Category: Corona Virus Vaccine

By Adam Mossoff

To ensure that coronavirus vaccines and treatments are available at a price affordable to all people, Congresswoman Jan Schakowsky and several other House Democrats recently proposed a radical solution to the coronavirus pandemic commandeer any lifesaving, yet-to-be-created vaccine and allow the government to set reasonable prices.

Although this may sound like it would benefit people, it would be a disaster for patients. Intellectual property protections arent a barrier to care. Just the opposite. Theyre responsible for the most revolutionary medical innovations in human history. And theyre our best hope of ending this pandemic.

Patents enable companies to sell their drugs and licenses to other companies to make those drugs without copycat competition for a limited time. Without such protections, thered be little incentive for private companies and investors to dedicate hundreds of billions of dollars to the scientists at the cutting edge of biomedical research.

The Founding Fathers understood that intellectual property rights were essential to the growth and success of the country, empowering Congress in the Constitution to secure this exclusive right to inventors. They placed the governments power to protect patents on par with creating federal courts, declaring war, and creating an army and navy.

Our early leaders proved prescient. Nearly all of the medical breakthroughs in the past century would have been impossible without reliable and effective IP rights. These include recent developments, such as the antiretroviral therapies that have brought Americas HIV/AIDS death rate down by 80 percent, and the cancer therapies that have cut mortality rates by nearly a quarter since the early 1990s.

After more than a century of continuous breakthroughs, its easy to take this medical progress for granted. But we shouldnt forget that, before IP rights and the free market brought us modern medicine, life was nasty, brutish and short.

People routinely died from diseases that are easily treatable today. Less than a hundred years ago, President Calvin Coolidges 16-year-old son died in 1924 after injuring his toe playing tennis on the White House lawn. Without antibiotics, Calvin Jr. developed a common blood infection that killed him within a week.

We cant let misinformed, misguided politicians bring us back to those days.

America has had the strongest IP protections in the world and as a result, were far more innovative than other nations. The United States accounts for about 5 percent of the worlds population and a quarter of its economic output, but invents two-thirds of all new drugs.

Despite this ingenuity, some public officials still view patents as barriers to healthcare access particularly during public health emergencies like COVID-19.

Others urge the federal government to march in and seize drug patents under the Bayh-Dole Act of 1980. They misunderstand what this law does.

Bayh-Dole only allows the government to seize patents in extremely rare situations, such as when a company is unwilling or unable to sell or license a drug in the healthcare market. Thats not the case right now with COVID-19. In fact, drug companies are racing to turn lab discoveries into real-world treatments. Around 80 clinical trials are already underway for coronavirus drugs and vaccines.

If Congress guts intellectual property protections, biotech firms will hesitate to invest additional money in future research and development projects. Theres no surer way to limit patients access to health care than to undermine IP rights and thus ensure that new medicines are never invented at all.

Adam Mossoff is a patent law expert at Antonin Scalia Law School, George Mason University, and a senior fellow at the Hudson Institute.

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Guest Opinion: Gutting patent protections won't cure COVID-19 - The Coastland Times - The Coastland Times

President Trump on Wednesday rejected the professional scientific conclusions of his own government about the prospects for a widely available coronavirus vaccine and the effectiveness of masks in curbing the spread of the virus as the death toll in the United States from the disease neared 200,000.

In a remarkable display even for him, Mr. Trump publicly slapped down Dr. Robert R. Redfield, the director of the Centers for Disease Control and Prevention, as the president promised that a vaccine could be available in weeks and go immediately to the general public while diminishing the usefulness of wearing masks despite evidence to the contrary.

The presidents comments put him at odds with the C.D.C., the worlds premier public health agency, over the course of a pandemic that he keeps insisting is rounding the corner to an end. Mr. Trump lashed out just hours after Dr. Redfield told a Senate committee that a vaccine would not be widely available until the middle of next year.

I think he made a mistake when he said that, Mr. Trump told reporters. Its just incorrect information. A vaccine would go to the general public immediately, the president insisted, and under no circumstance will it be as late as the doctor said.

Mr. Trump also said Dr. Redfield made a mistake when he told senators that masks were so vital in fighting the disease caused by the coronavirus, Covid-19, that they might be even more important than a vaccine. The mask is not as important as the vaccine, Mr. Trump said.

The president has repeatedly claimed that a vaccine could be available before Election Day on Nov. 3, a timeline that most health experts say is unrealistic, prompting concerns that the Food and Drug Administration might give emergency authorization to a vaccine before it has been fully vetted for safety and effectiveness. Nine pharmaceutical companies have pledged to stand with science and to not push through any product that didnt stand up to scientific scrutiny.

Earlier on Wednesday, Joseph R. Biden Jr., the Democratic presidential nominee, accused the president of trying to rush out a vaccine for electoral gain.

Let me be clear: I trust vaccines, Mr. Biden said. I trust scientists. But I dont trust Donald Trump, and at this moment, the American people cant either.

Michael R. Caputo, the embattled top spokesman of the cabinet department overseeing the U.S. coronavirus response, will take a leave of absence to focus on his health and the well-being of his family, the Department of Health and Human Services announced Wednesday.

Mr. Caputos science adviser, Dr. Paul Alexander, will be leaving the department.

The announcement came after a bizarre and inflammatory outburst on Facebook on Sept. 13 and disclosures that Mr. Caputo and his team had tried to water down official reports of the Centers for Disease Control and Prevention about the pandemic.

Mr. Caputo, a longtime Trump loyalist and the health departments assistant secretary of public affairs, apologized for his Facebook presentation to his staff and to Alex M. Azar II, the departments leader, after his comments became public.

Since he was installed at the department in April by the White House, Mr. Caputo, a former Trump campaign aide, has aggressively worked to develop a media strategy for dealing with the pandemic. But critics, including some in the administration, complained that he was promoting the presidents political interests over public health.

