Category: Covid-19 Vaccine

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EU reviewing Pfizer-BioNTech COVID-19 vaccine in real time – Reuters

October 8, 2020

(Reuters) - The European health regulator is reviewing a COVID-19 vaccine being developed by Pfizer PFE.N and BioNTech 22UAy.F in real time, days after launching a similar assessment process for AstraZeneca's AZN.L vaccine.

The European Medicines Agency (EMA) said on Tuesday its human medicines committee was evaluating the first batch of data on the vaccine, and would continue to do so until enough data is available for a final decision. (bit.ly/34mAHiI)

Pfizer and BioNTech said in a joint statement the start of the review is based on data from laboratory and animal testing, as well as early testing on humans, while continuing talks to submit data as it emerged.

The EMA is using rolling reviews to speed up evaluations of vaccines during the pandemic by studying data as it is submitted, rather than waiting for all data to be made available along with a formal application.

Last week, it began reviewing AstraZeneca and Oxford Universitys vaccine, AZD1222 or ChAdOx1 nCoV-19, increasing chances of the British vaccine becoming the first to be approved in the region for the disease which has killed more than a million people globally.

While AZD1222 uses a weakened version of a chimpanzee common cold virus to build immunity against COVID-19, Pfizer and BioNTechs vaccine, called BNT162b2, uses ribonucleic acid, a chemical messenger that contains instructions for making proteins.

When injected in people, BNT162b2 instructs cells to make proteins that mimic the outer surface of the novel coronavirus, which the body recognizes as a foreign invader and mounts an immune response against it.

Pfizers vaccine is currently being evaluated in late-stage studies in the United States, Brazil, South Africa and Argentina.

Reporting by Pushkala Aripaka in Bengaluru; Editing by Saumyadeb Chakrabarty and Shounak Dasgupta

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EU reviewing Pfizer-BioNTech COVID-19 vaccine in real time - Reuters

How Airlines Are Preparing To Ship The COVID-19 Vaccine – Simple Flying

October 8, 2020

As the world edges closer to finalizing a COVID-19 vaccine, some airlines are already preparing to ship them. To ensure distribution efforts run efficiently, carriers are readying essential facilities like cold storage and cargo planes for when the time comes.

This comes despite very little information on where vaccines will be manufactured, and what temperature they need to be kept at. Nonetheless, after the IATA last month warned carriers and authorities of the pressing need for preparation, many are now taking action.

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Korean Air has detailed its preparations to transport the vaccine once it becomes available. The airline has formed a vaccine transport task force to lead its efforts. Cold storage facilities are being prepped to store vaccines, essential equipment stockpiled and security measures fine-tuned.

Technological innovations including temperature-controlled shipping containers will make the task easier for airlines. United Cargo became the first US-based airline to lease these containers back in April.In August, Russian Airline AirBridgeCargo trialed cargo flights to gauge its readiness in transporting vaccines.

Airports are following suit by getting involved in the preparation work, with Amsterdam Schiphol Airport forming its own task force. Current preparations involve planning for four different temperature scenarios, dependent on how cold vaccines need to be stored.

Frankfurt Airport has also been preparing its cargo facilities for the eventual rollout of a vaccine. This includes over 12,000 square meters of temperature-controlled facilities and 20 transporters capable of maintaining cold temperatures.

Once a COVID-19 vaccine is cleared for global use, distribution will be the most difficult task. Many planes are currently grounded and will take months to get back into service, slowing the distribution efforts. Additionally, pre-existing vaccine programs for other diseases have already suffered from the impact of the pandemic.

Most vaccines must be kept somewhere between 2 to 8 degrees Celsius, so cold storage facilities are absolutely essential. In some cases, vaccines need to be stored at temperatures as low as -70 degrees Celsius. Without operational cargo planes and adequate storage facilities, vaccine distribution will grind to a halt.

The logistical task of transporting vaccines worldwide is one of the most challenging obstacles the industry will ever face. Pharmaceutical and aviation leaders agree that a large bulk of vaccines will need to be shipped by air. IATA director general Alexandre de Juniac commented:

Even if we assume that half the needed vaccines can be transported by land, the air cargo industry will still face its largest single transport challenge ever.

The IATA has even gone on record to say 8,000 Boeing 747 freighters will be needed to transport a sufficient number of vaccines. The unprecedented logistical task is even more difficult given the current state of the aviation industry. According to de Juniac:

If borders remain closed, travel curtailed, fleets grounded and employees furloughed, the capacity to deliver life-saving vaccines will be very much compromised.

Will global vaccinations lead to a resurgence in the aviation industry?

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How Airlines Are Preparing To Ship The COVID-19 Vaccine - Simple Flying

More than a third of Michigan voters say they won’t get vaccinated against COVID-19 – The Detroit News

October 8, 2020

More than a third of Michigan voters say they will not get vaccinated against the coronavirus, even if the measure is federally approved and recommended by their doctor, according to a Detroit News/WDIV-TV poll.

When asked if they would take a vaccine approved by the Food and Drug Administration, 39% said they would not; 44% indicatedthat they would and the remainder were unsure.

