Category: Covid-19 Vaccine

The coronavirus vaccine being developed by Pfizer and BioNTech has been found to be 90% effective in preventing people from getting the virus.

Phase 3 of Pfizer's trial involved 43,538 participants from six countries. They received two doses of either the immunisation or a placebo, with 90% protected from the virus within 28 days of having their jabs.

Only 94 people who took part in the trial developed coronavirus and no serious safety concerns were reported, the US pharmaceutical firm said.

"Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19," said Pfizer chairman and chief executive Dr Albert Bourla.

"With today's news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.

The news saw stock markets surge, with the FTSE 100 jumping by 5.5% - adding 82bn to the value of its shares and resulting in its best trading day since March.

Pfizer and BioNTech's vaccine is one of around 12 worldwide in the final stages of testing, but it is the first to produce any results.

The US and German companies say they can supply 50 million doses by the end of 2020 and 1.3 billion by the end of 2021.

The UK government has secured around 40 million doses - enough for 20 million people - and could roll out 10 million by the end of the year if they are approved for use in time.

Pfizer says that it will apply to the US healthcare regulator - the Food and Drug Administration - by the end of this month for emergency approval to use the vaccine.

A UK government spokesman said it is "optimistic about a breakthrough" but urged people to remember "there are no guarantees".

When the NHS is ready to roll out the vaccine, people who live and work in care homes will be top priority, followed by the elderly and the clinically vulnerable, they added.

Chief medical officer Professor Chris Whitty described it as "a reason for optimism for 2021".

But Brendan Wren, a professor of microbial pathogenesis at the London School of Hygiene and Tropical Medicine, suggested it may prove difficult for GPs to store the vaccines as they must be kept at -80C temperatures.

He told Sky News: "You can certainly make a lot of it but whether you could get it to everybody that needs it is another issue and that's why it's good that there are other vaccines available."

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Sky News science correspondent Thomas Moore said the results "exceed the expectations of many scientists".

Peter Horby, professor of emerging diseases and global health at the University of Oxford, described the development as a "watershed moment".

He said: "This news made me smile from ear to ear. It is a relief to see such positive results on this vaccine and bodes well for COVID-19 vaccines in general."

Michael Head, senior research fellow in global health at the University of Southampton, commented: "This cautiously sounds like an excellent result from the Phase 3, but we should remain a little cautious - the study is ongoing.

"However, if the final results show an effectiveness of anywhere near 90% with response in elderly and ethnic minority populations, that is an excellent result for a first generation vaccine."

William Schaffner, infectious disease expert at Vanderbilt University Medical Center in Nashville, Tennessee, added: "The efficacy data is really impressive.

"This is better than most of us anticipated. I would have been delighted with efficacy of 70% or 75%, 90% is very impressive for any vaccine. The study isn't completed yet, but nonetheless the data looks very solid."

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Coronavirus: Pfizer COVID-19 vaccine found to be 90% ...

Pharmaceutical giant Pfizer has announced that its COVID-19 vaccine successfully prevented 90% of disease compared to a placebo, a more positive result than experts expected.

The analysis is based on 94 cases of infection with SARS-CoV-2, the virus that causes COVID-19, among both the vaccinated and placebo groups. Experts had set a minimum threshold of 60% effectiveness for vaccines to be considered for emergency authorization or approval. The results included data from 38,955 of the total 43,538 volunteers who enrolled.

Immediately, as with much of the U.S.s pandemic response, the results were quickly thrown into the political blender of opinion, with President Donald Trump and his team taking to social media to tout the government support that made the promising results possible. In fact, Pfizer did not receive federal funding from the Operation Warp Speed (OWS) program that supported development of some of the vaccines currently in late stage testing. The company also plans to pack, ship and distribute its vaccine using its own system and not the network being built by OWS. In July, the company signed a contract with the government to provide 100 million doses of vaccine with a potential for several million more if the vaccine is authorized for distribution by the Food and Drug Administration.

Pfizer is the first company to release results from its COVID-19 vaccine, part of a planned interim analysis by an independent data safety monitoring board that is reviewing all of the handful of vaccine candidates from different companies that are currently being tested in people. The findings represent results collected seven days after the second of Pfizers two-shot regimen.

Pfizer, which developed and is testing its vaccine with German company BioNTech, said in a release that it will continue following study participants for a couple more weeks, until the middle of November, when everyone in the study will have been followed for at least two months. Thats the timeframe the Food and Drug Administration is requiring for COVID-19 vaccines before considering them for emergency authorization or approval, and also when the data safety review boards next scheduled analysis of the data will occur.