His Facebook talk, which was shared with The New York Times, was filled with ominous predictions of left-wing hit squads plotting armed insurrection after the election and attacks on C.D.C. scientists, who he said had formed a resistance unit determined to undercut Mr. Trumps chances of re-election. He accused the scientists of rotten science and said they havent gotten out of their sweatpants except to plot against the president at coffee shops.

In his appearance in front of a Senate health panel on Wednesday, Dr. Robert R. Redfield, the director of the C.D.C., said Mr. Caputos remarks about government scientists committing sedition were false accusations offensive to career officials at his agency.

C.D.C. is made up of thousands of dedicated men and women, highly competent, Dr. Redfield said. It is the premier public health agency in the world.

Mr. Caputo and a colleague pushed the C.D.C. to delay and edit apolitical . health bulletins, called Morbidity and Mortality Weekly Reports, in an effort to paint the administrations pandemic response in a more positive light.

South Africa will reopen its borders to most countries on Oct. 1, President Cyril Ramaphosa said Wednesday, as the country prepares to ease other restrictions with its virus situation continuing to improve.

We have withstood the coronavirus storm, the president said in a national address.

It is time to move to what will become our new normal for as long as the coronavirus is with us.

Business and leisure travelers entering South Africa, which closed to international passengers in March, will need to present a negative coronavirus test from within 72 hours of their departure or stay in quarantine at their own expense. Anyone showing symptoms will be quarantined until proved to be negative. Mr. Ramaphosa said the government would publish a list of countries with high infection rates that may be subject to travel restrictions.

South Africa will also drop to its lowest alert level starting at midnight this Sunday, allowing for indoor gatherings of up to 250 people and outdoor gatherings of up to 500, with gyms, theaters and other venues limited to 50 percent of their capacity. The nightly curfew will also be reduced to between midnight and 4 a.m. Restrictions on sporting events will remain in place, and masks will still be required in public.

By any measure, we are still in the midst of a deadly epidemic, Mr. Ramaphosa said. Our greatest challenge now and our most important task is to ensure that we do not experience a new surge in infections.

South Africa, the epicenter of the outbreak in Africa and a major tourist destination, went into a strict nationwide lockdown in March that included an unpopular ban on cigarette and alcohol sales. In his speech on Wednesday, Mr. Ramaphosa noted the scourge of violence against women and children during lockdown as well as widespread allegations of corruption related to pandemic relief efforts.

South Africa has had more than 653,000 cases and 15,705 deaths, according to a New York Times database. But the countrys health minister, Dr. Zweli Mkhize, estimated this week that more than a fifth of the population, or 12 million people, had probably been infected.

In other developments around the world:

India reported 97,894 new coronavirus infections on Thursday, its highest one-day increase. The country has the worlds second-highest number of cases after the United States, according to a New York Times database.

New Zealand has entered its first recession in a decade, economic data showed Thursday. Officials said the economy shrank 12.2 percent in the second quarter, the countrys biggest fall on record, amid a nationwide lockdown this spring. On Thursday, the country reported zero community cases for the third consecutive day.

A small group of wealthy nations has bought more than half of the expected supply of the most promising coronavirus vaccines, the British charity group Oxfam said Thursday. Supply deals have been announced for 5.3 billion doses of five vaccines in the last stage of clinical trials. More than 2.7 billion doses, or 51 percent, have been bought by countries including Australia, Britain, Israel, Japan, Switzerland and the United States as well as the European Union, which together represent about 13 percent of the worlds population. Even if all five vaccines are approved, their combined production capacity of six billion doses is enough for only about three billion people since each person is likely to need two doses. That means that nearly two-thirds of the worlds population would not have a vaccine until at least 2022, Oxfam said.

A health official from Madrids regional government warned that the capital was preparing to impose selective lockdowns in districts where the number of cases has recently risen significantly. The minister, Antonio Zapatero, said that the region urgently needed to flatten the curve, before the arrival of colder weather that could help spread the virus faster.

Gen. Eduardo Pazuello on Wednesday became the third health minister in Brazil during the pandemic, The Associated Press reported, after nearly four months holding the position on an interim basis and almost 120,000 deaths from the virus there during that time. General Pazuello, a logistics expert with no prior health experience before taking a deputy position in May, follows two predecessors who departed after disagreements with President Jair Bolsonaro regarding ways to combat the virus.

Six months after locking down the country to curb the spread of the virus, Nepal is starting to welcome back trekkers and mountaineers. The decision is aimed at reviving the countrys ailing economy, which is heavily dependent on mountain tourism. Trekkers visiting Nepal will be required to produce documentation showing that they tested negative before flying in, and to quarantine before traveling to tourist destinations.

A day after covering a large White House event during which many attendees did not wear masks, Israeli reporters returning home on Wednesday were sent into quarantine.

In a statement, a spokesman for Israels Ministry of Health said the journalists who were flying with Prime Minister Benjamin Netanyahu of Israel were directed to go into quarantine and would be the subjects of an epidemiological investigation.

The reporters, who attended Tuesdays signing ceremony on the South Lawn for agreements to normalize relations between Israel and the United Arab Emirates and Bahrain, followed strict health protocols. An Israeli government official said the decision to quarantine them did not result from any specific notice of cases at the White House.

But Health Ministry officials watching the ceremony back in Israel which featured hundreds of attendees, many of them maskless, sitting and mingling in close quarters believed it to be obviously unsafe and were pissed, according to an Israeli government official.

One Israeli reporter who attended the event posted a video on Twitter showing Secretary of State Mike Pompeo speaking just inches away from Israels Mossad chief, Yossi Cohen. Neither man wore a mask.

