal, the Bernstein analyst, said that Pfizer could win a significant commercial edge by taking control of the early market for a coronavirus vaccine. Unlike Johnson & Johnson and AstraZeneca, which have said they will not profit from their products during the pandemic, Pfizer has made no such promises.

It also has not taken federal money to develop its vaccine, instead signing a $1.95 billion deal to sell the first 100 million doses of its vaccine to the U.S. government. Dr. Bourla has said that the company didn’t accept federal investment in its research and development so that the government wouldn’t be able to control the price of the vaccine later on.

“We didn’t take money so that we don’t have any restrictions,” Dr. Bourla said on Sept. 16 at an event organized by the investment bank J.P. Morgan. “Because I can imagine, if you take money, then you have to — a little bit to explain about your pricing.”

While smaller companies like Moderna have already benefited financially by rising share prices, Pfizer has not seen a similar stock bump. Mr. Gal has estimated the initial wave of vaccination as an $18 billion market. “So to the extent that they are able to capture any material amount of it, even for a company like Pfizer, it’s not a small thing,” he said.

Pfizer also has more at stake when it comes to doing business with the federal government. Moderna does not sell any approved products, but Pfizer has a broad portfolio of vaccines and drugs. The federal government is both a major customer — paying for treatments and vaccines through Medicare — and makes weighty decisions about everything from drug approvals to drug-pricing policy.

Even as Mr. Trump has urged the speedy approval of a vaccine, he has employed harsh rhetoric against the industry. Earlier this month, he issued an executive order aimed at lowering the cost of some drugs by tying them to prices in other countries. The measure was strongly opposed — and is likely to be challenged in court — by the drug industry.

Earlier this month, the president singled out Pfizer for special praise, describing it as a “great company,” and saying he had spoken to Dr. Bourla, who was a “great guy.”

Dr. Bourla, who has spent much of the past month giving interviews to media outlets and appearing on industry panels, has insisted the company’s accelerated timeline had nothing to do with politics. “We have politicians or journalists speaking about efficacy or safety about medicines which, of course, is not appropriate,” Dr. Bourla said at the company’s investor day on Sept. 15. “The scientists should be having these discussions.”

Ultimately, Pfizer’s strategy may be about managing the public’s expectations, said Brandon Barford, a partner at Beacon Policy Advisors, a research firm. Pfizer could now explain any delay past October by “saying, ‘We’re being extra cautious.’ And you get kudos for it.”

But if the opposite occurs, and Pfizer is seen to be pushing a vaccine before it is ready, the “potential fallout is enormous,” said Dr. Ranney, of Brown University. “We cannot afford to have a vaccine released for Covid-19 that is either unsafe or ineffective.”

Sharon LaFraniere, Daniel Politi, Noah Weiland and Katherine J. Wu contributed reporting.

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Hospitals struggle as 20 European countries record highest daily number of COVID cases – ABC News

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Europe’s coronavirus second wave is in full swing with 20 countries on the continent, including the UK, Italy and Switzerland, reporting record numbers of COVID-19 infections.

The UK topped the list with 26,668 new cases and 191 coronavirus-related deaths in the previous 24 hours, while Italy recorded an additional 15,199 infections, up from its previous record of 11,705 on Sunday.

The Czech Republic saw an increase of 11,984 cases on Wednesday, while Poland recorded 10,040 and Switzerland had 5,596 new infections.

The records are following a worrying trend in Europe which is forcing governments to reintroduce restrictions on social interaction and hospitality services throughout the continent.

According to data from the European Centre for Disease Prevention and Control (ECDC), Europe has registered more than 5 million cases and 200,000 deaths, with new cases beginning to rise sharply from the end of September.

Meanwhile, Spain has become the first western European country to reach more than 1 million confirmed cases after reporting 16,973 additional cases in the past 24 hours.

The country has 34,366 confirmed deaths.

European Union leaders will hold a video-conference next week to discuss how to better cooperate as the infections rise.