While drugmakers are trying to develop a vaccine against the coronavirus, at least one-third of Michigan voters said they wouldn't get vaccinated if the federal government approved an antidote to the virus, according to a Detroit News-WDIV poll.(Photo: Associated Press)

When asked if they would get inoculated if recommended by their physician, 34% still said they would not; 55% said they would.

The substantial numbers who said they would not get vaccinated signals an uphill climb for the state to convince residents that an approved vaccine is both reliable and important for public and personal health.

Its going to be a tough sell unless we have very solid data on the vaccine, said Nigel Paneth,a distinguished professor in Michigan State Universitys Department of Epidemiology & Biostatistics. I hope and think we will have solid data, but it will take some time.

The poll of 600 likely Michigan voterswas conducted with live operator interviews throughout the state. Half of those were reached by cell phone. Conducted by Lansing-based Glengariff Group, the poll had an error margin of plus or minus 4 percentage points.

Read the survey: How Michigan voters feel ahead of the Nov. 3 election

Of those surveyed, Democrats were more likely than Republicans to accept the vaccine, men were more likely than women and whiteswere more likely than Blacks.

I think there is a partisan difference were seeing, said Richard Czuba, founder of Glengariff Group.Were seeing reluctance on the Democratic and independent side because they see it as being rushed right now. Were seeing reluctance on the Republican side because they dont see the virus as a serious threat.

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Individuals over 50 years old were far more likely to say they would get the vaccine than younger voters.

And 47% of whitessaid they would get avaccine, compared with only 26% of African Americans, despite the fact that pre-existing health conditions more prominent in the Black population make them more likely to suffer severe cases of the disease.

"We have a consistent one-third of the population that is going to have true reluctance to this," Czuba said.

The mistrust of a vaccine is likely a symptom of three forces, Paneth said: A general opposition to vaccines in any form, anxiety about political pressure rushing the drugs approvalor the belief that the virus isnt enough of a threat to merit a vaccine.

Tom Leagon of Hudsonville said he would not get vaccinated, citing worries about the speed at which the immunizationsare being developed.

You cant just push out a vaccine, said Leagon, 49, who was among those who responded to the poll. Even with all the technology we have, it is a completely different type of vaccine we need that needs a little more time, more case studies.

Victoria Gray of Clinton has always received her vaccines and encouraged her children to get them, but shes not likely to sign up herself or children for a coronavirus vaccine under President Donald Trump.

I would prefer to probably be inoculated under someone else, Gray said.I understand its a long process. It takes time. And Ive never really heard of anything being proven this quickly. The current president scares me, and I do not trust him.

The fears came as the FDA on Tuesday laid out safety standards for manufacturers of COVID-19 vaccines after their release was initially blocked by the White House. In documents posted on its website, the FDA said vaccine manufacturersshould follow trial participants for at least two months to rule out safety issues before seeking emergency approval.

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The requirement will almost certainly delay availability of any vaccine until well after theNov. 3 election.

Alyssa Kogut of Holt said she trusts the FDA will go through the proper procedures to verify the vaccine's effectiveness and safety. And the 32-year-old has had enough experience with COVID-19 to believethat vaccination is necessary.

Her aunt died of the virus and her uncle was hospitalized with coronavirus. Kogut has diabetes and her daughter has asthma.

This is a pandemicand we need to stop it, and if everybody would get vaccinated, it would definitely help stop it, Kogut said. I would hope people take that to protect us and especially kids.

Ongoing mistrust of the vaccine options could signal trouble in vaccinating enough people to make a difference in Michigan, MSU epidemiologist Paneth said.

If 10% of the states population naturally has developed some sort of immunity to the virus, the state would need more than an additional 44% of the population to bevaccinated to reach herd immunity, Paneth said.

What herd immunity means is that you have enough immunity that cases are sporadic and spread out, he said. It doesnt reduce the caseload to zero. Youll still have cases, but you probably wont have outbreaks like we're seeing now.

When asked last month if she was considering mandating vaccination against coronavirus,Gov. Gretchen Whitmer said it was too early to contemplate that and argued there was concern that the White House would unveil one as an Election Day gimmick.

Any sort of positions around a vaccine that come from the federal government I think are going to be inherently challenging, Whitmer said. And thats why its got to be done right, it has to have efficacy,has to be supported by the appropriate testing so people have confidence that this is something they want to put into their bodies.

In March, University of Michigan Law Professor Nicholas Bagley wrote in a blog post on the Incidental Economist that under state law, the Michigan health director could conceivably order residents to get the vaccine if doing so was necessary to protect the broader public health.

Shortly after writing the article,but before it was posted, Bagley was hired as part of Whitmers legal team and served in therole through Aug. 7, according to the governors office.

On Tuesday, Bagley said he neither advised nor had conversations with the Whitmer administration about vaccines, noting it would have been inappropriate without a valid vaccine on the market.

I was writing that in my capacity as a law professor in thinking through what you could potentially do back in March, Bagley said. I have heard zero indication that this was under any kind of discussion.

The state health departments epidemic authority is broad, but a vaccine mandate would be pushing up against the edges of what the law permits," he said.