A day after the ceremony, a Trump administration official tested at the White House was confirmed positive for the coronavirus. The official, who was not publicly identified, was not present for the ceremony, and the authorities began tracing the persons contacts to try to stop any further spread.

The number of cases in Israel, when adjusted for population, has risen to among the highest in the world. The government has mandated a second, nationwide lockdown to begin Friday afternoon, hours before the eve of the Jewish New Year holiday, and to last at least three weeks, extending to the last day of Yom Kippur and the festival Sukkot. The Jerusalem Great Synagogue, the venerable institution where Israeli prime ministers and presidents have prayed, announced on its website on Wednesday that it would remain closed over the Jewish high holidays for the first time in its more than half-century of history.

Connecticut officials on Wednesday took what they called the extraordinary step of closing a nursing home and moving its residents elsewhere after an outbreak that resulted in around 30 cases and four deaths and might have spread to a hospital.

The shutdown came just after the state made the rare move of installing an outside manager at the home, the Three Rivers Nursing Home in Norwich, to address various deficiencies.

The manager recommended the closing after quickly concluding that the problems could not be fixed by Sept. 30 as required by the state, said Deidre S. Gifford, Connecticuts acting health commissioner.

In a statement, the homes operator, JACC Healthcare Center of Norwich, said it supported the move.

Of the homes 53 remaining residents, 17 who have tested positive will be transferred to a home in East Hartford to isolate, officials said; 29 will be moved to other homes near Norwich. The rest are waiting for their test results and under observation for possible infection.

The state began investigating the home last month after 13 residents and two staff members tested positive. By Wednesday, at least 21 residents and six staff members had tested positive.

Investigators found, among other things, inadequate staffing; a failure to keep residents who had tested positive for the virus away from those who had not; and a lack of personal protective equipment.

Investigators also determined that workers at the nursing home had sent several virus patients to Backus Hospital in Norwich for emergency care without telling the hospital in writing that there was an outbreak at Three Rivers. Several hospital employees have tested positive for the virus, and the state is now investigating the outbreak there.

As in many states, the virus has ravaged Connecticuts long-term care homes. Nearly three out of every four of the 3,280 virus-related deaths that the state had recorded as of Wednesday were linked to such homes, according to data compiled by The New York Times.

In neighboring New York, officials this week eased restrictions on visitation guidelines previously set at nursing homes. Under the new rules, homes that have been virus-free for 14 days can allow visitors, half of the previous 28-day requirement.

The Big Ten Conference said Wednesday that it would try to play football as soon as the weekend of Oct. 23, potentially salvaging the seasons of some of the most renowned and lucrative teams in college sports and reversing a decision from just over a month ago not to compete because of the pandemic.

The move will probably appease some prominent coaches, parents, players, fans and even President Trump, but it is also likely to provoke new accusations that the league is prioritizing profits and entertainment over health and safety.

In a statement on Wednesday morning, the league said players, coaches, trainers and others on the field would undergo daily testing for the virus, and that any player who tested positive would be barred from games for at least 21 days.

Leagues that have already returned to play, like the Atlantic Coast Conference and the Big 12, have been forced to postpone a handful of games or bench players because of positive tests or exposure to the virus. Stadiums are operating with fewer spectators in the stands or none at all.

Complicating matters is the association between football and social gatherings like tailgate parties. Health officials near some Big Ten campuses, including Michigan State and Wisconsin, have begun cracking down on students for partying, threatening harsh penalties and putting fraternities and sororities under quarantine. In Ingham County, home to Michigan State University, local health officials ordered residents of nearly two dozen Greek houses, as well as several other group houses, to quarantine for 14 days after the university reported 160 new cases.

While we know many students are doing the right thing, we are still seeing far too many social gatherings in the off-campus community, where individuals are in close contact without face coverings, Mayor Aaron Stephens of East Lansing said on Saturday of the order.

At the University of Wisconsin-Madison, which is also part of the Big Ten and had a sharp uptick in cases last week, local health officials ordered all Greek organizations with one or more cases among their live-in members to quarantine. Several states, including Kansas, Colorado and Michigan, have tracked coronavirus clusters to fraternities and sororities.

And at SUNY Oswego in New York State, which has recorded 70 new cases since Saturday, officials warned students that any parties hosted by fraternity or sorority members, even if not technically sponsored by their Greek organizations, would still lead to severe individual and organizational penalties.

In recent days, the University of Iowa, Iowa State University, Ohio State University and the University of Wisconsin-Madison have canceled spring break, when students often travel to places like Florida and spend a week partying.

In other education news:

The University of Georgia said on Wednesday that it would not be able to host on-campus voting at a student center this fall over concerns about long lines and insufficient indoor air space for social distancing. It said it would provide a shuttle to other voting sites, and that other sites could be made available for in-person voting with the states approval. Critics noted that the universitys football team has not canceled its Oct. 3 season opener, but the university said the game would be held in an outdoor stadium with substantially reduced capacity. In its weekly coronavirus report on Wednesday, the university said a total of 421 positive tests had been reported from Sept. 7 to 13, most of them students, a decline of more than 70 percent from the previous week.

The University of Michigan is seeking a court order to end a strike by graduate students demanding more protection from the virus. In its court filings, the university accused the union, which went on strike Sept. 8, of interfering in the universitys mission to educate students by unlawfully withholding their labor.

All students at the University of Colorado Boulder, which has an enrollment of about 35,000, were advised to quarantine for two weeks by the countys health department on Tuesday after a surge of cases tied to the university. The county health director said that mandatory restrictions would be imposed if the positivity rate remained high.

The University of Arizona, with about 45,000 students, also asked students living on or near campus to quarantine this week and next, with the exception of attending classes, after a major spike in cases. And Grand Valley State Universitys 21,000 students in Allendale, Mich., were also ordered to stay in place for two weeks by the county health department.