Hospitals struggle to cope

A group of health workers in PPE surround a male patient on a stretcher
Health authorities across Europe are worried about hospital bed and ICU capacity as COVID-19 cases soar.(Reuters: Eric Gaillard)

With case numbers that were brought largely under control by lockdowns in March and April now surging, authorities in countries from Poland to Portugal have expressed mounting alarm at the renewed crisis confronting their health infrastructure.

Belgium, struggling with what its health minister called a “tsunami” of infections, is postponing all non-essential hospital procedures, and similar measures are looming in other countries where case numbers have been rising relentlessly.

“If the rhythm of the past week continues, rescheduling and suspending some non-priority activities will become unavoidable,” Julio Pascual, medical director at Barcelona’s Hospital del Mar, told Reuters.

European countries boast some of the world’s best health services and doctors say that with the benefit of almost a year’s experience with coronavirus, they are much better equipped to treat individual patients clinically.

But the capacity of hospitals to handle a wave of COVID-19 patients, as well as people suffering from cancer, heart disease and other serious conditions, is still vulnerable.

Dutch health authorities said if the number of COVID patients in hospital wards continues to grow, three quarters of regular care may have to be scrapped by the end of November, and there were similar warnings from Czech authorities.

“We have hit a wall on clinical beds,” Wouter van der Horst, spokesman for the Dutch hospital association NVZ, said.

‘We couldn’t get to everyone’

As hospital admissions have spiralled, much attention has been focused on intensive care units, which came close to being overwhelmed in many areas during the first wave of the crisis.

On Wednesday authorities in Lombardy, the Italian region at the centre of the first wave of the pandemic, ordered the reopening of special temporary intensive care units set up in Milan and Bergamo that were shut down as case numbers receded.

Already, a number of regional health authorities in Germany, one of the countries that dealt with the first wave most effectively, have agreed to take in intensive care patients from other countries.

The ECDC said that some 19 per cent of patients diagnosed with COVID-19 are estimated to have ended up in hospital and eight per cent of those could require intensive care, but variations are wide both across Europe and within individual countries.

On Wednesday, Poland’s Health Minister said up to 30 per cent of new cases there could end up being hospitalised.

There has also been concern over the track and trace systems meant to keep local outbreaks of the disease under control but those systems have proven ineffective in many areas.

Authorities in Ireland, where the five-day case average has tripled since the start of October, said there were no longer enough officials to keep the system working.

Niamh O’Beirne, national lead for testing and tracing, told RTE radio that contact tracing centres had seen “unprecedented demand” with exponential growth in the number of cases, “and over the week we simply couldn’t get to everyone”.

ABC/wires

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Fraser Health names two weddings for potential coronavirus exposure | News – Daily Hive

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Fraser Health is alerting the public about two weddings this month where guests could have been exposed to coronavirus.

The two weddings in the Fraser Health region both happened on October 10. The first was in Port Moody at Saint St. Grill. The exposure time applies all day from 5 am to 11 pm.

The second was in Mission at Lake Errock, again from 5 am to 11 pm.

The alert comes on the same day that Provincial Health Officer Dr. Bonnie Henry threatened further restrictions could be enacted as social gatherings including weddings and funerals fuel the province’s second wave of coronavirus cases.

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Ontario reports 841 new COVID-19 cases and another hospital outbreak

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A COVID-19 outbreak at a Quebec pork-processing plant grew Thursday as Manitoba expanded its restrictions and Alberta announced a testing pilot at two international border crossings that it hopes will eventually boost its ailing travel industry.

Olymel said 62 workers at its plant southeast of Quebec City had tested positive for the novel coronavirus.

The union representing plant workers is calling for a temporary closure, but the company says it is following guidance from public health officials who have not recommended a shutdown.

One worker died following a positive test result, but it wasn’t yet determined whether the death was due to the novel coronavirus.

Quebec, the province hardest-hit by COVID-19, reported 1,033 new cases Thursday and 20 additional deaths. Five hundred and fifty-three people were in hospital, including 101 in intensive care.

