Pfizer could have 50 million coronavirus vaccine doses manufactured by years end – The CT Mirror

Pfizer could have 50 million coronavirus vaccine doses manufactured by years end – The CT Mirror

Italy, Covid-19, Trump: Your Wednesday Briefing – The New York Times

Italy, Covid-19, Trump: Your Wednesday Briefing – The New York Times

November 11, 2020

(Want to get this briefing by email? Heres the sign-up.)

Good morning.

Were covering new lockdown measures for Italy, what President Trumps defeat means for populism, and Denmarks mink cull.

As a second wave of the coronavirus pandemic strains the Italian health care system, the government will seal off and lock down hard-hit portions of the country today, limiting movement to and between areas in at least five regions.

As of Monday, the average number of daily new cases over seven days was 32,684, according to a New York Times database, a 92 percent increase from 14 days prior. Hospitals have had to make room for beds in chapels and conference rooms as coronavirus patients overwhelm wards.

Nearly all the Italian regions are highly affected, said Giovanni Rezza, the director of the prevention department at the Health Ministry, adding that new restrictions were necessary in a situation that keeps worsening.

Unrest: Protests by regional presidents in the locked-down areas have unnerved the government. Do we get it or not that we are at war? said Pierpaolo Sileri, Italys deputy health minister. We are fighting to save Italy.

Here are the latest updates and maps of the pandemic.

In other developments:

Saeb Erekat, a senior Palestinian negotiator who passionately advocated the establishment of an independent Palestinian state, has died after contracting Covid-19. He was 65.

U.S. federal health officials provided projections for when and how Americans might be able to begin to receive a Covid-19 vaccine, once one has been authorized.

Lockdown something experienced, dreaded and needed by much of the world for at least some of 2020 is the Collins English Dictionarys word of the year.

A husband-and-wife team helms the European biotech start-up working with Pfizer on its leading vaccine. (On their wedding day, they returned to the lab after the ceremony.)

President-elect Joe Bidens victory in the U.S. presidential election last week is a stinging blow to right-wing populists, from Britain and Brazil to Poland and Hungary. But its consequences for populism as a global political movement are more ambiguous.

Whether the fortunes of comparable politicians in Europe will be tied to President Trumps remains to be seen, analysts say. The economic, social and political grievances behind such movements are still alive and indeed may be reinforced by the ravages of the coronavirus pandemic, while social media continues to spread populist ideas, often cloaked in conspiracy theories.

In a signal of a broader return to normal in international relations, Mr. Biden fielded congratulatory calls from European leaders such as President Emmanuel Macron of France and Chancellor Angela Merkel of Germany on Tuesday. President Vladimir Putin of Russia is among the few authoritarian allies of Mr. Trump to maintain silence about the election, along with President Jair Bolsonaro of Brazil and President Xi Jinping of China.

Across the border: After four years of surprise tariffs, stinging insults and threats from Mr. Trump, many Canadians have expressed giddy jubilation and sense of deep relief over Mr. Bidens victory.

The transfer of power: Asked about Mr. Trumps continuing refusal to concede the election, Mr. Biden said: How can I say this tactfully? It will not help the presidents legacy. A Trump appointee must formally recognize Mr. Biden as the president-elect for the transfer to begin. The Times has found no evidence of voter fraud.

The Upshot: How did pollsters get it so wrong again? For now, there is no easy excuse.

The Netflix hit The Queens Gambit has inspired a new debate about inequality and sexism in chess and what, if anything, can be done about it. Among the more than 1,700 grandmasters worldwide, only 37 are women. Currently, only one woman, Hou Yifan of China, ranks in the Top 100.

The reality, top players and teachers say, is even worse. There were opponents who refused to shake hands, said Judit Polgar, the only woman to ever be ranked in the Top 10 of the game.

Nagorno-Karabakh: Russian peacekeeping forces were deployed to the ethnic Armenian enclave on Tuesday after Armenia and Azerbaijan signed a Russian-brokered deal to end a six-week war that had already killed thousands.

Amazon: European Union regulators charged the tech giant with antitrust violations, saying it was unfairly using data to box out smaller competitors.

Soccer: Greg Clarke, the chairman of Englands soccer association, has resigned from his position after a disastrous testimony to a parliamentary committee in which he spoke in offensive stereotypes about Black and Asian people, girls and others.

Affordable Care Act: At a Supreme Court hearing, at least five justices signaled support for the health care law and suggested that striking down the so-called individual mandate, the requirement to obtain insurance, would not doom the balance of the law.