The encouraging results were revealed to Pfizer officials yesterday, on Nov. 8, by the five-member data safety monitoring board. They were incredibly poker-faced, right up until they reported the results, says Bill Gruber, head of clinical vaccine research and development at Pfizer. I have been in vaccine development for more than 35 years, and in my most optimistic moment did not expect efficacy of 90%. My most optimistic expectation was 75% or 80%, so this is a remarkable outcome.

Its important to note what that effectiveness means. The results do not reflect complete or so-called sterilizing immunity against infection, but rather protection against COVID-19 illness and its serious consequences once someone has been infected. In fact, the study was not set up to test people regularly and compare those who were negative versus those who were positive in each of the vaccine and placebo groups. Instead, all of the participants were asked to report any symptoms of COVID-19 they experienced, including fever, shortness of breath, sore throats and intestinal problems. Once they reported symptoms, they were tested for SARS-CoV-2, either by requesting a swab to take a sample themselves, or by reporting to their trial site for a test. Researchers then looked at those who were confirmed to be infected, and compared disease outcomes among those getting the vaccine and those getting a placebo in this group.

Gruber says its possible, however, that the vaccine is also protecting against infection, because many people experience COVID-19 without any symptoms. The full set of data will investigate other important questions such as whether the vaccine can protect people from getting infected in the first place. Before I began the study, I wasnt particularly optimistic that there would be high level protection against infection, he says. Now, given the high level of protection [we see] for relatively mild disease, suggests to me that there is a chance to protect against infection as well. But we wont know the answer to that until the end of the trial. Additional data may also reveal how contagious people who are infected but asymptomatic might be, which is an important public health question and critical to containing the pandemic.

So far, however, the results represent good news for not only for public health but for science as well. The companies vaccine is based on a new technology that relies on a genetic material known as mRNA. No mRNA-based vaccines have received approval from the FDA yet, although several are being tested for other diseases. The results are a testament to the benefits of the platformusing mRNA speeds up development of a vaccine since the process does not require growing vast amounts of virus.

Instead, vaccine developers only needed the genetic sequence of SARS-CoV-2, which became available in January, to start building a vaccine. Other companies, including Massachusetts-based Moderna, and vaccine giant Sanofi, are also testing mRNA COVID-19 vaccines.

This is a developing story and will be updated throughout the day.

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Pfizer Says COVID-19 Vaccine 90% Effective Against Virus ...

By Carl O'Donnell

NEW YORK(Reuters) - Drugmakers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway. Some companies had suggested early trial data could be ready for release in October, but have since pushed that back to November and December.

The following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over a million lives worldwide:

Who is furthest along?

U.S. drugmaker Pfizer Inc with German partner BioNTech SE, and U.S. biotech Moderna Inc could have early data in November. Britain-based AstraZeneca Plc, in conjunction with University of Oxford, and Johnson & Johnson say they are on track to deliver data for their vaccines this year.

What happens in these trials?

The companies are testing their vaccines against a placebo - typically saline solution - in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot.

Why are data reports delayed beyond original predictions?

The trials rely on subjects becoming naturally infected with the coronavirus, so how long it takes to generate results largely depends on how pervasive the virus is where trials are being conducted. Each drugmaker has targeted a specific number of infections to trigger a first analysis of their data.

Pfizer, for instance, believes it may know if its vaccine works once 32 people contract COVID-19 in the 44,000-person trial, as long as the overwhelming majority of those infected had received the placebo.

But drugmakers have said an insufficient number of infections prior to the recent spikes in cases slowed their ability to present data earlier. Pfizer in October said it did not expect to have usable trial data until late November due to slow infection rates. It had previously suggested that would happen in October.

Story continues

AstraZeneca said a slowdown in infections during the summer delayed its UK trial and that it expected to have results by the end of the year. Its timeline was also extended by a pause to investigate an illness in a UK trial participant.

After a slowing of infections in late summer and early autumn, COVID-19 cases were rampant again in October and early November, setting daily records in the United States and Europe as the weather cooled and people moved indoors. Experts have suggested that trial participants may also have been more careful to avoid contracting COVID-19 than the general population knowing they may have received a placebo.

How will we know if the vaccine works?

The United States, the European Union, the United Kingdom and the World Health Organization have all set similar minimum standards for effectiveness. Some regulators have said that vaccines must demonstrate at least 50% efficacy - meaning at least twice as many infections among volunteers who got a placebo as among those in the vaccine group. The European Medicines Agency has said it may accept a lower efficacy level.

When will regulators decide?

Regulators will review the vaccines after the companies have enough data to submit applications seeking emergency use authorization (EUA) or formal approval. The earliest they could decide is in December because Moderna and Pfizer/BioNtech do not expect to have enough safety data until the second half of November. U.S. regulators have asked that participants be watched for side effects for two months after receiving a final vaccine dose. AstraZeneca could provide a look at late-stage data by the end of the year. UK officials said there is a slight possibility they could decide on that vaccine in late December.