Public trust and ease of access to the vaccine both financially and logistically probably will be more important to the vaccines success in the future, Bagleysaid.

eleblanc@detroitnews.com

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More than a third of Michigan voters say they won't get vaccinated against COVID-19 - The Detroit News

Alabama preparing for mass immunization effort when COVID-19 vaccine approved – WKRG News 5

October 8, 2020

HUNTSVILLE, Ala. As medical professionals across the globe race to create a COVID-19 vaccine Alabama is preparing to roll out immunization across the state once its ready.

Dr. Karen Landers, spokesperson for the Alabama Department of Public Health says the state still does not know which vaccine product or products will be approved.

While ADPH waits, the agency is drafting a mass vaccination operational plan that will be sent to the Centers for Disease Control and Prevention.

ADPH is working with community vaccinators to make sure people have access to the vaccine once it is available. She says those partners include doctors offices, hospitals, and pharmacies.

Landers says the state has never conducted mass vaccination to the level they are expecting to see when the COVID-19 vaccine becomes available. She says the state does have some experience with mass vaccination using drive-through influenza clinics. She says flu clinics are currently being used as a trial run for COVID-19 immunization.

Our staff again is exercising with influenza vaccine by being able to, again, just refine the process. Go through the processes we have before and see if there are other measures that we need to take in order to carry out a satisfactory mass vaccination campaign, Landers said.

Landers says after the vaccine is approved it will first be available for people who are most at risk for the virus. She says that will be based on their occupation. She said people like first responders and medical personnel will be some of the first to get the vaccine.

Landers says there will be a delay before it is to released it to the general public. She did not know how long that could be, but quoted Dr. Anthony Fauci when she said sometime in mid 2021.

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Alabama preparing for mass immunization effort when COVID-19 vaccine approved - WKRG News 5

Australia expects COVID-19 vaccination is still a year away – ABC News

October 8, 2020

By

ROD McGUIRK Associated Press

October 7, 2020, 7:04 AM

3 min read

CANBERRA, Australia -- Australia considered a rollout of a coronavirus vaccine no sooner than mid-2021 a best-case scenario in its pandemic planning that would save the economy tens of billions of dollars, the treasurer said on Wednesday.

The Treasury and Health Departments developed economic modelling based on an assumption that a vaccine would be widely available in Australia toward the end of next year, Treasurer Josh Frydenberg said.

These are very uncertain times and as a government, we have taken every step possible to give Australia the best possible chance of getting a vaccine, Frydenberg told the National Press Club.

Treasury modelling doesnt contemplate a vaccine becoming available in Australia early next year. An early vaccine is regarded as one that is rolled out from July 1, providing certainty to households and businesses while promoting consumption and investment.

This so-called upside scenario also assumes that international students would return to Australian universities late next year due to the vaccine. Hundreds of thousands of students from overseas have made the Australian universities sector one of the nations biggest earners of foreign currency.

The scenario would boost Australian economic activity by 34 billion Australian dollars ($24 billion) above the current forecast in the June quarter of 2022. Economic growth would be 1.5 percentage points higher in the 2021-22 fiscal year than the 4.75% currently forecast.

Researchers are working on developing more than 170 potential COVID-19 vaccines. A June survey of 28 mostly U.S. and Canadian vaccinology experts published in the Journal of General Internal Medicine found most were pessimistic a vaccine would be available before mid-2021, but thought September or October was achievable.

Frydenberg on Tuesday announced a raft of pandemic measures that would create a record AU$214 billion ($153 billion) deficit in the current fiscal year. Based on the assumption that a vaccine will become available closer to the end of 2021 than July, annual deficits are forecast to shrink in the next fiscal year and beyond.

Were all hopeful ... that we will find a vaccine, and we have made that assumption based on the end of next year, but obviously as there are developments in the health and the global community, well continue to update our position, Frydenberg said on Wednesday.

There is a great deal of uncertainty in this pandemic, he added.

Australia has allowed for an earlier vaccine rollout with doses manufactured locally under deals struck with two pharmaceutical companies.

If trials prove successful, the University of Oxford/AstraZeneca and the University of Queensland/CSL will provide more than 84.8 million vaccine doses for the Australian population, almost entirely manufactured in Melbourne, with early access to 3.8 million doses of the University of Oxford vaccine in January and February 2021.

The government has committed to make any vaccine available for free to Australia's population of 26 million.

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Australia expects COVID-19 vaccination is still a year away - ABC News

The COVID-19 Vaccine Protest Movement Is Far Ahead of the Vaccine Itself – VICE

October 8, 2020

Demonstrators dressed as Chancellor of the Exchequer Rishi Sunak and Bill Gates in prison uniforms take part in Unite for Freedom rally in Trafalgar Square to protest against the restrictions imposed by the Government to control the spread of coronavirus, September 26, 2020. Photo via Getty Images.

Today Berlin is again the front against totalitarianism, Robert F. Kennedy crowed on a warm and surreal August day in Berlin. The longtime environmental activist turned vaccine critic regarded a crowd of around 38,000 which hed previously claimed would number a million or moreand regaled them with dubious claims. Governments love pandemics, he assured the crowd, because theyre used to impose tools of global control that the populace would otherwise never accept. The COVID-19 pandemic, he claimed, was being used as a cover to get the populace to accept both 5G technology, which Kennedy regards as a tool of the nefarious global surveillance state, and digital currency, which is the beginning of slavery.