Snapshot: Emily Harrington, above, is the first woman to free-climb the Golden Gate route up El Capitan, a 3,000-foot-high monolith in Yosemite National Park, in under 24 hours. Her mantra: Slow is smooth, smooth is fast.

Fowl play: A hacker slipped more than 1,500 fake votes into New Zealands Bird of the Year 2020 contest, in favor of the kiwi pukupuku, ruffling the feathers of the countrys online community.

Lives Lived: Marty, the highest cat in New England, was the green-eyed, feather-tailed, much-loved mascot of Mount Washington Observatory, some 6,288 feet above sea level in North Conway, N.H. He died at 14, or possibly 15, last week.

What were reading: This Caity Weaver homage to her home state. Our colleague Daniel Victor, a reporter in London, calls it the Pennsylvania tribute that Pennsylvania deserves.

Now, a break from the news

Cook: These brussels sprouts with pickled shallots and labneh call for date syrup, available at Middle Eastern grocery stores or online, or pekmez, a type of fruit molasses used in Turkish cooking.

Read: These four story collections reconsider history and upend tradition, including Where the Wild Ladies Are by Aoko Matsuda, which updates a traditional Japanese folk tale for our contemporary world.

Do: Decades-old movies, songs and video games are surging in popularity, along with old favorites like Spice Girls and Fleetwood Mac. Nostalgia can be a healthy coping mechanism during the pandemic.

Made plans for tonight? Check out our At Home collection of ideas to help you decide what to read, cook, watch, and do while staying safe at home.

Denmarks mink cull is on hold because of a question about the governments legal authority to order it. But why did it seek to do so in the first place? James Gorman, a science writer at large for The Times, explains what you need to know, excerpted here.

Can mink infect people with the coronavirus?

Yes. In Denmark, mink have contracted the virus and spread it to people. The same happened in the Netherlands this year. They are the only animal known to do so.

Does the virus mutate in mink?

Yes. In more than 200 people, Danish authorities have documented several variants of the virus that contain mutations originating in mink. The virus also mutates in people. But there is no evidence that any of the mutations that originated in mink make the coronavirus more transmissible in humans or make humans sicker.

Why did Denmark decide to kill all of its farmed mink?

Danish health authorities were concerned that one set of mutations could make a potential coronavirus vaccine less effective, after the possibility was raised in preliminary tests. The World Health Organization and independent experts said there was no evidence so far that it would diminish the value of vaccines currently in development.

Did Denmark overreact?

Scientists say that there are reasons beyond this particular mutated virus for Denmark to act.

The crowded conditions of mink farms could put evolutionary pressures on the virus different from those in the human population. The virus could also jump to other animals from mink. These are all worrisome possibilities, particularly in the midst of a resurgence of the virus in the human population.

Thanks for joining me. See you next time.

Natasha

Thank youTo Theodore Kim and Jahaan Singh for the break from the news. You can reach the team at briefing@nytimes.com.

P.S. Were listening to The Daily. Our latest episode is about what went wrong with presidential polling. Heres our Mini Crossword, and a clue: Sound from a baby bird (five letters). You can find all our puzzles here. The word hyperpoop first appeared in The Times on Tuesday, according to the Twitter account @NYT_first_said. Andrew Higgins, our Moscow bureau chief, will be moving to Warsaw to head up our Eastern Europe bureau. Anton Troianovski will be our next Moscow bureau chief.


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Italy, Covid-19, Trump: Your Wednesday Briefing - The New York Times
Restaurants and gyms drove COVID-19 transmission this spring – Livescience.com

Restaurants and gyms drove COVID-19 transmission this spring – Livescience.com

November 11, 2020

Restaurants, cafes, and gyms acted as "superspreading" sites for COVID-19 transmission last spring, accounting for the majority of new infections in large U.S. cities, according to a new study.

The findings, published today (Nov. 10) in the journal Nature, also suggest that reducing maximum occupancy at these venues may be more effective for curbing COVID-19 spread than blanket lockdowns, the authors said.

"Our work highlights that it does not have to be all or nothing," study senior author, Jure Leskovec, a computer scientist at Stanford University, told The New York Times.

Related: 14 coronavirus myths busted by science

The study researchers created a model to mimic the spread of COVID-19 in 10 major U.S. cities: New York, Los Angeles, Chicago, Dallas, Washington, D.C., Houston, Atlanta, Miami, Philadelphia and San Francisco. The model not only took into account standard factors in the spread of an infectious disease (such as how many people are susceptible, exposed, infected and immune to the virus), but also drew on real data that showed how often people came into close contact with others. To do so, they incorporated information on people's behavior using anonymized cellphone data from 98 millions Americans, tracking their movements from their neighborhoods to about 553,000 public locations between March 1 and May 2. They also obtained the square footage of these venues to calculate the number of people per square foot in each of these locations at a given time. .