Regulators for Europe, the United Kingdom and Canada are considering data on a rolling basis, as it becomes available. They expect to do speedy reviews of initial data for possible emergency use before more traditional lengthy reviews for formal commercial approvals.

Could these be the first approved coronavirus vaccines?

Yes, although China and Russia are on a similar timeline. China launched an emergency use program in July aimed at essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people. At least four vaccines are far along including from China National Biotec Group [CHNAPF.UL] (CNBG), CanSino Biologics and Sinovac. Sinovac and CNBG have said to expect early trial data as soon as November. Russia's Gamaleya Institute has begun a 40,000-person late-stage trial and is expected to have early data in November. Russia has also given the vaccine to at least hundreds of "high-risk" members of the general population.

(Reporting by Carl O'Donnell in New York; Additional reporting by Julie Steenhuysen in Chicago, Michael Erman in New York, Ludwig Burger in Frankfurt, Alistair Smout in London and Polina Ivanovo in Moscow; Editing by Caroline Humer and Bill Berkrot)

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Q&A: Where are we in the COVID-19 vaccine race?

Counties plan for first round of COVID-19 vaccine; most will have to wait until 2021  WKRC TV Cincinnati

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Counties plan for first round of COVID-19 vaccine; most will have to wait until 2021 - WKRC TV Cincinnati

Pfizer and BioNTech released early study results indicating that their vaccine prevented more than 90% of infections with the virus that causes COVID-19. USA TODAY

The Knox County Health Department is gathering supplies and preparing staff to administer the first batch of COVID-19 vaccines as soon as they're ready, perhaps as soon as the end of the year.

But for almost all of us, don't expect to be among the first to get the shot.

Guidelines from the Centers for Disease Control and Prevention and the Tennessee Department of Health dictate that the vaccine be given to groups based on priority with medical providers and first responders at the front of the line, Health Department Director Dr. Martha Buchanan told the county commission Monday night.

From there, she said, the vaccine will be given to long-term care providers and others who provide services that put them at risk of getting COVID-19. Next up will be people categorized as susceptible because of age or medical conditions.

(Photo: Getty Images)

Children will not be eligible for the first vaccine, Buchanan said, because it has been tested only on adults and children have a higher immunity to the virus.

RELATED: Pfizer's COVID-19 vaccine candidate shown to be 90% effective in early findings

The health department has been told to be ready to distribute a vaccine by late November or early December, though theres no guarantee it is ready that quickly. There's been a buzz of anticipation after the drug company Pfizer and its partner, the German company BioNTech announced test results that showed its vaccine was 90% effective in preliminary trials.

Experts do not think the vaccine will be available with the speed and in quantities to do much at all in the next several months to mitigate the pandemic.

Im just being really honest and transparent. I think distribution will go slowly, Buchanan said.

COVID-19 WINTER: Surging COVID-19 cases in Tennessee make promising Pfizer vaccine irrelevant heading into winter

There were 75 people hospitalized in Knox County with the virus Monday, and 119 people have died here since the pandemic arrived early this year. Most of those deaths have occurred since June 30 the virus has killed 114 people in the past 132 days.

Public health officials are warning the disease is likely to surge again worldwide as winter approaches and people are indoors more often, and as people gather with friends and family for the holidays.

Pfizer is the first drug company to release data from a large, Phase 3 trial as it and several other companies are working to produce a COVID-19 vaccine that is safe and effective.

Like other vaccines, Buchanan said, the health department wont be the only (or largest) distributor. Local hospitals and doctors offices, among others, will administer the treatment as well.

Knox County Health Department Director Dr. Martha Buchanan speaks during a news conference at the City County Building in downtown Knoxville on April 27, 2020.(Photo: Brianna Paciorka/News Sentinel )

This particular vaccine is expected to come in 975-dose batches, Buchanan said. It is unclear how many batches the county can acquire at one time, but whatever the number is, Buchanan said she doesnt want to hoard supplies that might get better use in other parts of the country.

We will make sure we get adequate supplies based on our demand, but weve also learned from 13 years of in-school vaccinations that vaccine uptake (the percentage of those who agree to get the vaccine) varies and we dont want to waste such valuable resources by having too much on hand and having too much discarding, she said.

The vaccine is expected to require two doses, likely 21-28 days apart, Buchanan said. This gives your immune system a chance to produce antibodies and makes it less likely to get COVID-19, she said.

Pfizers vaccine is unique in that it must be stored at about negative-97-degrees Fahrenheit, requiring either rotating amounts of dry ice or an ultra-cold freezer.