President Trump urged Republicans on Wednesday to go for the much higher numbers in stalled negotiations over another economic recovery package, undercutting his partys push for a bare-bones plan that omits another round of stimulus checks for Americans struggling to weather the pandemic-induced recession.

The comments on Twitter were the latest instance in which Mr. Trump has undermined the Republican position in high-stakes negotiations, muddling the partys message along with lawmakers chances of reaching a politically palatable solution.

Democrats are pressing for at least $2.2 trillion in stimulus spending, a sum that White House negotiators and Republican leaders have said is far too high. Senate Republicans tried last week to push through a substantially scaled-back package that would provide only about $300 billion in new spending and did not include the $1,200 stimulus payments but it did not reach the 60-vote threshold and Democrats called the bill inadequate.

In his tweet, the president falsely asserted that it was Democrats who had opposed the stimulus checks which have been a part of every aid plan they have proposed, including the $3.4 trillion measure they pushed through the House in May.

Top Democrats, who are under mounting pressure from centrist lawmakers to act on another relief plan before the November elections, seized on Mr. Trumps comments to try to pressure Republicans to bow to their demands for more spending. Speaker Nancy Pelosi of California and Senator Chuck Schumer, Democrat of New York and the minority leader, said they look forward to hearing from the presidents negotiators that they will finally meet us halfway.

The coronavirus is out of control and is the No. 1 global security threat in our world today, the United Nations secretary general, Antnio Guterres, said Wednesday at a news conference outlining his messages for this years General Assembly session. The session, which began this week, will largely be held via virtual meetings because of the pandemic.

Mr. Guterres called for greater cooperation to develop and distribute an affordable vaccine and criticized what he called deadly misinformation that could dissuade people from getting vaccinated.

Mr. Guterres also said he would press the organizations 193 member states to help ensure that nations heed his plea for a worldwide cease-fire in all armed conflicts, which he called for six months ago to help combat the pandemic.

The United Nations has been unable to orchestrate a coordinated global response to the scourge and its pleas for billions of dollars in emergency aid for the neediest countries have so far only engendered what Mark Lowcock, the organizations top relief official, has called a tepid response.

On Tuesday, the new president of the General Assembly, Volkan Bozkir, a veteran Turkish diplomat, announced he would convene a special session of the body during the first week of November devoted to addressing the pandemic.

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Federal officials outlined details on Wednesday of their preparations to administer a future coronavirus vaccine to Americans, saying that they would begin distribution within 24 hours of any approval or emergency authorization, and that their goal is for no American to pay a single dime out of their own pocket.

The officials, who are part of the governments Operation Warp Speed the multiagency effort to quickly make a coronavirus vaccine available to Americans also said the timing of a vaccine was still unclear.

Were dealing in a world of great uncertainty, said Paul Mango, the deputy chief of staff for policy at the Department of Health and Human Services. We dont know the timing of when well have a vaccine. We dont know the quantities. We dont know the efficacy of those vaccines.

The officials said they were planning for initial distribution of a vaccine perhaps on an emergency basis, and to a limited group of high-priority people such as health care workers in the final three months of this year and into next year. The Defense Department is providing logistical support to plan how the vaccines will be shipped and stored as well as how to keep track of who has gotten the vaccine and whether they have been given one or two doses.

In other science news:

A single infusion of an experimental drug has markedly reduced blood levels of the coronavirus in newly infected patients and lowered the chances that they will need hospitalization, the drugs maker, Eli Lilly, announced on Wednesday. The drug is a monoclonal antibody, a man-made copy of an antibody produced by a patient who recovered from Covid-19.

Russias vaccine, which has been approved by the government but not yet been fully tested for safety and efficacy, won a new customer on Wednesday in India, according to a Russian financial company backing the vaccine. The Indian company, Dr. Reddys Laboratories, agreed first to cooperate on clinical trials and, if they are successful, to buy 100 million doses, the Russian Direct Investment Fund said in a joint statement with the company.

Just hours before New York Citys 1.1 million students logged on for virtual school orientation on Wednesday morning, the Department of Education announced a last-minute change to how children will learn when classes officially start on Monday.

The city announced earlier in the summer that all schools would be required to provide at least some live instruction to all students on every day they were learning at home. Principals and teachers have been warning for weeks that there were simply not enough teachers to educate students in-person and online; different teachers have to instruct each cohort. The city finally acknowledged the enormous staffing crunch, which the principals union estimated could be as large as 10,000 educators, with Tuesday nights announcement.

For students in the hybrid education model, which involves physically attending school one to three days per week and learning remotely the rest of the time, the new rule will no longer require schools to provide daily live instruction when those students are remote. The roughly 40 percent of students who have chosen to learn remotely full time will still get live instruction each day. Students can switch to full remote learning at any time.

When the students in the hybrid model do not receive live instruction, they might instead watch a prerecorded video of a lesson, or complete assignments on their own time. The city also said that if schools have enough staff to provide daily live instruction on days when hybrid students are at home, they should do so.

The citys mayor has argued that reopening schools for in-person instruction is crucial for the citys hundreds of thousands of vulnerable children who were largely failed by remote learning. But the scarcity of both in-person instruction and live teaching has frustrated many parents.

On Wednesday, Mayor Bill de Blasio said that the city would add more teachers throughout the fall to provide live instruction.

Elsewhere in the New York area:

After months of complaints about testing delays, New York City officials are set to announce on Thursday that they have opened a lab in Manhattan that should significantly cut down on wait times as the city prepares for its most ambitious period of reopenings, with public school classes and indoor dining scheduled to begin this month. The new facility will prioritize New York City residents, meaning turnaround times within 24-48 hours, officials said.

