COVID-19 Vaccine Update

A COVID-19 vaccine in early November? ‘Extremely unlikely, but not impossible’: Warp Speed head Slaoui – FiercePharma

With COVID-19 vaccine hype intensifying each day—including this week, with new comments from Pfizer’s CEO—the head of the U.S. government’s research program said it’s “extremely unlikely” a vaccine will be available in early November.

Moncef Slaoui, the Operation Warp Speed head, told NPR it remains “extremely unlikely, but not impossible” a vaccine will be ready by early November. Operation Warp Speed, a multibillion-dollar research program aimed at delivering 300 million doses of a COVID-19 vaccine by January, is performing “even better than I was hoping,” he said. With that, “there is a very, very low chance that the trials that are running as we speak could read before the end of October” and help score an emergency use authorization or approval.
Slaoui’s comments diverge from those of Pfizer CEO Albert Bourla, who this week said his company expects enough data in late October to make a decision about an FDA submission. In fact, the drug giant is already preparing its submission in case the vaccine shows early efficacy in the trial, Bourla said.

Featured Webinar

Improving Patient Outcomes & Clinical Trials With Visual Analytics

Drug Development has always been about data. Research insight that comes from data often gets muddied by its vastness and inaccessibility. In this session we discuss Takeda Pharmaceutical’s Platypus, a comprehensive set of Tableau visualizations of clinical trial data. Register for this webinar to learn more.

Meanwhile, the Centers for Disease Control and Prevention is working with states and localities to prepare vaccine distribution sites for Nov. 1, according to press reports from earlier this week. Pfizer, Moderna and AstraZeneca vaccines are already in late-stage testing, but it’s unclear when the studies will produce sufficient safety and efficacy data. It’s also unclear how long it would take to get data published and how long an FDA review would take.
That Nov. 1 target date has raised questions of whether the White House is applying political pressure to speed the vaccine approval process up. President Donald Trump and allies have said a vaccine will be ready by the end of the year or sooner, apparently seeking a political boost with the presidential election two months away. 
RELATED: CDC sets its sights on November COVID-19 vaccine deliveries: report 
On that topic, Slaoui said that for the Warp Speed crew, “there is absolutely nothing to do with politics.” 
“Many of us may or may not be supportive of this administration. It’s irrelevant, frankly,” he noted. In a separate interview, Slaoui told Science he would “immediately resign if there is undue interference in the vaccine process.” 
The former GlaxoSmithKline vaccine exec was named head of Operation Warp Speed back in May. At the time, he said he was “confident” the U.S. would have a vaccine by the end of the year. 

Moderna slows coronavirus vaccine trial enrollment to ensure minority representation, CEO says – CNBC

Moderna, one of the developers in the lead for a vaccine to prevent Covid-19, is slowing enrollment slightly in its large clinical trial to ensure it has sufficient representation of minorities most at risk for the disease, its chief executive said.
The trial is designed to enroll 30,000 people in the U.S. to prove the vaccine’s safety and efficacy. As of Aug. 28, it had enrolled 17,458, 24% of whom are from communities of color. The company provides updates on enrollment numbers every Friday afternoon.

Moderna shares, which have a market value of $23.5 billion, were down more than 8% after the news, and had recovered somewhat by early afternoon. The stock has risen 211% since the start of the year. 
Enrolling the elderly, communities of color and people with underlying health conditions is a priority for the coronavirus vaccine trials, given they’re at greater risk from the disease. Public health experts note inclusion of diverse groups is important for ensuring the vaccines work in every population, and for building trust among all communities to take the vaccine if and when it becomes available.
“The Black community has been disproportionately impacted by the pandemic, and that’s not biological but rather due to socioeconomic inequities resulting from racism,” said Angela Rasmussen, a virologist at Columbia’s Mailman School of Public Health. “It is particularly important to make sure that Black and Latinx participants are represented equitably in the trials and the vaccine shows protective efficacy in different populations of people.”
Moderna’s data show that two-thirds of those enrolled in the study are White, 20% are Hispanic or Latino and 7% are Black.
“We believe we could have one of the best vaccines,” Moderna CEO Stephane Bancel told CNBC. “We want to ensure we have data for all the people who could benefit and be protected.”