A shot is prepared as part of a possible COVID-19 vaccine developed by the National Institutes of Health and Moderna Inc. in Binghamton N.Y.(Photo: Hans Pennink)

Funding for the supplies needed for this vaccine will come from the $7.1 million in CARES Act funding the county commission allotted the health department earlier this year.

There are other vaccines coming down the pipe and because this one has such rigorous storage requirements that Id imagine when others that are easier to store become available, well get those as well, she said.

So, I dont want to put too much money in the super-cold storage, but I want to have adequate storage so we can meet the demand.

USA TODAY contributed to this report.

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Knox County is prepping for a COVID-19 vaccine, but most of us won't get it first - Knoxville News Sentinel

LONDON (Reuters) - Britain is ready to roll out tens of millions of COVID-19 vaccines to the public with care-home residents and the elderly first in line for a jab that medics hope will allow the world to return to some semblance of normality.

News that a vaccine from Pfizer and BioNTech was more than 90% effective raised hopes that there may soon be an end to the lockdowns that have cast gloom across the world by shedding millions of jobs and upending normal life.

England's Deputy Chief Medical Officer Jonathan Van-Tam said the country was ready to roll out a vaccine once regulators approved it as safe, quipping that he had told his 78-year-old mother to be ready for a jab.

"Do I think we will then move at pace to keep up with the volumes that are supplied to us? Yes I absolutely do," Van-Tam told reporters, adding that he would love to be at the front of the queue for a vaccine but that high risk individuals should come first.

Van-Tam added that the government would not use any vaccine until the Medicines and Healthcare products Regulatory Agency (MHRA) had approved it.

"There is absolutely no chance that we will compromise on standards of safety or effectiveness," MHRA CEO June Raine said.

Asked if people should be able to jump the queue by buying a vaccine, Van-Tam said that wealth should not be a determinant for getting a vaccine.

"I think these vaccines, need to be prioritised to those who need them, and not those who can afford to pay for them privately," he said.

Britain has ordered a total of 350 million doses of the vaccines in development, including 40 million shots of Pfizer's jab. Trial data from a competing vaccine developed by Oxford University and AstraZeneca is expected in the coming weeks.

"At the very top of our priority list is care home residents and people who work in care homes," said Professor Wei Shen Lim, a member of the Joint Committee on Vaccination and Immunisation which advises the government on immunisation.

Story continues

Lim said that next in line would be those above 60 and then adults with underlying health conditions.

(Reporting by Guy Faulconbridge and Paul Sandle; editing by Sarah Young)

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UK ready to roll out COVID-19 vaccine once regulator gives safety all clear - Yahoo News

NASHVILLE, Tenn. (WTVF) A COVID-19 vaccine could be distributed in Tennessee in just 24 to 48 hours after approval from FDA, a top Tennessee Department of Health official said.

At a media briefing Monday morning, Dr. Lisa Piercey, Commissioner of TDH, said Pfizer's COVID-19 vaccine trial was promising for the state. Piercey was hopeful a vaccine could be ready for distribution this year.

"We know that the only effective way to achieve herd immunity is through an effective vaccine. We got some really good news this morning from Pfizer that their vaccine is shortly to come and that it's highly effective. Even more so than they have initially anticipated," said Dr. Piercey.

She also said there could be statewide distribution within days following the FDA's approval of the vaccine.

"We have been working diligently on a distribution plan," said Piercey. "As soon as we get the word that it's coming we're ready to deploy it."

News of the vaccine comes at a time when COVID-19 cases are reaching peak levels in the state. Dr. Piercey said she believes the spike will eclipse previous increases the state has seen since March.

She suggests caution when going into the holidays gathering with friends and family.

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Tennessee ready to distribute COVID-19 vaccine within 24 to 48 hours of approval by FDA - NewsChannel5.com

[Heres what you need to know about Pfizers Covid-19 Vaccine.]

On Nov. 17-18, DealBook is holding our first Online Summit. Join us as we welcome the most consequential newsmakers in business, policy and culture to explore the pivotal questions of the moment and the future. Watch for free from anywhere in the world. Register now.

The pandemic is still raging, but it would be hard to tell from the ecstatic stock market, which flirted with record highs thanks to promising clinical trial data on a coronavirus vaccine from Pfizer and BioNTech. Futures today suggest that yesterdays rally could be extended.

Hopes that the pandemic will come under control scrambled the usual pattern, with shares soaring for the sectors most linked to growth in the broad economy, like energy and banks, and the companies most affected by lockdowns, like AMC (up 51 percent), United Airlines (up 19 percent) and Macys (up 17 percent). Tech-heavy stars of the pandemic were the days biggest losers, like Peloton (down 20 percent), Zoom (down 17 percent) and Netflix (down 9 percent).