Mr. de Blasio on Wednesday announced that he is furloughing his own staff at City Hall, himself included. The policy will affect 495 mayoral staff members, who will have to take an unpaid, weeklong furlough at some point between October and March 2021. The mayor intends to work during his furlough without pay, his spokesman said. The furloughs would yield $860,000 in anticipated savings.

Mr. de Blasio also said on Wednesday that New York City would close off additional streets to vehicle traffic to allow restaurants to serve customers outdoors and would also extend the street closings from weekends to weekdays. The move is meant to try to help restaurant owners offset some of their huge losses during the pandemic. Indoor dining is set to resume in the city on Sept. 30, but restaurants will be allowed to serve at only 25 percent capacity.

Reporting was contributed by Peter Baker, Alan Blinder, Luke Broadwater, Emily Cochrane, Michael Corkery, Michael Crowley, Melissa Eddy, Rick Gladstone, David Halbfinger, Anemona Hartocollis, Mike Ives, Isabel Kershner, Andrew E. Kramer, Gina Kolata, Sapna Maheshwari, Patricia Mazzei, Raphael Minder, Benjamin Mueller, Richard C. Paddock, Linda Qiu, Gretchen Reynolds, Dana Rubinstein, Ed Shanahan, Eliza Shapiro, Bhadra Shrama, Sheryl Gay Stolberg, Glenn Thrush, Marc Tracy, Noah Weiland and Sameer Yasir.

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Live Covid-19 Tracker - The New York Times

Pfizer's coronavirus vaccine could be distributed to Americans before the end of the year if found to be safe and effective,CEOAlbert Bourla said Sunday.

The drugmaker should have key data from its late-stage trial for the Food and Drug Administration by the end of October,Bourla said during an interview on CBS'"Face the Nation." If the FDA approves the vaccine, the company is prepared to distribute "hundreds of thousands of doses," he said.

Because of the pandemic, U.S. health officials and drugmakers have been accelerating the development of vaccine candidates by investing in multiple stages of research even though doing so could be for naught if the vaccine ends up not being effective or safe.

The U.S. pharmaceutical giant has been working alongside German drugmaker BioNTech. In July,the U.S. government announced it would pay the companies $1.95 billion to produce and deliver 100 million doses of their vaccine if it proves safe and effective.The deal was signed as part of Operation Warp Speed, the Trump administration's effort to accelerate development and production of vaccines and treatments to fight the coronavirus.

Bourla said Sunday that the company has already invested $1.5 billion for the development of the potential vaccine. He said if the vaccine failed to work it would be financially "painful" for the company.

"At the end of the day, it's only money. But that will not break the company, although it's going to be painful,'" he said.

Pfizer's experimental vaccine contains genetic material called messenger RNA, or mRNA,which scientists hope provokes the immune system to fight the virus.

Pfizer is one of three companies currently in late-stage testing for a vaccine. The other two are Moderna andAstraZeneca, which announced Saturday it would resume its trial after temporarily pausing it for safety reasons.

On Saturday, Pfizer submitted a proposal to the FDA to expand the late-stage trial to include up to 44,000 participants, a significant increase from its previous target of 30,000.

The developments come as infectious disease experts and scientists in recent weeks have said they have concerns that President Donald Trump is pressuring the FDA to approve a vaccine before it's been adequately tested. FDA Commissioner Stephen Hahn, insisting he wasn't being pressured by Trump to fast-track a vaccine,told The Financial Timeslast month the agency is prepared to bypass the full federal approval process in order to make a Covid-19 vaccine available as soon as possible.

On Sept. 8, nine drug companies, including Pfizer, released a letter pledging that they would prioritize safety and uphold " the integrity of the scientific process" in their efforts to develop coronavirus vaccines.

Even if a vaccine is approved to be distributed before the end of the year, it will likely be in short supply. The vaccine will likely require two doses at varying intervals, and states still face logisticalchallenges such as setting up distribution sites and acquiring enough needles, syringes and bottles needed for immunizations.

Earlier this month, the National Academies of Sciences, Engineering, and Medicine released a draft proposal for distributing a vaccine in the U.S. if and when one is approved for public use. The report was requested by the National Institutes of Health and the Centers for Disease Control and Prevention.

The vaccine would be distributed in four phases, with health-care workers, the elderly and people with underlying health conditions getting vaccinated first, according to the group. Essential workers, teachers and people in homeless shelters as well as people in prisons would be next on the list, followed by children and young adults.

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Pfizer coronavirus vaccine could be given to Americans before end of the year, CEO says - CNBC

Now, the bad news: In many of those states, testing has also decreased. And the overall number of daily new cases is still way too high as the US faces a trio of major challenges this fall.

On Sunday, 34,450 new cases were reported nationwide, according to data from Johns Hopkins University. That's better than the summer peak in late July, when the US had more than 60,000 new cases a day.

But nationwide, testing is down 10% this past week compared to the previous week, according to data from the Covid Tracking Project.

And of the confirmed cases we do know about, 34,450 is still an enormous number, health experts said Monday.

"We never really got the cases down. Remember, we're talking about 35,000 cases a day. Today, we're likely to hit over 40,000 cases a day," said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

"Back in April ... we had 22,000 cases a day and thought, 'My God, it can't get any worse.' And what's happening here is we're going to see this kind of up-and-down, up-and-down. But each time it goes up, it goes a little higher. Each time it comes down, it doesn't come down as far."

Nearly 550,000 children in the US have been diagnosed with Covid-19 since the pandemic began, according to the American Academy of Pediatrics and the Children's Hospital Association.

The groups found that children represent nearly 10% of all reported cases in the US.

Epidemiologists say the US must get the virus under control because the US will soon face several challenges simultaneously:

"You're going to have all these patients coming into hospitals and doctors office with symptoms that could be coronavirus, that could be the flu," Gounder said.