Bancel said the company’s goal is for enrollment to line up with U.S. Census Bureau numbers. In 2019, the Census Bureau estimated 18.5% of people in the U.S. are Hispanic or Latino, and 13.4% are Black or African-American alone.
Moderna started its trial on July 27, the same day as pharmaceutical giant Pfizer. Pfizer’s CEO said Thursday the company had enrolled 23,000 people of its planned 30,000, ahead of schedule, and that data showing whether the vaccine works could be available as soon as the end of October.
As of Monday, 25% of U.S. participants in Pfizer’s trial were Asian, Black, Hispanic/LatinX or Native American, the company said. Eight percent were Black.
And though the enrollment numbers for minorities lag where experts hoped they’d be, they’re still ahead of a national registry for those expressing interest in Covid-19 vaccine trials. NBC News reported this week the registry for the Coronavirus Prevention Network, a group formed by the National Institute of Allergy and Infectious Diseases to conduct vaccine and antibody therapy trials, included only 40,000 people from minority groups of 360,000 people total who expressed interest in trials — about 11%.
White House advisors cast doubt on Pfizer’s projection that data could be available as soon as the end of next month. NIAID Director Dr. Anthony Fauci told CNN it’s “unlikely but not impossible,” and that most experts are anticipating November or December for trial data. Moncef Slaoui, lead advisor to the government’s Operation Warp Speed, told NPR there’s a “very very low chance that the trials… could read [out] before the end of October.”
Pfizer is part of Operation Warp Speed, but didn’t accept government funding — or participation — for the development and trials of its vaccine, which is partnered with German developer BioNTech. It gets paid $1.95 billion for 100 million doses only if the vaccine is successful.
Moderna partnered with Fauci’s NIAID early on in the pandemic to develop its vaccine candidate, and has received almost $1 billion in government funding for development, in addition to a purchase order for $1.53 billion for 100 million doses.
Bancel didn’t provide a new projection for when the study might be fully enrolled or show data. When the trial began, he had told CNBC in an interview that data could be available in October in “a really optimistic scenario; maybe November.”
Friday he noted “a small delay to have a better quality trial is the right decision in the long run,” saying the company has told several clinical trial sites “they need to do better” in reaching minorities.
“I would rather we have higher diverse participants and take one extra week,” Bancel said. Diversity “matters more to us than speed.”
Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said he was glad to hear Moderna was ensuring diversity in its trial even if it caused a slight delay.
“It is important for when you roll this vaccine out, because people are skittish, groups like the African-American/Black community need to know they’ve been represented in the trials, and the vaccine has been found to be safe and effective for them,” Offit said in an interview.
The vaccine needs to be proven to work in “those greater than 65, minority groups, those with certain medical conditions like obesity, because those are the people who are going to get it first,” he said.

Prominent US doctors break down which coronavirus tests will curb transmission rates

Coronavirus tests: which one should you take?
New coronavirus tests are being developed every day. The Trump administration just ordered 150 million rapid antigen tests from Abbott Laboratories, but how do they stack up against other tests like the Polymerase chain reaction (PCR) test? Top infectious disease doctors from Harvard and Johns Hopkins break down the differences between the two tests to determine which diagnostic tool might be better at curbing transmission rates.

Rapid antigen tests could play a pivotal role in curbing the spread of the coronavirus, according to some of the country’s top medical professionals.

Antigen tests are the type of tests the White House just ordered from Abbott Laboratories in a  $750 million deal that will reportedly buy 150 million of its new rapid coronavirus tests: the BinaxNOW COVID-19 Ag Card.
The Trump administration announced it will begin distributing these new rapid coronavirus tests to governors in mid-September.
“The recent one that just came out by Abbott shows that they have around a 97% sensitivity to detect people in the first week of infection of symptoms. And that, we know, is when people are most likely to transmit to other people,” Dr. Michael Mina, an epidemiologist at Harvard T.H. Chan School of Public Health told Fox News.

President Trump’s new coronavirus adviser, Dr. Scott Atlas, said this massive number of tests will be deployed in a variety of ways, including to in-home care and senior centers.

“We’re going to send a lot to the states because the governors are in charge of their states and we’re there to support them. And however they decide to use them and allocate them in their states, they will have the flexibility, of course, to do that. This is a federalist system. We don’t dictate to every state what they’re going to do,” Atlas told Fox News.
PHASE III TRIALS OF CORONAVIRUS VACCINE TO TAKE PLACE AT 5 US MILITARY SITES, PENTAGON CONFIRMS

An antigen test looks for proteins of the virus or the actual shapes of the molecules that make up the virus. The test is done with a nasal or throat swab at a hospital or doctor’s office, but the hope is that these tests will soon be available for home testing in the near future. According to reports, the Abbott test is for patients who have had COVID-19 symptoms for seven days or less and must be prescribed by a physician and performed by a health care worker.

The biggest benefit, some say, is the fact that the test costs $5 and can deliver results within 15 minutes.

The Food and Drug Administration on Wednesday, Aug. 26, 2020, authorized BinaxNOW, the first rapid coronavirus test that doesn’t need any special computer equipment to get results. (Abbott Laboratories via AP)

Also, the new Abbott test doesn’t require a machine, which has been called a real plus, according to Dr. Gigi Gronvall, a senior scholar and associate professor at the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health. “It does make it easier to put it in more places. So you could have a school nurse, for example, administer this test versus having to get all the equipment that will allow you to read it, which is found more in laboratory settings,” she told Fox News.