The probability of an L-shaped recovery has been significantly reduced, said Johanna Kyrklund, Schroders chief investment officer. We may finally have found the catalyst to spark a move away from the stay-at-home stocks that have benefited from lockdown, towards recovery stocks.

There are reasons to be wary. Experts cautioned that even if Pfizer wins approval for its vaccine and itll need much more data doses will be initially available to only a small sliver of the population. As our colleagues at The Morning newsletter note, there are two very different coronavirus stories happening now: While the markets are rejoicing, records for coronavirus infections are being set daily.

The key question: Are investors getting ahead of themselves? These are the types of moves that tend to run out of gas if the underlying data doesnt quickly confirm the enthusiasm, Lisa Shalett, chief investment officer at Morgan Stanley Wealth Management, told The Times. The sharp turns call into question the efficiency of supposedly all-knowing markets, as the Deal Professor notes below.

Europe charges Amazon with antitrust violations. The E.U.s competition chief, Margrethe Vestager, accused the e-commerce giant of exploiting data it collects from third-party merchants to boost its own sales. We must ensure that dual-role platforms with market power, such as Amazon, do not distort competition, she said.

Most Republicans back President Trumps refusal to concede. Officials like Senator Mitch McConnell, the majority leader, declined to rebut Mr. Trumps false claims of illegal votes and a stolen election. Separately, lawyers at Jones Day and Porter Wright, two big law firms working on Mr. Trumps legal challenges, have voiced concerns about their work.

Top SoftBank executives resign as directors. Three senior managers including Rajeev Misra, the head of the Vision Fund, and Marcelo Claure, the companys C.O.O. are stepping down from the board, amid pressure to improve SoftBanks corporate governance. (Theyll stay as executives.)

The E.U. imposes new tariffs on American goods. The $4 billion in levies, on products like aircraft and chocolate, follow a W.T.O. ruling allowing the bloc to retaliate against the U.S. over illegal subsidies to Boeing. The U.S. imposed tariffs on European goods last year after a similar ruling about Airbus.

Bill Grosss property fight with his neighbor heads to court. A trial over competing harassment claims by the famed bond investor and the entrepreneur Mark Towfiq began yesterday. Mr. Gross reportedly said he would stop blaring the Gilligans Island theme song if the neighbor dropped his complaint; a lawyer for Mr. Gross accused Mr. Towfiq of being a peeping Tom.

Steven Davidoff Solomon, a.k.a. the Deal Professor, is a professor at the U.C. Berkeley School of Law and the faculty co-director at the Berkeley Center for Law, Business and the Economy.

Recent weeks havent been good for the efficient markets hypothesis. First, the pollsters got the election wrong, failing to forecast the results for many of last weeks contests. Then, yesterday, investors got the markets wrong.

The burst upward in stocks was aided by the thesis that the calmness of a post-Trump era and divided government would be a boon to business. But make no mistake: Most of the rise was related to Pfizers vaccine news.

Whats so surprising about the rise is that it shouldnt have happened. This vaccine announcement was completely expected. Pfizer and other companies developing vaccines have been signaling a November announcement for weeks. And, in fact, some market observers have been factoring this into their advice on positioning.

Marko Kolanovic, the head of macro quantitative and derivatives strategy at JPMorgan Chase, has been right all year. He called the market bottom, then called the Nasdaq high as well as the turn to consumer cyclicals. He also put out a series of reports leading up to the election noting that evidence beyond the polls suggested President Trump would do better than expected.

Mr. Kolanovics forecasts show what were missing, despite being able to access more information than ever. People are driven by fear, live in the moment and get distracted by a deluge of extreme views on social media. This has been compounded by political bias which infects everything, including assessments of the markets. Trading is consumed by momentum plays and the Robinhood crowd. People have too much information and take longer to process meaningful signals.

All of this is to say that markets may still be efficient in the long term, but these days it takes even longer for this to become clear.

Rich Handler, the C.E.O. of Jefferies, in 20 Things I Wish Someone Told Me The Day I Started My Career As An Analyst On Wall Street

The Affordable Care Act is up for debate at the Supreme Court today. If the law is invalidated, some investors have prepared for refunds on past investment income. Indeed, the litigation has generated a flurry of queries and I.R.S. protective refund claims, tax experts say.

Todays arguments are about Obamacares individual mandate, a penalty for not taking out health insurance. Challengers say that when Congress set the penalty at zero in 2017, they broke the justification given for the entire law in a previous Supreme Court ruling, which depended on treating the mandate as a tax. Theoretically, if Texas and other Republican-leaning states backed by the federal government succeed in striking down the law, refunds could be available on other taxes associated with the A.C.A.