"And we're going to have to treat all of them like they have coronavirus. So that's a very dangerous and scary situation to be in."

Academic struggles: While millions of students grapple with online learning, many schools that brought students back to classrooms are suffering with outbreaks.

Athens-Clarke County, Georgia -- home to the University of Georgia -- has seen a "dramatic spike" in cases after maintaining lower case counts and death counts throughout the summer, Mayor Kelly Girtz said.

"Clearly, it's the return to campus of large numbers of students who are not here through the summertime," the mayor said.

Michigan State University students were asked to quarantine after the local health department reported 342 new cases among people affiliated with the university since August 24, East Lansing Mayor Aaron Stephens said.

While heath experts stress that a Covid-19 vaccine might not be publicly available until 2021, there are promising signs among several of the vaccines currently in Phase 3 trials.

Pfizer CEO Albert Bourla told CBS' "Face the Nation" that there was a "quite good chance" researchers will know by the end of October whether its experimental vaccine works.

"Then, of course, it is (the) regulator's job to issue (a) license or not," Bourla said.

"I think we should strive to have as more diverse population as possible," Bourla told CBS, stressing the importance of having a diverse group of volunteers given the heightened impact Covid-19 has had on communities of color.

"Right now we are not bad. Actually, we have a population that globally only 60% are Caucasians, 40%, approximately, minorities."

Moderna, which is also in Phase 3 testing for its vaccine, said its minority enrollment has also improved. About 59% of the participants are White, 22% are Hispanic, 11% are Black, 5% are Asian, and 3% are from other populations.

The world's largest vaccine manufacturer said if a Covid-19 vaccine requires two doses, it might be 2024 before everyone could get inoculated.

And that means production on a mammoth scale.

"I know the world wants to be optimistic on it... [but] I have not heard of anyone coming even close to that [level] right now," Poonawalla said. "It's going to take four to five years until everyone gets the vaccine on this planet."

Dr. William Schaffner, an infectious diseases professor at Vanderbilt University Medical Center, said he expects the timeline in the US to be faster.

"I suspect we'll have more vaccine for the United States before we have it for the entire world," Schaffner said.

Several vaccine makers in the United States have given their volunteers two doses during at least one phase of their clinical trials.

But "some vaccines under development right now require only one dose," Schaffner said. "So I think that timeline could be accelerated -- surely here at home, and even around the world."

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The US isn't even close to getting Covid-19 down to where it needs to be by fall, medical experts say - CNN

Trump: I'm not looking to be dishonest. I don't want people to panic. And we are going to be OK. We're going to be OK, and it is going away. And it's probably going to go away now a lot faster because of the vaccines.

It would go away without the vaccine, George, but it's going to go away a lot faster with it.

Trump: Sure, over a period of time. Sure, with time it goes away.

Stephanopoulos: And many deaths.

Trump: And you'll develop -- you'll develop herd -- like a herd mentality. It's going to be -- it's going to be herd-developed, and that's going to happen. That will all happen.

What that back-and-forth proves is that Trump's understanding of the virus, which has sickened more than 6 million Americans and killed almost 200,000, is still very, very rudimentary.

Let's get the one thing Trump got right in his answer out of the way: Yes, a vaccine would help reduce the number of people getting Covid-19. So when Trump says "it's probably going to go away now a lot faster because of the vaccines," he is, broadly speaking, correct -- if decidedly inarticulate.

Now to the rest of what Trump said.

First off, "herd mentality" is what drives Trump's supporters not to wear masks when gathering in large crowds (or ever). It's not what governs viruses.

It's not clear whether Trump was referring to herd immunity in the context of people getting Covid-19 or people getting the eventual Covid-19 vaccine. (Why wasn't Trump clear about that? Well, there's at least the possibility he doesn't know the difference.)

Which, well, wow.

If Trump was referring to the acquisition of herd immunity via vaccine, his repeated assertions that the virus will disappear quickly is also wrong.

Again, in order to achieve herd immunity, a very big chunk of the population needs to have the antibodies for the virus. That happens either by getting sick and recovering or by getting a vaccine that includes a small amount of antibodies that, ideally, create immunity to Covid-19.

Let's assume, for the sake of argument, that by January 1, 2021, a vaccine has been approved for widespread distribution that has proven effective in large numbers of people. In order to achieve Trump's idea of herd immunity, we need millions of Americans to get the vaccine.

In short: There really is no quick fix here. While a vaccine would undoubtedly increase -- rapidly -- the number of people with Covid-19 antibodies, it would not create herd immunity anytime soon.

It's not at all clear if Trump understands, well, any of this. He's just making promises about vaccines and riffing on "herd mentality" when the human cost of our ongoing fight against the coronavirus just keeps rising. What he doesn't seem to grasp is that none of this is going to just magically disappear -- no matter how many times he says it.

CORRECTION: This story has been updated to remove an unverified calculation about herd immunity and correct what is currently known.

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Donald Trump's answer on how the Covid-19 pandemic will end is, um, not comforting - CNN

Without masks and a vaccine, we could reach Herd Immunity from COVID-19, but deaths would skyrocket. We break down the science of it. USA TODAY

The United States plans to begin distributing coronavirus vaccine within 24 hours of one being approved, federal officials said Wednesday.

Its an audacious goal in an already franticly paced COVID-19 vaccine development and distribution program being overseen by the White House's aptly-named Operation Warp Speed.

The goal is that 24 hours after a licenseor an Emergency Use Authorization is issued "we have vaccine moving to administration sites," Lt. Gen. Paul A. Ostrowski, Operation Warp Speed deputy chief of supply, production and distribution, said on a media call Wednesday morning.

The initial rollout could begin as early as late this year or January.

The announcement came as the Centers for Disease Control and Prevention issued a 56-page playbook outlining details of how the vaccine will be distributed to medical providers nationally.