None of that is provably true or falls anywhere other than on the distant fringes of the kingdom of reality. But as Kennedy spoke before a crowd of tens of thousands of Berliners, they were on the front lines of something both new and disturbing.

In the immediate sense, the rally was protesting lockdown measures meant to fight the spread of COVID-19. But Kennedy and other campaigners have also been busy building international coalitions for another, even bigger cause: opposing a COVID-19 vaccine before it ever appears. Worse, theyve been inadvertently aided by a complicated mix of factors, including religious and political instability, that have made people in many countries more distrustful of vaccines than ever, at precisely the wrong time. Two recent studies have found anti-vaccine sentiment has been on the rise in many countries since 2015, at the same time that anti-vaccine social media groups have been coalescing around a single, highly persuasive argument. Taken together, those forces look like an energetic, growing, and incredibly dangerous global anti-vaccine movement, at the exact time when the world needs to be persuaded to accept a new vaccine.

According to Kennedy, that summer Saturday represented a day of peaceful, high energy rallies around the world, devoted to high-flown concepts like medical freedom and bodily autonomy. (The same weekend, he also announced the launch of Childrens Health Defense Europe, a new arm of his American anti-vaccine organization.) The two most highly publicized rallies were also conspiracy theory bonanzas. As the Daily Beast reported, Kennedy was in Berlin at the behest of Querdenken 711, a German group that appears to support QAnon. The rally was also backed by far-right extremists; while the larger rally was largely peaceful, a small group of those extremists attempted to push through a police cordon later in the day and storm the Reichstag.(In a jawdropping Instagram post, Kennedy dismissed that incident as a staged incident where 100 riot police colluded in a false flag show with some 50 agents provocateurs in Nazi regalia.)

Meanwhile, protesters in Londons Trafalgar Square also called for lockdown restrictions to be lifted and protested; among the speakers was conspiracy star David Icke, best known for his belief that a shapeshifting reptilian elite race known as the Anunnaki dominates world affairs. Icke spoke about the dangers of fascism, as he called the COVID-19 lockdown measures, alongside Piers Corbyn, brother of former Labour Party leader Jeremy Corbyn. Piers has claimed that COVID-19 is a cover for enforced vaccination and seizing of you and your property.

But while the London and Berlin rallies and their colorful personalities dominated the headlines, the real face of the anti-coronavirus vaccine movement might better be found in South Africa, where anti-vaccine protesters marched through Johannesburg in July. They were protesting something far more earthbound than reptilians or the hidden dangers of 5G: a clinical trial in South Africa of the COVID-19 vaccine being developed by Oxford University. Its one of two clinical trials for potential coronavirus vaccines currently underway in Africa, part of a broad effort to make sure vaccines are made available to Africans, who are often last in line for life-saving medical innovations. Researchers have said that the tests will, in the words of the Lancet, provide important information on how the vaccine performs in populations that have the most need of protection from COVID-19. South Africa has the highest rate of infections on the continent and the tenth highest in the world; deaths there have now exceeded 17,000.

The trials have tapped into a lingering unease about the long, sordid history of medical experimentation on Black people, particularly in Africa. Earlier this year, a French doctor named Jean-Paul Mira, the head of the urgent care unit at Paris Cochin Hospital, said in a television interview, If I could be provocative, shouldnt we do this study in Africa where there are no masks, treatment, or intensive care, a little bit like we did in certain AIDS studies or with prostitutes? He added, We tried things on prostitutes because they are highly exposed and do not protect themselves.

Though Mira later apologized for his remarks, they contributed to a strong sense that the rest of the world treats Africa as a dumping crowd, in the words of the Johannesburg protest organizer Phapano Pasha. The people chosen as volunteers for the vaccination, they look as if theyre from poor backgrounds, not qualified enough to understand she told the Associated Press. We believe they are manipulating the vulnerable. The Johannesburg protesters carried placards reading We are not guinea pigs, according to Reuters, and one suggested that the vaccine be tested first on members of parliament and ministers children, not on poor people." (The same sentiment was shared by a Black tenant in a public housing complex in Pittsburgh recently, according to the New York Times: I wont be used as a guinea pig for white people, they said.)

Pasha, who didnt respond to a Facebook message from VICE News, has written that she distrusts the role the Gates Foundation plays in South Africa. Bill Gates Foundation & Clinton Foundation have been in the country for decades. Call me crazy but I don't think the upsurge of young black boys becoming gays is innocent, she wrote in August. Scientists just like politicians can be bought & pharmaceutical companies have created more diseases than cures.. We don't know the side effects of the vaccines, medicine and food we eat.

Pasha is connecting two arguments, both equally false but highly persuasive: the idea that vaccines are broadly unsafe or often have unknown side effects, and the idea that they are forced through manipulationor outright forceonto an unwitting populace. That sense of distrust means that any attempt to get a large number of people vaccinated, either through a mandate or through clinical trials, will likely be met with extreme suspicion.