They found that their model could accurately predict daily COVID-19 case counts in these cities.

The researchers then estimated the number of infections that occurred at each of the public locations, and found that the majority of infections occurred at just a small number of "superspreading" venues. For example, in Chicago, 10% of venus accounted for 85% of the predicted infections, the authors found.

What's more, when the researchers modeled the risk of reopening venues after lockdowns, some venues particularly restaurants posed a much higher risk than others in terms of the number of new infections that would occur upon reopening.

"Restaurants were by far the riskiest places, about four times riskier than gyms and coffee shops, followed by hotels," Leskovec said in a news conference, according to the Times. The researchers hypothesized these venus were more risky because they tended to have a high density of people who stayed for long periods.

Some of the less risky venues including car dealerships, gas stations and hardware stores, the study found.

Overall, the researchers found that limiting venue occupancy to 20% of maximum capacity reduced predicted infections by more than 80%, while only reducing overall visits to these venues by 42%.

The study findings also help explain why minority and low-income populations have been hit particularly hard by COVID-19.

During lockdowns, people in lower-income neighborhoods did not reduce their mobility as much as those in more affluent neighborhoods, likely because they had jobs that did not allow them to work from home. In addition, venues such as grocery stores in lower-income areas had higher COVID-19 transmission rates because these venues were smaller and more crowded, and people stayed there longer, compared with similar venues in more affluent areas, the study found.

These findings suggest ways for policymakers to reduce disparities in COVID-19 infection rates, for example, with occupancy caps to reduce crowding, in addition to improved paid leave policies so workers can stay home when sick, the authors said.

"Our results suggest that infection disparities are not the unavoidable consequence of factors that are difficult to address in the short term, like differences in preexisting conditions; on the contrary, short-term policy decisions can substantially affect infection outcomes by altering the overall amount of mobility allowed and the types of [venues] reopened," the authors said.

The authors note their model did not include all public locations, in particular it did not include schools or offices. In addition, because the study used data from the beginning of the pandemic, the findings do not necessarily apply to COVID-19 transmission today. For example, people are more likely to practice social distancing and wear masks at restaurants today compared with March. And health officials have noted that many new outbreaks in the U.S. are being driven by small gatherings in people's homes.

Still, the researchers hope their findings can be used by policymakers to help guide reopenings. They are currently working on a tool to make their model accessible for policymakers and public health officials.

Originally published on Live Science.


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Restaurants and gyms drove COVID-19 transmission this spring - Livescience.com
Study aims to reduce HPV and COVID-19 vaccine hesitancy among teens in rural Alabama – The Mix

Study aims to reduce HPV and COVID-19 vaccine hesitancy among teens in rural Alabama – The Mix

November 11, 2020

Investigators are developing a telemedicine program to reduce vaccine hesitancy related to HPV and the novel coronavirus for adolescents in rural Alabama.

Henna Budhwani, Ph.D., a medical sociologist and an assistant professor at the UAB School of Public HealthNationally, nearly half of adolescents are up to date on their human papillomavirus vaccines. However, in Alabama, only 20 percent of adolescents have received all doses of this vaccine. Moreover, in some of the states rural counties, HPV vaccination rates are as low as 9 percent.

Identifying ways to encourage adolescents in rural communities to learn about and accept FDA-approved vaccines is the focus of a new study led by a researcher at the University of Alabama at Birmingham.

Henna Budhwani, Ph.D., a medical sociologist and an assistant professor at the UAB School of Public Health, has received a $300,000 grant from Merck, Sharp and Dohme, Corp. The money will be used to develop and test the feasibility and acceptability of a telemedicine (mHealth) intervention, to reduce vaccine hesitancy by increasing vaccine education and promote teens autonomy for their own health.

Reducing vaccine hesitancy in the rural Deep South is a high-priority public health target, Budhwani said. Focusing on increasing HPV vaccine awareness and understanding the causes of COVID-19 vaccine hesitancy are urgently warranted, due to low rates of HPV vaccine that lead to high rates of preventable cancers, and high rates of COVID-19 that disproportionately affect African American populations.

Budhwani and Tina Simpson, M.D., the studys co-principal investigator and a professor in the Department of Pediatrics at UAB, are creating this mHealth intervention.