Antigen vs. PCR tests
The diagnostic tool that is considered the “gold standard” for COVID-19 testing is the polymerase chain reaction (PCR) test.
PCR tests look for the genetic material of the virus — or the RNA, which is like human DNA for the virus. Mina said you can compare finding virus RNA with how detectives find and use DNA at crime scenes.

“RNA could be very, very powerful to let you know if you have any of the virus in you or even if you’ve had it in you in the past few weeks,” Mina explained. “But that means it can stay positive for quite a long time in the same way that DNA can stay positive if you find a person’s hair on the floor, you can find that that person was in the location.”
According to the Centers for Disease Control and Prevention, the sensitivity of rapid antigen tests ‒ or the ability of the test to correctly identify people with the infection ‒ is generally lower than PCR. The agency’s website states that the first two antigen tests that have received Emergency Use Authorization (EUA) from the Food and Drug Administration demonstrated a sensitivity of 84% and 97% compared to PCR.

ARE FLU SHOTS SAFE AMID THE CORONAVIRUS PANDEMIC?

Experts also say that, because it takes such a high volume of virus to generate a positive result in antigen tests, some patients who have been symptomatic for more than five days may drop below the limit of detection of the test, possibly resulting in a false negative result, while a PCR test, the more sensitive test, would be able to catch those small amounts of virus and return a positive result.

To minimize the amount of false negative cases, Dr. Gronvall said ideally people should follow-up a negative test with a PCR test to get clarity on whether they are in fact infectious
“At the end of the day, though, it’s better to have more testing and have more people getting tested, because even if it doesn’t give the right result all the time, if more people are doing it, the models show that it will help to reduce the transmission,” Gronvall said.

PCR tests are considered the “gold standard” of SARS-CoV-2 testing

PCR tests, also known as molecular tests, are performed at a hospital or medical office. One of the biggest differences between PCR and antigen tests is the speed of the test. The sample taken during a PCR test is typically sent to a lab where results are turned around between 24-hours up to a week, depending on lab capacity.
“Speed is so important for these tests because if you’re going do anything with the information, you need to have it quickly. Having a test that’s super sensitive and then it takes you days to learn what the answer is, is not going to help anyone because you’re going around and potentially interacting with people and potentially exposing people during that time when you are waiting for the results of your test,” Gronvall said.

Although antigen tests may not be as sensitive as PCR tests, frequent testing will be key to staying ahead of the curve, Mina said.

“The ability to pick up 10 molecules doesn’t really tell you much about somebody’s infectivity status. But if you have a test that can pick up one hundred thousand or more, then that will get you very far along the road to being able to pick up all the people who are transmitting,” Mina said. “I would like to see them [antigen tests] be used by everyone before they leave their house in the morning, especially people where outbreaks are still pretty large, places in Georgia, Florida, as these can be used to stop transmission chains by giving people knowledge of their transmissibility status every day.”

While COVID-19 continues to infect thousands of Americans as fall and winter months approach, the government has stepped up its support for new testing methods.
CLICK HERE TO GET THE FOX NEWS APP

The National Institutes of Health recently announced it is providing nine more companies with $129.3 million as part of its Rapid Acceleration of Diagnostics (RADx) initiative.
“There is no drawback in testing being done here. We are going to increase testing. We’re going to do it even smarter than what was done in the past with leveraging this incredible capacity to do tests. And we’re going to result in saving more lives,” Atlas said.

Russia’s Covid-19 vaccine generated an immune response, study says – CNN International

Russia drew criticism when it announced the world’s first approved coronavirus vaccine for public use in August — even before crucial Phase 3 trials had been completed.
In the Phase 1 and 2 studies of the vaccine, which is named Sputnik V, all 76 study participants developed antibodies to the virus that causes Covid-19, according to Friday’s report in The Lancet.

The levels of neutralizing antibody response were similar to the immune response that people had after naturally recovering from Covid-19, according to the study.

The researchers also looked at responses from T cells, another component of the immune system.

“[Outcomes from] the trial also suggest the vaccines also produce a T cell response within 28 days,” the researchers wrote.

Larger trials needed

Scientists not involved in the study said that, while the results are a positive sign, only larger, Phase 3 trials can confirm whether the vaccine actually prevents illness with Covid-19.
“The data on the Russian vaccine studies reported in The Lancet are encouraging,” said Brendan Wren, professor of microbial pathogenesis, London School of Hygiene and Tropical Medicine.
In the study, half of the participants developed fevers and 42% developed headaches. In addition, about 28% experienced weakness and 24% had joint pain.
The article did not say how long these side effects lasted but said “most adverse events were mild.”
The vaccine was registered in Russia in August, before it had gone through large-scale trials. The researchers at the Gamaleya National Research Centre for Epidemiology and Microbiology in Russia received approval on August 26 to do a Phase 3 trial, which is expected to have 40,000 volunteers, according to a press release from The Lancet.