The vaccine initially willbe in short supply and will go to the most vulnerable, CDC director Dr. Robert Redfield testified to the Senate appropriations subcommittee on Labor, Health and Human Services, Education and Related Agencies later on Wednesday.

If youre asking me,When is it going to be available to the American public so we can begin to take advantage of vaccines to get back to our regular life? I think were probably looking at late second quarter, third quarter 2021, he said.

The vaccine will be available to any American who wants it regardless of ability to pay, assured officials. The vaccine itself, as well as the syringes and other equipment, will be distributed by and paid for by the U.S. government, the officials said.

An administration fee, basically a fee for giving the shot, can be charged by doctors offices, clinics and pharmacies but will either be paid for by private insurance,Medicaid, or federal funding.

There are still details to be worked out with Medicare fee-for-service providers. In the worst case, it will cost $3.50 per shot but were working on that, said Paul Mango, deputy chief of staff for policy in the office of the Secretary at the U.S. Department of Health and Human Services.

More: Scientists outraged by White House appointees' meddling with coronavirus information: 'Outright egregious'

More: The sprint to create a COVID-19 vaccine started in January. The finish line awaits.

More: 'Mind-bogglingly complex': Here's what we know about how COVID-19 vaccine will be distributed when it's approved

In a report to Congress and the accompanying "playbook" for states and localities, federal health agencies and the Department of Defense outlined complex plans for the vaccination campaign. It will begin slowly in January or potentially late in 2020 with the presumption that initially vaccine supplies will be limited. Within months, as more vaccine becomes available, the shots will be offered to every American who wants one.

Distribution will be through McKesson, a medical distribution company, working with the Pentagon for logistical and IT support. All shots will be given by civilian health workers, in health departments, clinics, hospitals, doctor's offices and pharmacies.

The campaign is "much larger in scope and complexity than seasonal influenza or other previous outbreak-related vaccination responses," according to the playbook.

Among the highlights:

Most of the candidate vaccines requiretwo doses. Some must be given21 days apart, others 28. The second dose must be from the same vaccine manufacturer. It's anticipated that eventuallyseveral vaccines from different manufacturers will be approved and available.

Health workers, other essential employees, and people in vulnerable groups will be allocated vaccine first. The National Academy of Medicine and the CDC's Advisory Committee on Immunization Practices are creating plans for who will be first in line.

Stateand local health departmentswill need to devise precise plans for receiving and locally distributing vaccines. All but one of the vaccines must be shipped frozen and one, from Pfizer, mustbe shipped at minus 94 degrees.

Each state has one month to submit its distribution plan.

Contributing: Associated Press

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Feds: COVID-19 vaccine will begin moving 24 hours after the first one is approved - USA TODAY

A New York state senator issued a warning to residents of suburban Nassau County about a letter that falsely claims the government is looking for "minorities to experiment on" with the coronavirus vaccines.

The letter was taped to the doors of dozens of homes on the North Shore of Long Island on Saturday, state Sen. Anna Kaplan said in a press release that included a redacted copy of the full letter.

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"Parents who will be sending their children to school this fall should be mindful of any and all documents or waivers they're asked to sign," the top portion of the letter reads. "In a rush to find a vaccine for the COVID-19 or Corona Virus, the government is looking for minorities to experiment on."

The bottom half of the letter falsely claims that by participating in certain programs for children, parents could be signing their child up "for something that will be extremely harmful to them."

Kaplan slammed the misinformation in the letter as dangerous.

"I'm absolutely disgusted that some coward would spend their time trying to scare parents with anonymous notes like this full of lies and conspiracy theories," she said in a statement. "There is absolutely no excuse for spreading misinformation and fear here in our community at a time when Nassau residents are doing their best just to get by during these incredibly challenging times.

Residents in Manhasset said the letter appears to be targeting low-income parents, according to NBC New York.

"It's unfortunate because theyre probably going through a lot right now so I think as a community as a unit we all need to come together," resident Lexie Peterka told the outlet.

Police are looking into the letters but, so far, have no leads, NBC New York reported. The Nassau County Police Department did not immediately return a request for comment Tuesday morning.

Minyvonne Burkeis a breaking news reporter for NBC News.

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Letter targets minorities on Long Island with coronavirus vaccine misinformation, state senator says - NBC News

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What George Washington University Doctors Are Learning About The Coronavirus Vaccine - DCist

The outbreakremainsout of control, Secretary-General AntnioGuterresdeclaredin hispress conferenceahead of theUNGeneral Assembly(UNGA)High Level Week, noting that soon onemillion liveswill be lost to the virus.

Recognizing that manypintheir hopes on a vaccine, hesaid,lets be clear: there is no panacea in a pandemic.

A vaccine alone cannot solve this crisis,certainly not in the near term,stressedtheworlds top diplomat.We need to massivelyexpand new and existing tools that can respond to new cases and provide vital treatment to suppress transmission and save lives, especially over the next 12 months.

Heemphasizedthat because the virus respects no borders,a vaccine mustbe seen asa global public good, affordable and available to all, but itrequiresa quantum leap in funding.

Moreover,people must be willing tobe vaccinated,buta proliferation of misinformation on vaccinesis fuelingvaccine-hesitancy,and igniting wild conspiracy theories, noted the UN chief.

He spoke of alarming reports thatlarge populationsinvariouscountriesare reluctant,oroutrightrefusing,to take anew coronavirusvaccine.

In the face of this lethal disease, we must do our utmost to halt deadly misinformation,affirmed the Secretary-General.

Mr. Guterres called for a global ceasefireback in March, recognizingthe coronavirusas the number one global security threat in our world today.