The argument that vaccines infringe on peoples civil liberties and right to self-determination is one thats been pushed with increasing success on Facebook, one of the biggest and most effective sources on the internet for anti-vaccine misinformation. It also predates COVID-19 by several years, meaning it's had time to gain strength and footing.

Certain arguments are more plausible to some audiences than others, says David Broniatowski, a researcher and associate professor at George Washington University, and a lead author on a new study published on October 1 in the American Journal of Public Health. The researchers found that Facebook groups discussing vaccines as a civil liberties violation have ballooned massively in the past few years, especially after a 2015 measles outbreak at Disneyland, the release of the influential anti-vaccine film Vaxxed in 2016, and a global measles outbreak in 2019. After each event, the researchers saw anti-vaccine discourse coalescing more and more around the idea that refusing to vaccinate is a civil right.

The strength of a civil liberties-based argument, Broniatowski said, is that you dont have to argue the scientific facts. Instead, the conversation becomes about both personal agency and trust. The debate is about, if youre free to choose, do you really trust this person? It gets right to the core of what vaccination is all about for most people"the choice, he argues, to trust medical experts and vaccine science itself.

Even extremely educated people who arent trained in immunology wouldnt know how vaccines work or read the papers or reviewed the data," he said. "So much of it comes down to whats your perception of the expertise of the person who says these are safe. The only way this works is you have to trust the institutions.

Trust in institutions is, of course, in short supply across much of the world right now: The surge in populism is also explicitly positioned as a movement against elites and elite institutions. All of that dovetails together with the argument that vaccines are a tool of the elite, being forced onto the people. After the global 2019 measles outbreaks, Broniatowski said, all forms of anti-vaccine content on Facebook saw an uptick, but civil liberties content has a huge spike. It massively increases. People started to talk about and get scared of vaccine mandates.

While they were tracking Facebook pages in English and focused on the U.S., he said, they also monitored impassioned discussions about vaccine mandates in many different countries, including Australia, the U.K., and Italy. All these things play together, theyre all feeding off each other, he says. Vaccine mandates and controversies in different countries are eagerly showcased to show What Could Happen Here.

It also builds on decades of propaganda, Broniatowski adds. For example, Soviet propaganda like Operation INFEKTION was based on the idea that the US was trying to unleash viruses on unsuspecting underdeveloped countries at some point. So I think that all of this plays together. Theres absolutely a history here.

That history continues to inform the present. Another large retrospective study recently published in The Lancet mapped confidence in vaccines across 149 countries. Between November 2015 and December 2019, the authors wrote, we estimate that confidence in the importance, safety, and effectiveness of vaccines fell in Afghanistan, Indonesia, Pakistan, the Philippines, and South Korea. We found significant increases in respondents strongly disagreeing that vaccines are safe between 2015 and 2019 in six countries. All of them are politically unstable and facing rising tides of religious extremism: Afghanistan, Azerbaijan, Indonesia, Nigeria, Pakistan, and Serbia. In August, a particularly significant tidbit of fake news began to spread on social media, claiming that COVID-19 vaccinations were being made mandatory in Serbia for children, and falsely claiming that the mass protests were underway.

MILLIONS OF SERBIANS Took to the streets of Belgrade in protest! one post read. They will NOT be forced into a bullshit vaccination!

Marginalized groups, including religious minorities, tend to be less trustful of institutions, Clarissa Simas told VICE News. Shes a psychologist and research fellow for the Vaccine Confidence Project, an interdisciplinary group of researchers who study trends in vaccine confidence worldwide. Shes also one of the authors on the Lancet study. The irony is that in many countries, the populations suffering the heftiest burdens from COVID-19 and other health challenges are the ones least likely to trust institutions.

In Simas perception, the dipping rates in vaccine confidence in many countries can be best countered not by stressing how safe vaccines are, but by building a broader kind of trust.

As humans, the way that we perceive risk and danger isnt necessarily attuned to what real risk and danger is, she said. Telling someone that a vaccine is safe or well-tested doesnt necessarily mean theyll perceive it as safe. As a psychologist, Simas thinks theres more value in helping build broader trust in health institutions. What does make a difference is people knowing that a health institution is for the greater good and not for self-interest. Thats more worthy of investing, but trickier at the same time.

Restoring confidence in health and government institutions will require a massive investment in grassroots work, she adds, and will require governments and health professionals to listen as much as they talk. Attention to community engagement, and listening in every part of the world, is going to be fundamental.

Thats going to be especially important to counter the message that anti-vaccine groups have been so diligently building: that vaccines are being forced on populations by the government, or by some hostile outside group. Bill Gates and the Gates Foundation, for instance, are the focus of intense amounts of conspiracy theorizing because of their investment in vaccine research. Even clearly fake videos implicating Gates in a vaccine conspiracy of some kind have gone mega-viral since the start of the pandemic.

That will need its own special attention, Simas said. If it is a foreign vaccine or a Gates Foundation vaccinean alien vaccine, lets put it like thatthe endorsement of a [local] government or public health authorities endorsement, as well as clear communication about that vaccine, can make a lot of difference.