Premier Francois Legault said chances are slim restaurants in Quebec’s largest cities will be allowed to reopen this month as the province continue to report daily case increases in the quadruple digits.

Montreal and Quebec City have been under a 28-day partial lockdown since Oct. 1.

“At this time, we need to reduce even the risk of contact because we cannot afford to continue having about 1,000 new cases every day,” Legault said.

Manitoba reported four COVID-19 fatalities on Thursday in its deadliest day yet.

Dr. Brent Roussin, the chief provincial public health officer, announced 147 new cases — 87 in Winnipeg, where more restrictions on restaurants, pubs and gathering sizes came into effect this week.

He said the measures will also apply to the northern health region and Churchill starting next week. Extra measures are being put in place for schools in the Winnipeg area and the north starting Monday, including cancelling field trips, banning choirs and wind instruments and requiring substitute teachers to wear medical masks.

Manitoba’s daily test positivity rate is up to 5.6 per cent.

“We have to change things. We fell back on the fundamentals,” Roussin said. “We got back to all that normalcy that we want, but we just know this is what happens when we attempt that.”

Also Thursday, the European Union’s council reimposed a travel ban on Canada, reversing a decision in June that lifted entry restrictions on a number of non-EU countries. Europe is battling a second wave of the pandemic.

In Alberta, Premier Jason Kenney announced a joint federal-provincial pilot project that will enable international travellers re-entering Canada via the Calgary International Airport or the Coutts land border crossing from Montana to avoid a full 14-day quarantine. Instead, they would only have to isolate for a matter of days.

The pilot is to begin on Nov. 2 and is open to asymptomatic travellers returning to Canada who are Canadian citizens, permanent residents or foreign nationals permitted to enter Canada.

“Though a lot of work lies ahead, we can see a return to normal travel,” said Kenney. “The results will help shape provincial and federal policy and ultimately they’ll help to find a new approach for international travel.”

Those who voluntarily participate will receive a COVID-19 test upon entry into Canada before going into quarantine. If the result is negative, they can leave, as long as they promise to get tested six or seven days later at a pharmacy.

Participants will be subject to daily symptom checks and will have to wear masks in public places and avoid visiting high-risk groups.

Anyone who chooses not to get a test will still have to quarantine for two weeks.

Kenney said the provincial tourism industry has suffered a 63 per cent drop in spending this year. He also noted that three per cent of the province’s active cases were acquired through travel.

“We must find ways to bring back safe travel if we’re ever going to get the economy firing again on all cylinders.”

Kenney made his remarks by phone as he was self-isolating at home. The premier tested negative for the novel coronavirus on Wednesday, but said he will remain in isolation for another week.

Kenney attended events with Municipal Affairs Minister Tracy Allard, who contracted COVID-19 last week.

Alberta reported 427 new infections in Thursday’s update, a new record and the second day in a row its daily case count breached the 400 mark. Its test positivity rate was at three per cent on Wednesday.

Ontario Premier Doug Ford said his government is keeping a “sharp eye” on the Alberta border pilot project.

“I’d be open to it, but I just first want to see what’s happening in Calgary,” said Ford, who noted that Pearson International Airport in Toronto gets far more volume and international traffic.

Ontario reported 841 new cases of COVID-19 on Thursday as two more Toronto hospitals declared outbreaks.

Canada’s most populous province also recorded nine more deaths and had a daily test positivity rate of 2.5 per cent.

Two hundred and seventy people were in hospital, including 74 in intensive care and 48 on ventilators.

The Scarborough Health Network said six patients were infected in one unit at its general hospital, and the University Health Network said it was dealing with an outbreak involving four patients at the Toronto Rehabilitation Institute.

St. Michael’s Hospital, St. Joseph’s Health Centre, Toronto Western Hospital and the Centre for Addiction and Mental Health have also declared outbreaks among staff or patients.

This report by The Canadian Press was first published Oct. 22, 2020.

Source: – Kamloops This Week

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