The researchers are already distributing the vaccine to high-risk groups, according to Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), which is financing Russian vaccine research.
Gamaleya is using adenoviruses in their Covid-19 vaccines; this is the same approach used in the vaccine developed by the University of Oxford and AstraZeneca. The adenovirus delivers genetic material for the spike protein that sits atop the virus that causes Covid-19, and that genetic material is designed to generate an immune response to the virus.
Adenoviruses can cause a variety of symptoms, including the common cold. The researchers manipulate the virus so it will not replicate and cause illness.
The Gamaleya vaccine is given in two doses, and each dose uses a different adenovirus vector.
“Using two different viruses gives a theoretical advantage,” said Dr. Paul Offit, a vaccinologist at the University of Pennsylvania.
Naor Bar-Zeev, deputy director of the International Vaccine Access Center at Johns Hopkins University, said in a linked comment that the studies are “encouraging but small,” according to The Lancet. Bar-Zeev was not involved in the Russian study, but peer reviewed it.
Dmitriev, CEO of the RDIF, said that the trial results confirm the “high safety and efficacy” of the vaccine, adding in a statement Friday that the results are “a powerful response to skeptics who unreasonably criticized the Russian vaccine.”

Mass trials begin next week

Russia has previously said it plans to begin mass vaccination of citizens in October, and the country’s health ministry has said the country’s frontline medical staff and teachers will be the first vaccinated.
Post-registration trials of the vaccine will begin in Moscow next week, the city’s mayor, Sergey Sobyanin, said Friday.
More than 5,000 people have already signed up to participate in the trials, according to Sobyanin, who spoke during a video conference with Russian President Vladimir Putin.

Sobyanin also announced that he had been vaccinated with the first of the vaccine’s two shots.
The mayor said polls suggest around half of Russian citizens are skeptical about the vaccine.
“According to the polls, around half doubt whether they need to get vaccinated for coronavirus, whether it is developed enough or not. Two months ago, there were almost 90% skeptics,” said Sobyanin.

Without completed Phase 3 trials, Russia has not proven to the world Sputnik V works, though Dmitriev has previously said several countries in Latin America, the Middle East and Asia have expressed interest in procuring the vaccine.
Russia isn’t the only country fast tracking its vaccine — China approved an experimental coronavirus vaccine in June for members of its military, and in August, it emerged the country had been using the vaccine on those in “high risk” professions — such as frontline medical professionals and border inspectors — since July.

CNN’s Zamira Rahim and Amy Woodyatt contributed to this report.

Widespread Covid Vaccination Not Expected Until Middle Of Next Year: WHO – NDTV

Need to see how truly protective the vaccine is and how safe it is, the WHO says. (Representational)

Geneva:
The World Health Organization does not expect widespread vaccinations against COVID-19 until the middle of next year, a spokeswoman said on Friday, stressing the importance of rigorous checks on their effectiveness and safety.
None of the candidate vaccines in advanced clinical trials so far has demonstrated a “clear signal” of efficacy at the level of at least 50% sought by the WHO, spokeswoman Margaret Harris said.
Russia granted regulatory approval to a COVID-19 vaccine in August after less than two months of human testing, prompting some Western experts to question its safety and efficacy.
US public health officials and Pfizer Inc said on Thursday a vaccine could be ready for distribution as soon as late October. That would be just ahead of the US election on Nov. 3 in which the pandemic is likely to be a major factor among voters deciding whether President Donald Trump wins a second term.
“We are really not expecting to see widespread vaccination until the middle of next year,” Harris told a UN briefing in Geneva.
“This phase 3 must take longer because we need to see how truly protective the vaccine is and we also need to see how safe it is,” she added. This referred to the phase in vaccine research where large clinical trials among people are conducted. Harris did not refer to any specific vaccine candidate.

All data from trials must be shared and compared, Harris said. “A lot of people have been vaccinated and what we don’t know is whether the vaccine works…at this stage we do not have the clear signal of whether or not it has the level of worthwhile efficacy and safety…,” she added.
The WHO and GAVI vaccine alliance are leading a global vaccine allocation plan known as COVAX that aims to help buy and distribute shots fairly. The focus is on first vaccinating the most high-risk people in every country such as healthcare workers.
COVAX aims to procure and deliver 2 billion doses of approved vaccines by the end of 2021, but some countries that have secured their own supplies through bilateral deals, including the United States, have said they will not join.

As progress continues on coronavirus vaccine, experts debate who should be 1st to receive it – ABC News

Deciding who should get the vaccine first is not an easy question.