Looking at these two studies, it seems obvious that various shades of distrust are coalescing rapidly into a global movement of vaccine suspicion, precisely shaded in different countries to fit local and national concerns, at exactly the time we can least afford it. The situation, however, isnt hopeless, according to Simas. The main takeaway of the paper and what our findings show globally is were not in a downward spiral she told VICE News. What were seeing now is that confidence goes up and down. Even the most worrisome trends, she argues, are reversible.

As of mid-September, though, a U.S.-based study has shown deep division in whether people say theyll get a coronavirus vaccine, when one appears, and its reasonable to think the same will be true in many other places. Can we possibly build institutional trust globally fast enough to get most of the world to accept a COVID-19 vaccine, when one appears?

That, Simas said, is the million dollar question. While she doubts its even remotely possible to get the vaccine to everyone on the planet, we want to have a good chance of having an optimal coverage. Its fundamental to do this community and grassroots engagement. That means paying attention to the groups that are more vulnerable and might need some extra push.

Building trust in health officials and governments isnt easy at the best of times. It seems obvious that the challenges now will be exponentially greater in the face of a frighteningly uncertain illness and an increasingly organized and powerful anti-vaccine movement, especially with the worlds most powerful leaders sending bizarre and dangerous messages undercutting public health authorities' warnings about the dangers of the disease.

Robert F. Kennedy Jr. seems to be banking on the power of a global movement, even as hes begun claiming that his viewpoints are being shadowbanned or censored on social media. (Instagram recently began putting a content warning on some of his posts that contain false information.) A few weeks ago, he approvingly shared a mural by an Australian street artist: a leering Bill Gates, syringe in hand, next to the words Time to install your update. Australia, Kennedy wrote, was the new battleground to watch in the global devolution from democracy to medical fascism.

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The COVID-19 Vaccine Protest Movement Is Far Ahead of the Vaccine Itself - VICE

Moderna CEO says COVID-19 vaccine will be ready for FDA submission in late November – PMLiVE

October 6, 2020

Modernas chief executive officer Stphane Bancel (pictured above) said that he expects Moderna to be ready to submit its COVID-19 vaccine candidate to the US Food and Drug Administration (FDA) in November.

Bancel revealed the possible timelines for approval and availability of the companys mRNA-based COVID-19 vaccine candidate at the US Pharma and Biotech Conference hosted by the Financial Times last week.

He added that he expects the Moderna vaccine will be ready for use in late March or early 2021, with the aim of submitting the candidate to the FDA for emergency use authorisation on 25 November 2020.

Beyond an emergency use authorisation, Bancel said that Moderna will not be ready to submit its vaccine to the FDA for a Biologics License Application (BLA) until at least late January 2021.

If its BLA is approved, Moderna will be able to launch its vaccine within the general population, meaning the shot will be available for wide-scale use.

"25 November is the time we will have enough safety data to be able to put into an EUA file that we would send to the FDA, assuming that the safety data is good, ie, a vaccine is deemed to be safe,"said Bancel, according to theFinancial Times.

"The EUA, we think, will be an important medical tool to start addressing people at very high risk, like healthcare worker[s], like the elderly," he added, according to CNN.

In July, Modernas COVID-19 vaccine mRNA-1273 entered a late-stage phase 3 clinical trial, evaluating the shot on 30,000 study participants.

Interim analysis from the phase 1 study of mRNA-1273 was published in early July, demonstrating that the vaccine produced rapid and strong immune responses against SARS-CoV-2 in all participants tested.

Following two doses with the vaccine, neutralising antibody levels among participants were similar to those seen in individuals who had tested positive and recovered from COVID-19.

Last month, Moderna also revealed results from the phase 1 study, which showed promise in older adults, with adults aged 56-70 and aged 71 years and older exhibiting a strong immune response and similar levels of neutralising antibodies compared to younger participants.

Bancel previously told Business Insider that the company would most likely know in November whether or not its COVID-19 vaccine works, supporting the most recent timeline projection.

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Moderna CEO says COVID-19 vaccine will be ready for FDA submission in late November - PMLiVE

5 Things to Know About a COVID Vaccine: It Won’t Be a ‘Magic Wand’ – Kaiser Health News

October 6, 2020

President Donald Trump makes no secret he would like a COVID-19 vaccine to be available before the election. But its doubtful that will happen and, even after a vaccine wins FDA approval, there would be a long wait before its time to declare victory over the virus.

Dozens of vaccine candidates are in various testing stages around the world, with 11 in the last stage of preapproval clinical trials including four in the U.S. One or more may prove safe and effective and enter the market in the coming months. What then?

Here are five things to consider in making vaccine dreams come true.

1. A vaccine is vital in fighting the virus, but it wont be a quick pass back to our old lives.

Vaccines have helped rid the world of scourges like smallpox, but the process takes time and there are no guarantees. Until clinical trials have been completed on this first round of vaccine candidates, no one knows how effective they might prove to be.

The minimum requirement by the Food and Drug Administration for any COVID-19 vaccine is that it should at least prove 50% effective when compared with a placebo that is, a neutral saline solution.