AndnextTuesday heflagged that would renewtheappeal at thebeginning of theGeneral Debate,forthe international communityto mobilize all efforts for the global ceasefire to become a reality by the end of the year.

The UN chief recapped that hopeful new steps toward peace have been taken,from Afghanistan to Sudan,anda slowdown infightinginSyria, Libya, Ukraine and elsewhere, had created an opportunityfor diplomacy.

In Yemen, we are pressing for a ceasefirehe said, and even thoughdistrust is deep across these and other crises,we must persevere.

We must seize every opening in the weeks ahead and make a new collective push for peace, upheldthe Secretary-General.

The UN chief then turned to otherglobal fragilities.

Even before the pandemic, the world was far off course in efforts to achieve the Sustainable Development Goals(SDGs)and losing the battle against climate change, he said.

Mr. Guterres recalledthat thenorthernhemispherewasjustcoming out of thehottest summer on recordand thatgreenhouse gas concentrationsin 2020hadreachednew record highs.

The world is burning, he told the journalists.

However,Mr. Guterresmaintained thatthe post-pandemic phaseofferedan opportunitytoget on track and tame the flames,but thatit must be greenaligned with the SDGs andthe Paris Climate Agreement.

Effective multilateralism,gender equalityand the voices of youthmust also be part of recoveryefforts.

Hesaidthat on Monday,Member Stateswould adopt a declaration marking theUNs75thanniversarycommitting to a reinvigorated multilateralism.

Global solidarityis required to transform the global economy, transition tozero carbon, ensureuniversal health coverage, movetowards a universal basic income,andshift tomore open and inclusivedecision-making, the UN chiefmaintained.

And itrejectsgo-it-alone nationalist approaches and divisive populist appeals,heasserted.

In this anniversary year,we face our own 1945 moment,the Secretary-Generalsaid, adding that it must be met with solidarity and unity like never beforeto overcome todays emergency, get the world moving,working and prospering againwhileupholdingthe vision of the Charter.

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UN chief: COVID-19 vaccine must be affordable and available to all - UN News

Bill Gates addresses a virtual Covid-19 conference hosted by the International Aids Society. July 11, 2020

International Aids Society Handout

Bill Gates doesn't believe any of the coronavirus vaccines in development are likely to seek U.S. approval before the end of October something that would be bad news for President Donald Trump, who has hinted at a viable vaccine to counter the pandemic before the Nov. 3 election.

"None of the vaccines are likely to seek approval in the U.S. before the end of October," the billionaire philanthropist told CNBC via video conference last week.

But Gates is more confident about a breakthrough by early next year and named one drugmaker as being the furthest ahead.

"I do think once you get into, say, December or January, the chances are that at least two or three will (seek approval) if the effectiveness is there," the Microsoft co-founder said.

"And so we have these phase three trials that are going on. The only vaccine that if everything went perfectly, might seek the emergency use license by the end of October, would be Pfizer."

The Gates Foundation, created by Gates and his wife, Melinda, announced in March a collaboration to develop a coronavirus vaccine with several life sciences companies including Pfizer. It also owns stock in Pfizer, as well as Johnson & Johnson, Merck and others and has given multimillion-dollar grants to Pfizer for the development of various vaccines in recent years.

On Monday, Pfizer CEO Albert Bourla told CNBC that its coronavirus vaccine, one of three vaccines from the West in late-stage testing, could be distributed to Americans before the end of the year if found to be safe and effective. The other drugmakers in late-stage testing that will potentially seek U.S. approval are Moderna and U.K.-based AstraZeneca.

"We do see good antibody levels both in the phase one and the phase two, so we're pretty hopeful," Gates said of those trials.

Beyond the U.S. and Europe, Russia and China have approved emergency use of their own vaccines, although these have been met with skepticism from some Western medical professionals.

If approved by the Food and Drug Administration, Pfizer is prepared to distribute "hundreds of thousands of doses," Bourla said, adding that the company should have late-stage trial data by the end of October. He said Pfizer had already invested $1.5 billion for the potential vaccine's development.

Over the weekend, Pfizer made a request to the FDA to expand the late-stage trial to include up to 44,000 participants, up from its earlier target of 30,000.

The American pharmaceutical giant has been working with German drug company BioNTech, and the U.S. government in July announced it would pay the firms $1.95 billion to produce and deliver 100 million doses of their vaccine if it proves safe and effective.

The deal was signed as part of Operation Warp Speed, the Trump administration's effort to accelerate development and production of vaccines and treatments to fight the coronavirus.

The Centers for Disease Control and Prevention have told U.S. states to be ready for vaccine distribution as early as Nov. 1, in line with Trump's reported push for a vaccine before the election. But the timing has caused concern among some experts who fear that safety protocols will be sidestepped for political reasons.

For Gates, a pledge from leading vaccine developers gives him confidence that that won't happen.

"The good news is that the leading vaccine companies today said that they won't apply even for the emergency use license until they have a proof of efficacy," he told CNBC. "We also have to go through all the safety steps so that people feel like they want to participate in taking this vaccine."

In a rare public letter published Sept. 8, the chief executives of nine major drugmakers pledged not to seek approval for their vaccines until their safety and effectiveness was proven in large clinical trials. The letter came amid reports that Trump was attempting to bypass the FDA's standard approvals process to get fast-track emergency use approval for an experimental vaccine, even if it hasn't yet received full regulatory approval.CNBC has reached out to the White House for comment.

"In the interest of public health, we pledge to always make the safety and well-being of vaccinated individuals our top priority," the letter said. It was signed by the CEOs of Pfizer, AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Moderna, Novavax and Sanofi.

CNBC's Berkeley Lovelace Jr. contributed to this report.

Correction: An earlier version had an incorrect date for the election.

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Bill Gates doesn't expect a virus vaccine before year-end but he says one drugmaker has the best chance - CNBC