The I.R.S. cited the case in guidance on protective refund claims earlier this year. These claims are placeholders, reserving the right to file after deadline, depending on a future event like litigation. Some filers hope that other taxes will be invalidated if the A.C.A. is struck down, including a 3.8 percent hike on net income investment passed in a 2010 companion law.

Its a long shot. Even if the individual mandate falls, the court may preserve the health care law, and even the whole law falling wouldnt guarantee some of these refunds. Because arguments for unconstitutionality of the mandate depend on a change in law that was enacted in 2017 and did not take effect until 2019, it seems very unlikely that the court will hold that the A.C.A. was invalid as far back as 2016, Jonathan Gifford, a tax attorney at Cleary Gottlieb, told DealBook. But people filing protective refund claims presumably are thinking that anything can happen, and in 2020 that certainly seems truer than ever.

The Timess Brooks Barnes writes from Los Angeles: Months after his blink-and-you-missed it tenure as TikToks C.E.O., Kevin Mayer has taken on a new role: senior adviser to Len Blavatniks Access Industries.

He will bring invaluable knowledge and insight to Access, which owns media businesses like Warner Music and the sports streaming service DAZN, Mr. Blavatnik said. Before joining TikTok, Mr. Mayer led Disney+ and had been a contender to succeed Bob Iger as Disneys C.E.O. President Trumps pressure on TikToks Chinese owners curtailed the networks global ambitions, prompting Mr. Mayer to leave after just three months.

Mr. Mayer called the Access role a key component of my future endeavors. He has also held talks to join Redbird Capital, the sports and entertainment investment firm that recently launched a SPAC.

Travel is down, but when it returns it will be a little easier to get to the airport, a meeting or anywhere else at a set time. Later today, Uber will announce a feature that the business community has long wanted: reservations.

How it works. Through Uber Reserve, riders can schedule trips up to 30 days in advance in more than 20 U.S. cities. The program, which launches next week, will present its fare upfront, as usual. If a pickup doesnt arrive on time, riders get a $50 credit.

Its a swipe at legacy car services. The new program challenges the biggest advantage that car and limo services had over on-demand ride-hailing. But it may take some time to see any impact, given how little people are moving around these days.

Deals

NextEra Energy reportedly offered to buy a rival power utility, Evergy, for $15 billion in stock, months after being rebuffed by Duke Energy. (Reuters)

VF Corporation, which owns Vans and Timberland, will buy the buzzy streetwear brand Supreme for $2.1 billion. (NYT)

Politics and policy

Renewing the Feds emergency loan programs, which are set to expire at the end of the year, has become a bitter political fight. (NYT)

Britain will require big companies to report on climate risks. (Guardian)

Tech

President-elect Joe Biden is expected to continue the Justice Departments antitrust lawsuit against Google and may file competition cases against Facebook, Amazon and Apple. (NYT)

Zoom agreed to third-party audits of its security protocols as part of a proposed settlement with the Federal Trade Commission. (Protocol)

Best of the rest

Since President Trump took office, corporate America has been thrust into the culture wars like never before. (NYT)

Four Seasons the landscaping company, not the hotel is capitalizing on its unexpected role in the Trump campaigns legal challenges, selling shirts with slogans like Lawn and Order! (NYT)

Wed like your feedback! Please email thoughts and suggestions to dealbook@nytimes.com.

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Are Markets Overexcited About Pfizer's Covid-19 Vaccine News? - The New York Times

Pfizer Inc. said Monday that its COVID-19 vaccine may be a remarkable 90% effective, based on early and incomplete test results that nevertheless brought a big burst of optimism to a world desperate for the means to finally bring the catastrophic outbreak under control.

The announcement came less than a week after an election seen as a referendum on President Donald Trumps handling of the scourge, which has killed more than 1.2 million people worldwide, including almost a quarter-million in the United States alone.

Were in a position potentially to be able to offer some hope, Dr. Bill Gruber, Pfizers senior vice president of clinical development, told The Associated Press. Were very encouraged.

Pfizer, which is developing the vaccine with its German partner BioNTech, now is on track to apply later this month for emergency-use approval from the U.S. Food and Drug Administration, once it has the necessary safety information in hand.

Even if all goes well, authorities have stressed it is unlikely any vaccine will arrive much before the end of the year, and the limited initial supplies will be rationed.

Dr. Anthony Fauci, the U.S. governments top infectious-disease expert, said the results suggesting 90% effectiveness are just extraordinary, adding: Not very many people expected it would be as high as that.

Its going to have a major impact on everything we do with respect to COVID, Fauci said as Pfizer appeared to take the lead in the all-out global race by pharmaceutical companies and various countries to develop a well-tested vaccine against the virus.