By

Dr. Dave Harrison

September 4, 2020, 9:01 AM
• 6 min read

Share to FacebookShare to TwitterEmail this article

With potential authorization for a COVID-19 vaccine by the Food and Drug Administration within striking distance, scientists and public health experts are deliberating which Americans should receive the initial, limited supply. A panel of experts gathered this week has recommended prioritizing front-line health care workers, followed by adults with serious underlying medical conditions and seniors living in nursing homes or crowded living environments.
The recommendations, made by a committee of scientists from the National Academies of Science, Engineering and Medicine, were part of a first draft of recommendations for COVID-19 vaccine prioritization. Once finalized, those recommendations will be handed over to the Centers for Disease Control and Prevention, tasked with rolling out the vaccine.

The committee included representation from experts in epidemiology, vaccine research, public health, ethics and law.
“We looked at issues of ensuring maximal benefit, promoting common good, saving the greatest number of lives possible,” Dr. Helene Gayle, committee co-chair, said during her opening remarks for the Equitable Allocation of COVID-19 Vaccine Public Listening Session, which took place virtually on Sept. 2.

The plan, as introduced by the document, details a four-phase approach, with Phase 1 serving workers in health care facilities and at-risk seniors. Phase 2 includes other medically high-risk individuals and other essential workers, such as teachers and school staff. Phases 3 and 4 will ultimately reach healthy adults and children who are yet to be vaccinated.
During a public hearing, some doctors and public health experts expressed concerns over the committee’s decision to not explicitly prioritize race and ethnicity. The pandemic has disproportionately impacted Black and Hispanic people and other people of color.
“Any strategy to decrease the mortality rates due to coronavirus must account for the greater percentage of Black and brown deaths per capita,” said Dr. Randall Morgan, executive director of the Cobb/National Medical Association Health Institute, which promotes the interests of over 50,000 African American physicians. “The causes are multifactorial, however, the lack of availability or acceptance of the vaccine will simply compound this situation.”

A woman walks inside the Research Centers of America in Hollywood, Fla., on Aug. 13, 2020, which is conducting COVID-19 vaccine trials.

A woman walks inside the Research Centers of America in Hollywood, Fla., on Aug. 13, 2020, which is conducting COVID-19 vaccine trials.

The committee, however, offered reassurances that although race is not a criteria for vaccination, the plan does take race into account. Early vaccine efforts will target communities hit hardest by COVID-19 based on the CDC’s “Vulnerability Index,” a calculated measure of who is most vulnerable.

“We took the approach that this virus doesn’t understand skin color at all, but it understands vulnerabilities: heart failure, kidney failure, a body mass index greater than 40,” said Dr. William Foege, co-chair of the committee. “Some of the social vulnerabilities have to do with crowding, with people who have to go to work and don’t have an option, with multigenerational occupancy. So we looked at those things and we put those first in line rather than saying skin color is the way we’ll make this decision.”
The plan set forth by the committee will continue to be adapted over the coming weeks and months, and a version of it may ultimately serve as the primary framework for guiding vaccine distribution in the United States.

But this isn’t the only committee weighing in on the highly debated topic of who should get a vaccine first. While most experts agree that vulnerable populations should receive vaccine priority, not everyone agrees which members of society are the most vulnerable.
An editorial released Thursday in the journal Science focused on another metric: years of life saved. This group, a consortium of global experts, criticized population-based vaccine allocation.
Instead, they used a metric called “standard expected years of life lost” — effectively a way to measure the collective benefit of vaccines in terms of preventing premature death. With this model, premature deaths are most common in countries with fewer resources, less capable of hospitalizing and treating patients who would otherwise survive.

In this file photo taken on Aug. 13, 2020, Sandra Rodriguez, 63, receives a COVID-19 vaccination test from Yaquelin De La Cruz at the Research Centers of America in Hollywood, Fla.

In this file photo taken on Aug. 13, 2020, Sandra Rodriguez, 63, receives a COVID-19 vaccination test from Yaquelin De La Cruz at the Research Centers of America in Hollywood, Fla.

“Equally populous countries can face markedly different levels of premature death and economic devastation from COVID-19,” the authors wrote, arguing that their model would create a more equitable vaccination strategy for lower-income countries.
Meanwhile, the World Health Organization suggests that countries should receive vaccine doses proportional to population, regardless of that country’s income.
Similar to the National Academies of Science, Engineering and Medicine’s approach, it would start with health care workers, older adults and high-risk individuals, with the ultimate goal of providing vaccination to 20% of the population of participating countries by the end of 2021.
Dave Harrison, M.D., is a pediatric cardiology fellow in Boston and a contributor to the ABC News Medical Unit.