By comparison, the annual influenza vaccine ranges between 40% and 60% effective in preventing the illness, depending on the recipient and the season examined. In contrast, a full course of the measles vaccine is about 97% effective.

Its very unlikely that a first-generation vaccine will be something like a measles vaccine, notes Dr. Amesh Adalja, a physician with expertise in infectious diseases and senior scholar at the Johns Hopkins University Center for Health Security.

2. After vaccines gain approval, the real-world evaluation ensues.

Vaccines undergo a protracted testing process involving thousands of subjects. They win FDA approval only after they demonstrate safety and meet at least the minimum standard of effectiveness. Monitoring continues after they hit the market; effectiveness and any rare side effects or safety issues become more apparent after millions of doses are given.

Hypothetically, lets say the first new COVID vaccines prove 70% effective at preventing the disease. That would mean seven of every 10 people who roll up their sleeves will be protected, but three will not.

While thats good news for those protected, questions remain about who is covered and who is still vulnerable. Its possible, Adalja said, that the vaccine would reduce the severity of disease in the remaining three people, thereby helping cut hospitalizations and severe side effects.

But its also true that regulators are focused on whether a vaccine prevents disease. Some vaccines can keep you from getting sick without preventing infection, in which case you could still spread the virus even without exhibiting symptoms.

Mysteries remain, at least for now. Scientists dont know how long the protection will last, for instance. Will protection fade, requiring annual shots, as with influenza? Or will it last for years?

Also, the COVID vaccine candidates are being tested only in adults so far. Most vaccine makers have delayed testing among children or pregnant and breastfeeding women, for example. That could mean an initial lag in safety and efficacy data for those groups, complicating vaccination efforts for children or even front-line health care workers, many of whom are women of childbearing age.

For all those reasons if you are looking for a magic wand, you wont find one in vaccines, said Dr. William Schaffner, a professor of preventive medicine and infectious disease at Vanderbilt University Medical Center in Nashville, Tennessee. That said, vaccines will play a substantial role in reducing the epidemic.

3. After a vaccine is approved, you still may need to wait awhile to get your shot.

Making vaccines is complicated. And so is distributing them. Vaccine makers say they are already producing vaccine in advance of knowing whether they will win approval. But simply having ample vaccine supply doesnt mean manufacturers will have all the needed glass bottles, syringes or injectors to ship them right away. Indeed, some experts fear that a shortage of both production-line capabilities (special facilities are needed to make vaccines under strict sterile conditions) and limited supplies could hamper distribution of an approved vaccine. Many of the vaccine candidates must be shipped and stored at super-low temperatures, adding to the complexity.

Even if you have the vaccine, that doesnt mean you can ship it out. There are multiple, multiple steps, and all of them have to work, said Dr. Ezekiel Emanuel, a vice provost at the University of Pennsylvania who has warned of potential shortages.

The Centers for Disease Control and Prevention and the National Academy of Sciences have issued a framework for who should get priority for the initial vaccine. State and local health departments will also have a say in how supplies roll out.

Current recommendations say first in line will be health care workers and people with medical conditions that put them at highest risk if they get the virus. People living in nursing homes and other congregate settings will also be higher on the list. Further down are average healthy adults.

Pay attention, and go when its your turn, said Schaffner.

If they say its time for people who are middle-aged and have chronic underlying illness such as diabetes, heart disease and lung disease, you have to know what you have and understand its your turn, he said. You also have to understand if its not your turn yet. Be patient.

Finally, many of the vaccines under consideration will require two doses spaced a few weeks apart, which would add to the delay. If more than one vaccine is approved, which is likely, people will need the second dose to come from the same manufacturer as the first. That could prove a record-keeping nightmare and lead to more delays depending on how vaccine supplies hold up.

In testimony before Congress in mid-September, CDC Director Robert Redfield said that tens of millions of doses of vaccine may start to become available by late November or December. But the logistics of vaccine distribution means the country wont be able to return to regular life until late second quarter, third quarter 2021, Redfield predicted.

4. So dont throw out your masks yet.

Because any vaccine is likely to fall short of 100% effectiveness and wont be in widespread distribution for a while, the use of masks and maintaining social distance will be required well into next year, experts say.

The vaccine will be a start, but well still need to do the things weve been discussing throughout hand hygiene, wearing masks and continuing to remain specifically distant, said Dr. Krutika Kuppalli, an assistant professor of infectious disease at the Medical University of South Carolina. Those are the arsenal of tools we will need to use.

5. What if I dont want to get vaccinated?

Polls show a good percentage of Americans either dont want a vaccine or want to wait a bit before getting one. Can they be required to get a shot?

Certain employers, such as hospitals or food production plants, could require their workers to be vaccinated, but a federal mandate is highly unlikely and probably would be unconstitutional, said professor Dorit Rubinstein Reiss, an expert on employer and vaccine law at the University of California-Hastings College of Law.

The likely approach of public health authorities is to educate people about the benefits and potential side effects of a vaccine down to whether one might experience a sore arm.

Thats what we do for every vaccine, said Adalja of Johns Hopkins. A requirement of vaccination for the general public would create resistance and foster conspiracy theories, he said.