Dr. Bruce Aylward, the World Health Organizations senior adviser, said Pfizers vaccine could fundamentally change the direction of this crisis by March, when the U.N. agency hopes to start vaccinating high-risk groups.

Global markets, already buoyed by the victory of President-elect Joe Biden, rallied on the news from Pfizer. The S&P 500 finished the day with a gain of 1.2%, while the Dow Jones Industrial Average rose more than 800 points. Pfizer stock was up more than 8%.

Still, Mondays announcement doesnt mean for certain that a vaccine is imminent: This interim analysis, from an independent data monitoring board, looked at 94 infections recorded so far in a study that has enrolled nearly 44,000 people in the U.S. and five other countries.

Some participants got the vaccine, while others got dummy shots. Pfizer released no specific breakdowns, but for the vaccine to be 90% effective, nearly all the infections must have occurred in placebo recipients. The study is continuing, and Pfizer cautioned that the protection rate might change as more COVID-19 cases are added to the calculations.

Dr. Jesse Goodman of Georgetown University, former chief of the FDAs vaccine division, called the partial results extremely promising but ticked off many questions still to be answered, including how long the vaccines effects last and whether it protects older people as well as younger ones.

Trump, who had suggested repeatedly during the presidential campaign that a vaccine could be ready by Election Day, tweeted: STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!

Biden, for his part, welcomed the news but cautioned that it could be many months before vaccinations become widespread in the U.S., and he warned Americans to rely on masks and social distancing in the meantime. He said the country still faces a dark winter.

Confirmed infections in the U.S. eclipsed 10 million on Monday, the highest in the world. New cases are running at all-time highs of more than 100,000 per day. And tens of thousands more deaths are feared in the coming months, with the onset of cold weather and the holidays.

Pfizers vaccine is among four candidates already in huge studies in the U.S., with still more being tested in other countries. Another U.S. company, Moderna Inc., also hopes to file an application with the FDA late this month.

Both companies shots are made with a brand-new technology. These mRNA vaccines arent made with the coronavirus itself, meaning theres no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.

Despite cheering the news early on Monday, Trump posted a series of tweets later Monday accusing Pfizer and the U.S. Food and Drug Administration of waiting until after the election to announce its positive vaccine news for political reasons.

Pfizer has insisted that its work is not influenced by politics and that it was moving at the speed of science. The company itself learned of the interim results on Sunday after its independent data monitors met to discuss them. The FDA was not involved in Pfizers decision to announce its early results and did not make any announcements of its own.

Pfizer initially opted not to join the Trump administrations Operation Warp Speed, which helped fund a half-dozen vaccine makers research and manufacturing scale-up. Pfizer instead said it has invested $2 billion of its own money in testing and expanding manufacturing capacity. But in July, Pfizer signed a contract to supply the U.S. with 100 million doses for $1.95 billion, assuming the vaccine is cleared by the FDA.

Pfizer said its only involvement in Operation Warp Speed is that those doses are part of the administrations goal to have 300 million doses of COVID-19 vaccines ready sometime next year.

The strong results were a surprise. Scientists have warned for months that any COVID-19 shot may be only as good as flu vaccines, which are about 50% effective and require yearly immunizations. Earlier this year, Fauci said he would be happy with a COVID-19 vaccine that was 60% effective.

Whatever the ultimate level of protection, no one knows if people will need regular vaccinations.

Also, volunteers in the study received a coronavirus test only if they developed symptoms, leaving unanswered whether vaccinated people could get infected but show no symptoms and unknowingly spread the virus.

Pfizer has estimated it could have 50 million doses available globally by the end of 2020, enough for 25 million people.

Public Citizen, the consumer advocacy group, called the release of the preliminary and incomplete data bad science and said that any enthusiasm over the results must be tempered until they are reviewed by the FDA and its independent experts.

Crucial information absent from the companies announcement is any evidence that the vaccine prevents serious COVID-19 cases or reduces hospitalizations and deaths due to the disease, the organization said.

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AP writers Marilynn Marchione, Frank Jordans and Charles Sheehan contributed to this report.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education. The AP is solely responsible for all content.

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Pfizer says COVID-19 vaccine is looking 90% effective - The Associated Press

Gen. Gustave Perna tells NPR that if a safe and effective COVID-19 vaccine is approved by the Food and Drug Administration in December, "10 to 30 million doses of vaccine will be available that we can start distributing" in the United States. Chip Somodevilla/AP hide caption

Gen. Gustave Perna tells NPR that if a safe and effective COVID-19 vaccine is approved by the Food and Drug Administration in December, "10 to 30 million doses of vaccine will be available that we can start distributing" in the United States.

A top U.S. Army general who is co-leading the federal COVID-19 vaccine initiative anticipates that the first of millions of Americans could start receiving COVID-19 vaccines as soon as next month.