Azar says it’s ‘irresponsible’ to suggest politics at play in coronavirus vaccine race

Health and Human Services (HHS) Secretary Alex Azar said it’s “irresponsible” to suggest politics are at play in the race to approve a coronavirus vaccine.

During an appearance Thursday on CBS, anchor Tony Dokoupil said that “people are worried politics is leading” after the Centers for Disease Control (CDC) issued a letter to governors to be prepared for a vaccine by Nov. 1. He asked if the date had any relation to the election set for two days later.
“It’s very irresponsible how people are trying to politicize notions of delivering a vaccine,” Azar said. “We already have a significant challenge in this country with vaccine hesitancy.”
“Any vaccine that comes out is going to meet FDA’s gold standards for authorization or licensure,” he added. “The president’s made that clear. I’ve made that clear. The FDA commissioner has made that clear.”

AZAR REJECTS CLAIMS TRUMP PRESSURED FDA TO APPROVE CONVALESCENT PLASMA CORONAVIRUS TREATMENT 

Azar noted that three vaccine candidates by drugmakers AstraZeneca, Moderna and Pfizer/BioNTec are currently in late-stage Phase3 clinical trials.
Pressed on whether the target date was merely “a coincidence,” Azar asserted it had nothing to do with elections.

“You’d have to ask Dr. Messonnier, because that came out of the career people at CDC working to do the planning here,” he said. “It has nothing to do with elections.” Dr. Nancy Messonnier is  the agency’s director of the National Center for Immunization and Respiratory Diseases.

Some have expressed concerns that the administration might pressure the FDA to fast-track approving a vaccine before the 2020 election. FDA Commissioner Stephen Hahn and federal health officials have sought to quell such rumors and assure the public that the eventual vaccine will be safe and effective.

WHITE HOUSE RECOMMENDS IOWA CLOSE BARS 

At a news briefing Thursday, White House press secretary Kayleigh McEnany insisted that “no one is pressuring the FDA to do anything.”
“This president wants to break through regulatory barriers to get a vaccine to the American people as quickly as possible because lives are at stake,” she said. “But he will not in any way sacrifice safety and making sure that this is 100 percent airtight for the American people [who] receive it.”
Dr. Anthony Fauci also told CNN that Americans should not worry that politics are speeding up the vaccine timeline. “I think that we can have some confidence and have faith in what the FDA is saying,” Fauci said.

CLICK HERE TO GET THE FOX NEWS APP
In an NBC appearance, Fauci predicted a safe and effective vaccine before the end of the year.

Who will get the coronavirus vaccine first? We need to plan now – The Conversation UK

In the race to develop a COVID-19 vaccine, a lot of attention has been paid to the types of vaccines being developed and their progress through the various stages of clinical trial. A lot less attention has been paid to what happens after a vaccine is approved by the regulators.
As recognised by a US scientific committee, governments need to start planning how they will distribute a vaccine efficiently and fairly, because, when a vaccine is approved, most countries won’t have enough doses to vaccinate everyone.
Governments need to make decisions now so that vaccine allocation can begin as soon as one becomes available. Without a clear plan, valuable time will be lost and governments may be forced into quick decisions that fail to realise the full potential of a vaccine.
So what are these decisions governments must make? First, should they allow the vaccine to be bought privately or only through public channels, such as a country’s national health service? In most countries, people can gain preferential access to most medicines by buying them privately. However, the pandemic is arguably akin to a war situation where vital goods in limited supply should be rationed.
Next, what criteria should be used to decide how to allocate the initially limited doses of the vaccine? Prioritising who should receive the vaccine will involve balancing different, sometimes competing, considerations. Key considerations must include: reducing the most severe health effects of COVID-19, reducing the rate of transmission, and allowing the economy to return to normal.
The allocation must also be fair. This is especially important considering that COVID-19 affects disadvantaged groups particularly badly. So vaccination programmes could also be assessed according to how much they are likely to increase or decrease existing inequalities.
Governments should also plan what to do if there are not enough doses to cover all people assigned the same priority. Arguably the fairest way to do this would be to hold a lottery.
Developing a framework
Vaccinating a particular group will have a variety of effects. It will help to prevent severe COVID-19 among those vaccinated. It will reduce the spread of the virus because those vaccinated will be less likely to pass the virus to others. And it may enable people to return to work safely, helping the economy get back to normal.
Governments should assess the likely size of these effects, based on the best evidence, when considering how high a priority any particular group should get. Fortunately, there is more and more evidence available to help. With the help of scientists, governments now need to bring all this evidence together and create a framework – as we recommend in our recent paper – for understanding the likely benefits of adopting different vaccine-allocation strategies.
The framework will need to include an evaluation of the relative benefits of vaccinating different groups. For example, predicting the overall benefits of vaccinating people who work in the retail and service sector may entail taking into account health benefits to staff, societal health benefits via lower transmission to shoppers, and benefits to the economy such as allowing more shops to open.
Similarly, those caring for elderly relatives may gain only a small individual health benefit, but their vaccination may prevent COVID-19 in the people they look after, and allow them to return to their office without worrying so much about passing the virus to their elderly loved ones.
Flowchart of decisions governments must make about allocating a vaccine. Author provided, CC BY-NC
Beyond combining evidence from research to assess the probable benefits of vaccination strategies, governments and researchers could seek public opinion on key aspects of the vaccine distribution. Scientists have long advocated for public participation in medical research.
Views from the public could inform the extent to which a vaccination strategy prioritises health benefits versus wider benefits, such as enabling a safe return to schools and protecting jobs and the economy. Also, public opinion could inform whether private sale of a vaccine should be banned and whether it could be distributed via lotteries among those with equal need.
As well as developing clear criteria on which to base allocation, many practical issues about the vaccine roll-out will need to be resolved, such as the cost and efficiency of administering it at the workplace as opposed to in hospitals and clinics.
While governments need to make decisions at a national level, there also needs to be a coordinated international effort. To date, high-income countries have already ordered more than two billion vaccine doses. International efforts to acquire a similar number of doses for low and middle-income countries are struggling to gain traction. The infectious nature of COVID-19 means that it is in the interest of all countries to ensure the pandemic is contained globally.
The race to defeat COVID-19 will be won in stages. After developing a vaccine, the next challenge will involve its allocation. We should prepare for this stage now. As most athletes will attest, preparation is the key to a strong performance.