Most regulation of public health falls to state and local governments and health agencies, Reiss said. States would be more likely to have narrow or specific mandates that could survive judicial review, she said.

Schools, of course, require students to be vaccinated against a wide range of illnesses. But a school-age COVID vaccine mandate is doubtful, at least in the near term, because the vaccine hasnt been tested on school-aged children.

Generally speaking, employers, including the federal government, have the power to require vaccinations, especially if they dont have a unionized workforce with a contract that might limit their power. All employers, however, face limits set by civil rights and disability laws and may have to provide alternatives for people who cant or wont get vaccinated, Reiss said.

Read more from the original source:

5 Things to Know About a COVID Vaccine: It Won't Be a 'Magic Wand' - Kaiser Health News

Novartis CEO: A vaccine will not magically save us from COVID-19 – Fast Company

October 6, 2020

There will be no silver bullet that brings COVID-19 to an endnot even a vaccine, said Novartis CEO Vas Narasimhan.

During a conversation with Fast Company Editor-in-Chief Stephanie Mehta, the chief executive of the pharmaceutical giant laid out how he thinks the global health system failed and why hes optimistic about the future. Part of the problem, Narasimhan said, is that the world was in a particularly vulnerable place when the pandemic hit.

Over the last decade there has been a decline in overall public health preparedness within the system in the United States and around the world, he said at the Fast Company Innovation Festival. As the investment goes down, the preparedness goes down, so I do think we were at a unique moment where we were more susceptible than we would have been a few years ago.

The CEO led Novartiss vaccine program during the 2009 H1N1 virus. He said he has seen the same mistakes repeated when a deadly disease strikes. What Ive seen consistently is the world really falls short on three dimensions, said Narasimhan. These include a lack of:

When a disease is spreading fast, public health officials must share information as soon as they have it, he said, though politics can interfere with that. World leaders always consider how such information will impact trade and the economy.

In the internet age, free-flowing information can also lead to confusion. He said social networks have made it easy to share new COVID-19 research published online. Scientists draw conclusions from an accumulation of information and replicated studies. But the general public can latch onto a single study and circulate it as ground truth. That creates a difficult environment for sending a unified public health message.

The power of social media is that it is so fast, much faster than the power of our ability to publish rigorous data, to do all the proper experiments, Narasimhan said. I think that creates this kind of perception that because something is said online it might be true or it must be true if it gets circulated enough.

Yet, he said, there have been encouraging moments during the pandemic as well. China sequenced the genome for the coronavirus early. That allowed the pharmaceutical industry to start testing out vaccine candidates. In some places, lockdown measures happened at an unprecedented scale, keeping transmission low.

Narasimhan also said the medical community was quick to repurpose existing drugs for COVID-19 treatment. Progress on COVID-19, he said, will continue to be iterative.

There will be no one thing, he said, that takes us back to the way things were. He thinks we will learn to live with this coronavirus the way we live with others: using a combination of vaccines, therapeutics, and other technologies. That means life will eventually edge close to normal: The accumulation of all the innovation thats being pursued right now will make life come back to . . . [something] similar to what weve had in the past.

More here:

Novartis CEO: A vaccine will not magically save us from COVID-19 - Fast Company

What We’re Reading: Examining a COVID-19 Vaccine; BMS Acquires MyoKardia; Heath IT in Rural Communities – AJMC.com Managed Markets Network

October 6, 2020

Five things to know on a vaccine for the coronavirus disease 2019 (COVID-19) were spotlighted; Bristol Myers Squibb (BMS) will buy heart drugmaker MyoKardia Inc for $13.1 billion; a look at the importance of health information technology (IT) in rural areas.

Kaiser Health News spotlighted 5 things to know on a vaccine for coronavirus disease 2019 (COVID-19). Among the points detailed is that a vaccine would be vital to fighting the spread of the virus, but the effectiveness of the vaccine candidates is not yet known and would require real-world evaluation as well. Moreover, the wait time in which the vaccine would be distributed indicates that current measures to curb infection, such as mask wearing, will remain a primary preventive approach.

Announced today, Bristol Myers Squibb (BMS) will buy heart drugmaker MyoKardia Inc for $13.1 billion in cash. Bloomberg reports that with this move, BMS will expand its availability of heart therapies and help diversify the company beyond oncology. Additionally, BMS will receive access to MyoKardias lead product mavacamten, an experimental drug that is designed to treat obstructive hypertrophic cardiomyopathy, in which the heart muscle becomes abnormally thick.

A report published by Forbes highlights the importance of health information technology (IT) in rural areas, especially as rural hospitals continue to struggle financially from the effects of COVID-19. Rural hospitals, like most others, experienced deferrals in elective surgeries and other types of nonCOVID-19 care due to state restrictions and patient fear. As noted in the article, health IT can keep rural hospitals thriving in the community and deliver care closer to patients homes via telehealth consultations and virtual doctor visits.

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What We're Reading: Examining a COVID-19 Vaccine; BMS Acquires MyoKardia; Heath IT in Rural Communities - AJMC.com Managed Markets Network

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