Adolescents in these rural communities are clinically underserved, and their parents may not know about the HPV vaccine or their childs risk for developing cervical or oropharyngeal cancers, Budhwani explained. The few providers that work in rural communities are often so overburdened providing first-line care that they may not even offer the HPV vaccine.

As part of this project, Budhwani and Simpson will conduct interviews with adolescents and their parents to better understand vaccine hesitancy related to COVID-19; this will enable Budhwani and Simpson to prepare high-impact messaging to spread information about the novel coronavirus vaccine when it becomes available.

African American communities are disproportionately affected by COVID-19, and the same reasons underlying vaccine hesitancy related to the HPV vaccine have the potential to negatively influence the acceptance, uptake and confidence in a new novel coronavirus vaccine, Budhwani said. We anticipate that, through our study, we will improve participants knowledge of HPV and COVID-19, increase their understanding of the importance of vaccinations, and reduce stigmas associated with vaccination, COVID-19, HPV and cervical cancer.

The study will begin in early 2021.


See the original post here: Study aims to reduce HPV and COVID-19 vaccine hesitancy among teens in rural Alabama - The Mix
A COVID-19 Vaccine Could Begin Deployment In US In December, If FDA-Approved : Shots – Health News – NPR

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

November 10, 2020

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

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

November 10, 2020

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.

___

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

___

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.


More: Pfizer says COVID-19 vaccine is looking 90% effective - The Associated Press
‘I’ve never worked harder’: the race to develop a COVID-19 vaccine – Nature.com
Novavax COVID-19 vaccine is on the fast track by FDA | TheHill – The Hill

Novavax COVID-19 vaccine is on the fast track by FDA | TheHill – The Hill

November 10, 2020

Pharmaceutical company Novavax announced on Monday that it has been granted a fast track designation for its COVID-19 vaccine candidate by the Food and Drug Administration (FDA), according to MarketWatch.

The companys vaccine candidate will be expedited with the help of the government agency in a bid to accelerate the development of an effective and safe COVID-19 vaccine.

Officials at Novavax expect its candidate, called NVXCoV2373, to complete its phase 3 trials based in the U.S. and Mexico by the end of November.

"While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. and globally," Gregory M. Glenn, president of Novavax Research and Development, said in a statement.

This announcement comes on the heels of Pfizer, another COVID-19 vaccine contender, announcing Monday that its efficacy data saw a 90 percent prevention rate for its candidate during phase 3 trials.

Both Novavax and Pfizer have received federal funding as part of Operation Warp Speed, an initiative established by the Trump administration that provided funding to pharmaceutical companies to develop COVID-19 vaccines in a record-breaking time frame.

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Novavax COVID-19 vaccine is on the fast track by FDA | TheHill - The Hill
Pfizer Says Its COVID-19 Vaccine Is More Than 90 Percent Effective and Has Displayed No Side Effects – The Daily Beast

Pfizer Says Its COVID-19 Vaccine Is More Than 90 Percent Effective and Has Displayed No Side Effects – The Daily Beast

November 10, 2020

The drug maker Pfizer announced Monday that its coronavirus vaccine appears to be able to prevent more than 90 percent of people from getting COVID-19a major development that the company has described as a great day for science and humanity. Pfizer, which developed the vaccine with the German drugmaker BioNTech, said its preliminary analysis shows that its vaccine is more than 90 percent effective in preventing the disease, and no serious safety concerns have been observed during tests on 43,500 people in six countries. According to The New York Times, Pfizer now plans to ask the Food and Drug Administration for emergency authorization and said it will have manufactured enough doses to immunize 15 to 20 million people by the end of the year. The Times notes the company released only sparse details from the trial and that long-term safety information was still to be collected.

The Dow Jones Industrial Averages futures index shot up 1500 points on the early morning news.


View post: Pfizer Says Its COVID-19 Vaccine Is More Than 90 Percent Effective and Has Displayed No Side Effects - The Daily Beast
COVID-19 vaccine is glimmer of hope, but doctors say it will take awhile to help – WWMT-TV
How theyll know if the COVID-19 vaccines work is a matter of math, biology  and a little luck – The Philadelphia Inquirer

How theyll know if the COVID-19 vaccines work is a matter of math, biology and a little luck – The Philadelphia Inquirer

November 10, 2020

And this surveillance must continue even after approval, said Penns Ellenberg. If one of the vaccines provokes an unforeseen reaction in, say, 1 out of 10,000 recipients, on average, then it very possibly might not show up in an initial trial group of 15,000 or 20,000 people, she said.


See more here: How theyll know if the COVID-19 vaccines work is a matter of math, biology and a little luck - The Philadelphia Inquirer