"I think a safe and effective vaccine will be available initially in December," Gen. Gustave Perna told NPR's Mary Louise Kelly in an interview Monday. If the Food and Drug Administration authorizes a vaccine by then, "10 to 30 million doses of vaccine will be available that we can start distributing."

Perna is chief operating officer for Operation Warp Speed, the government's initiative to fast-track the development, manufacture and distribution of COVID-19 drugs and treatments. In May, he was appointed to co-lead the project, along with the initiative's chief science adviser, Moncef Slaoui.

Perna's remarks followed an announcement earlier Monday of promising developments about a COVID-19 vaccine developed by the drug company Pfizer. Early results suggest that the vaccine is more than 90% effective in preventing COVID-19. "Great [news] to wake up to today," he said.

"When we talk 'vaccine effectiveness,' what we're talking about is, 'How effective was the vaccine at preventing actual disease?' " scientist L.J. Tan, chief strategist of the nonprofit Immunization Action Coalition, explained to NPR's Allison Aubrey in September.

In other words, by that definition, if you vaccinated 100 people, at least 90 people would not get the disease, if these early results from Pfizer hold up.

The tens of millions of vaccine doses that Perna says could be available in December is the combined number of vaccine doses that Pfizer and Moderna, manufacturers of the two candidates furthest along in clinical trials, could have ready to ship by then.

Being prepared to have large quantities of the COVID-19 candidate vaccines ready for distribution as soon as one is authorized as safe and effective by the FDA has been a major feat of planning and coordination that runs counter to the typical drug and vaccine development process.

"Generally, you don't start manufacturing a vaccine until you have an [approval]," Perna explains. But waiting for an OK from the FDA before ramping up production would have greatly prolonged the timeline for getting a COVID-19 vaccine out to the public.

So early on, the Operation Warp Speed team invested in manufacturing capacity. "We needed brick and mortar," Perna says. "We needed trained employees. We needed to have all the materials, and we needed very technical machinery to produce the vaccine."

"We started executing manufacturing requirements in parallel with the development and the trials of the vaccines," he says.

Simultaneously pursuing processes that typically happen one after another is a resource-intensive, high-risk strategy. It's possible that some pre-manufactured vaccine candidates will not be found to be safe or effective and that those vials would need to be thrown out. But the strategy makes it possible for some vaccine doses to be available as soon as a vaccine is authorized and for vaccine production to scale up quickly after that.

If a vaccine is in hand in December, availability "will expand rapidly in January, February, March, April," Perna told NPR, describing a "steady cadence" of vaccine rollout that could result in most Americans getting access to a shot by mid-2021.

A four-star general, Perna previously served as the commanding general for the U.S. Army Materiel Command, which manages the Army's global supply chain. "I'm a professional logistician. That's what I've been doing for 39 years," he says.

The military is coordinating the vaccine distribution but will not play a direct role in moving or injecting vaccines on the ground, according to Perna. "We're partnering with commercial industry to do the actual distribution, because they know how to do it," he says, "They do it every year, with influenza and other medications and vaccines."

Pfizer has an assembly center in Kalamazoo, Mich., and plans to use private carriers such as UPS and FedEx to deliver vaccines to hospitals and vaccination sites. Vaccines from Moderna and other Operation Warp Speed candidate vaccines would likely be moved by the medical supply company McKesson, which has a contract with the government to distribute COVID-19 vaccines.

The government will be allocating initial vaccine supplies to states and jurisdictions, which will then be responsible for getting shots into people's arms and determining which groups get priority for those first doses. "Some of the jurisdictions have thought about mass [vaccination] campaigns. Some are going right to brick-and-mortar and working with CVS and Walgreens. Some are going to utilize their hospitals," and the places people can go to get vaccines may shift as more doses become available, Perna says.

Perna says he hasn't heard from President-elect Joe Biden's transition team yet but played down suggestions that a change in administration could complicate the work. "I believe that the mission we have to develop, manufacture and deliver safe and effective vaccines is moving in the right direction," Perna says. "And I am just going to keep my head down and drive to that and keep going."

From Delaware, Biden met with his newly formed COVID-19 advisory board Monday morning. In remarks after the meeting, he warned Americans to brace for "a very dark winter," despite the good news that Pfizer's vaccine seems to be effective, pending further tests.

"The projections still indicate we could lose 200,000 more lives in the coming months before a vaccine can be made widely available," Biden said, imploring Americans to wear face masks in public. Until nearly everyone has been vaccinated, he said, "a mask remains the most potent weapon against the virus."

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A COVID-19 Vaccine Could Begin Deployment In US In December, If FDA-Approved : Shots - Health News - NPR