Third virus vaccine reaches major hurdle: Final US testing

A handful of the dozens of experimental COVID-19 vaccines in human testing have reached the last and biggest hurdle: looking for the needed proof that they work as a U.S. advisory panel suggested Tuesday a way to ration the first limited doses once a vaccine wins approval.

AstraZeneca announced Monday its vaccine candidate has entered the final testing stage in the U.S. The Cambridge, England-based company said the study will involve up to 30,000 adults from various racial, ethnic and geographic groups.
AMID CORONAVIRUS, IS IT SAFE TO SEND CHILDREN BACK TO SCHOOL? EXPERTS, PARENTS WEIGH IN
Two other vaccine candidates began final testing in tens of thousands of people in the U.S. this summer. One was created by the National Institutes of Health and manufactured by Moderna Inc., and the other developed by Pfizer Inc. and Germany’s BioNTech.

“To have just one vaccine enter the final stage of trials eight months after discovering a virus would be a remarkable achievement; to have three at that point with more on the way is extraordinary,” Health and Human Services Secretary Alex Azar said in a statement.

FILE – In this Aug. 14, 2020, file photo, laboratory technicians work at the mAbxience biopharmaceutical company on an experimental coronavirus vaccine developed by Oxford University and the laboratory AstraZeneca in Garin, Argentina. AstraZeneca announced Monday, Aug. 31, its vaccine candidate has entered the final testing stage in the U.S. (AP)

NIH Director Francis Collins tweeted that his agency “is supporting several vaccine trials since more than one may be needed. We have all hands on deck.”
AstraZeneca said development of the vaccine, known as AZD1222, is moving ahead globally with late-stage trials in the U.K., Brazil and South Africa. Further trials are planned in Japan and Russia. The potential vaccine was invented by the University of Oxford and an associated company, Vaccitech.

Meanwhile, a U.S. advisory panel released a draft plan Tuesday for how to ration the first doses of vaccine. The National Academies of Sciences, Engineering and Medicine proposed giving the first vaccine doses — initial supplies are expected to be limited to up to 15 million people — to high-risk health care workers and first responders.

Next, older residents of nursing homes and other crowded facilities and people of all ages with health conditions that put them at significant danger would be given priority. In following waves of vaccination, teachers, other school staff, workers in essential industries, and people living in homeless shelters, group homes, prisons and other facilities would get the shots.

Healthy children, young adults and everyone else would not get the first vaccinations, but would be able to get them once supplies increase.

The panel of experts described “a moral imperative” to lessen the heavy disease burden of COVID-19 on Blacks, Hispanics, Native Americans and Alaska Natives, and suggested state and local authorities could target vulnerable neighborhoods using data from the Centers for Disease Control and Prevention.
The National Academies will solicit public comments on the plan through Friday.
There’s a good reason so many COVID-19 vaccines are in development.

“The first vaccines that come out are probably not going to be the best vaccines,” Dr. Nicole Lurie, who helped lead pandemic planning under the Obama administration, said at a University of Minnesota vaccine symposium.
There’s no guarantee that any of the leading candidates will pan out — and the bar is higher than for COVID-19 treatments, because these vaccines will be given to healthy people. Final testing, experts stress, must be in large numbers of people to know if they’re safe enough for mass vaccinations.

They’re made in a wide variety of ways, each with pros and cons. One problem: Most of the leading candidates are being tested with two doses, which lengthens the time required to get an answer — and, if one works, to fully vaccinate people.

Another: They’re all shots. Vaccine experts are closely watching development of some nasal-spray alternatives that just might begin the first step of human testing later this year — late to the race, but possibly advantageous against a virus that sneaks into the airways.

For now, here’s a scorecard of vaccines that already have begun or are getting close to final-stage tests:
GENETIC CODE VACCINES

The Moderna and Pfizer candidates began Phase 3 testing in late July.
Neither uses the actual coronavirus. Instead, they’re made with the genetic code for the aptly named “spike” protein that coats the surface of the coronavirus. Inject the vaccine containing that code, called mRNA, and the body’s cells will make some harmless spike protein — just enough for the immune system to respond, priming it to react if it later encounters the real virus.

These mRNA vaccines are easier and faster to make than traditional vaccines, but it’s a new and unproven technology.

TROJAN HORSE VACCINES
Britain’s Oxford University and AstraZeneca are making what scientists call a “viral vector” vaccine but a good analogy is the Trojan horse. The shots are made with a harmless virus — a cold virus that normally infects chimpanzees — that carries the spike protein’s genetic material into the body. Once again, the body produces some spike protein and primes the immune system, but it, too, is a fairly new technology.
Two possible competitors are made with different human cold viruses.

Shots made by Johnson & Johnson began initial human studies in late July. The company plans to begin Phase 3 testing in September in as many as 60,000 people in the U.S. and elsewhere.
China’s government authorized emergency use of CanSino Biologics’ adenovirus shots in the military ahead of any final testing.
‘KILLED’ VACCINES

Making vaccines by growing a disease-causing virus and then killing it is a tried-and-true approach — it’s the way Jonas Salk’s famed polio shots were made. China has three so-called “inactivated” vaccine candidates against COVID-19 made this way.

Sinovac has final studies of its candidate underway in Brazil and Indonesia. Competitor SinoPharm has announced plans for final testing in some other countries.
Safely brewing and then killing the virus takes longer than newer technologies. But inactivated vaccines give the body a sneak peek at the germ itself rather than just that single spike protein.

WHY TEENS ATTEMPT VIRAL TIKTOK, SOCIAL MEDIA CHALLENGES DESPIRE APPARENT DANGERS 
PROTEIN VACCINES

Novavax makes “protein subunit” vaccines, growing harmless copies of the coronavirus spike protein in the laboratory and packaging them into virus-sized nanoparticles.

There are protein-based vaccines against other diseases, so it’s not as novel a technology as some of its competitors. But it only recently finished its first-step study; the U.S. government’s Operation Warp Speed aims for advanced testing later in the fall.
___

AP journalist Danica Kirka in London contributed to this report.

America reportedly suffering monkey shortage for coronavirus vaccine search

This is bananas.

US researchers working frantically to test potential COVID-19 vaccines are facing a critical shortage of one essential resource — monkeys.
“Nationally, there is basically a big shortage,” Koen Van Rompay, an infectious-disease scientist at the California National Primate Research Center, told The Atlantic.
DIETS HIGHER IN PROTEIN, PARTICULARLY PLANT PROTEIN, LINKED TO LOWER RATES OF EARLY DEATH: STUDY

Primate research in the country was already pricey and controversial — but the coronavirus pandemic has been particularly bad for the monkey business.

“We can’t find any rhesus [monkeys] any longer. They’ve completely disappeared,” Mark Lewis, the CEO of contract research firm Bioqual, told the magazine.
Rhesus monkeys are most widely used in research, according to The National Primate Research Centers.

The monkey deficit can be attributed to the fact that the virus crisis has created a massive demand for the animals, coupled with a drop in supply from China, the news outlet reported.

China provided 60 percent of the nearly 35,000 monkeys imported to the US last year but shut off exports after COVID-19 hit.

Making things even harder, monkeys that are infected with COVID-19 have to be kept in Animal Biosafety Level 3 labs — and the US has a limited amount of those kinds of labs.

Van Rompay told the mag he gets an influx of calls weekly from companies looking to test COVID-19 treatments at his California research center, which is sponsored by the National Institutes of Health.
OBESITY CAN INCREASE CORONAVIRUS-RELATED DEATH RISK BY ALMOST 50%, REPORT SAYS
“I have to tell them, ‘I’m sorry, we are not allowed to start your research,’” he said.

The NIH is now deciding which studies can use national primate centers under a public-private initiative called Accelerating COVID-19 Therapeutic Interventions and Vaccines, The Atlantic reported.
Monkeys account for about 0.5 percent of the animals used in US biomedical research, but they typically come into play in the key last step before human clinical trials, according to the Atlantic.