Category: Covid-19 Vaccine

The first patient enrolled in Pfizer's COVID-19 vaccine clinical trial at the University of Maryland School of Medicine in Baltimore receives an injection in May. AP hide caption

The first patient enrolled in Pfizer's COVID-19 vaccine clinical trial at the University of Maryland School of Medicine in Baltimore receives an injection in May.

Pfizer, the apparent front-runner in developing a COVID-19 vaccine for the United States, says its results won't be ready until mid-November at the earliest. That dims any lingering expectation that there could be a vaccine by Election Day, as President Trump has asserted.

Trump's hopes had been bolstered by Pfizer executives, who have said they could have clinical trial results sometime in October. Even if that were so, a pre-election vaccine would mean the Food and Drug Administration would have to give an almost immediate thumbs-up.

Pfizer Chairman and CEO Albert Bourla said in a public statement Friday that it is indeed possible the company could have enough data to know this month whether the vaccine it is developing actually protects people from coronavirus infection. But the company won't have data showing the vaccine is safe before the third week of November at the earliest.

The FDA said earlier this month that, before it reviews a coronavirus vaccine application, a company must have safety data that extends for a median of two months. That means Pfizer needs to wait until half of the volunteers in its ongoing trial have been followed for at least two months before the company can submit its material for FDA review.

"We estimate that we will reach this milestone in the third week of November," Bourla wrote.

The company has been waiting for a certain number of people in its study to come down with COVID-19. Once that threshold has been reached, scientists can analyze the data and see whether those who got sick were in the group that got vaccinated or in the comparison group, which received a dummy shot. The vaccine must reduce the risk of infection by at least 50% to be considered for FDA emergency authorization.

Polls show many Americans are hesitant about taking a coronavirus vaccine and concerned that the approval process could be driven by politics. But vaccine companies have said they won't let that happen, and Pfizer said its announcement underscores its commitment to safety.

You can contact NPR science correspondent Richard Harris at rharris@npr.org.

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Pfizer COVID-19 Vaccine Delayed Until At Least Late November : Coronavirus Live Updates - NPR

Vaxart, a California biotech firm that is attempting to develop a Covid-19 vaccine, has come under scrutiny from federal prosecutors and the Securities and Exchange Commission.

The company announced in June that it had been selected to participate in Operation Warp Speed, the U.S. governments flagship effort to develop cures and treatments for Covid-19. That sent Vaxarts stock price soaring, allowing a hedge fund that controlled the company to reap an instant $200 million profit by selling shares.

The New York Times reported the next month that Vaxart appeared to have overstated its involvement in Operation Warp Speed.

Vaxart said it had received a subpoena from the Justice Department concerning its role in Operation Warp Speed and the stock sales in July, the company disclosed in a securities filing this week.

In August, the S.E.C.s enforcement division requested documents from the company about the same matter, Vaxart said in the filing, which was reported earlier by Fierce Pharma, a trade publication.

We are cooperating with the U.S. attorneys office regarding these requests and have provided documents and information in response, Vaxart said in the securities filing. It added that it had voluntarily provided documents requested by the S.E.C. and is cooperating with this informal inquiry.

A number of shareholder lawsuits have also been brought against Vaxart, its executives and its board, accusing the company of misleading investors by overstating its role in Operation Warp Speed.

Vaxart is one of dozens of companies pursuing coronavirus vaccines. But the company, which had just 15 employees this summer, is not among the drug makers that have received substantial funding for their research and production efforts through Operation Warp Speed.

Nonetheless, the company in June issued a news release that stated: Vaxarts Covid-19 Vaccine Selected for the U.S. Governments Operation Warp Speed. That sent shares of the company soaring, and within days, a hedge fund, Armistice Capital, had sold shares worth more than $200 million.

But Vaxarts involvement in Operation Warp Speed was limited. Its vaccine candidate was one among those being tested in an animal trial sponsored by the federal initiative. Officials at the Department of Health and Human Services, which is coordinating Operation Warp Speed, distanced the department from the company, saying it was involved only in preliminary studies but had not yet won government support.

The value of Vaxart stock has fallen more than 50 percent since mid-July, when it hit new highs on the heels of its Operation Warp Speed announcement.

This week, the company said that it had begun its Phase 1 trial and that initial tests on hamsters had yielded promising results.

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U.S. Investigates Vaxarts Claims Related to Covid-19 Vaccine - The New York Times

How long will it take to protect the entire world from the coronavirus?

Only now is it becoming clear that, in the best-case scenario, it will take at least 18 months, beginning early in 2021, for vaccines to reach every part of the world where they are urgently needed.

One measure of the magnitude of the task is that to deliver a single dose of vaccine to the world population of 7.8 billion people would take the equivalent of 8,000 flights by the worlds largest cargo airplane, the Boeing 747.

The whole program depends on whether there will be enough airplanes to deliver the vaccine dosesand whether the will and means exist to build a global network able to meet the exacting standards required to keep vials of vaccine at critical temperatures, from when they leave the manufacturer to when they finally reach the places where they will be administered, no matter how far and remote.

This infrastructure involves special handling via dedicated warehouses, moving through airports where customs and border controls, a frequent choke point, must allow fast tracking, and similarly secure and dedicated ground transportation.

Make no mistake, this is truly a moonshot moment. A new global airlift for life-saving meds has to be built at a speed that has never before been accomplished. And, once more, the planning has exposed significant disparities in the resources of advanced nations and those of the underdeveloped world.

In North America, Europe, Russia, China and Southeast Asia, the means exist to rapidly ramp up supply chains and safely deliver vaccines to large populations during 2021.

In Africa, Central and South America and the Indian subcontinent, critical infrastructure will have to be created from scratch. (India has no air cargo infrastructure equal to the needs of its 1.35 billion population.)

And experts warn that even in the developed world, there are serious challenges to overcome.

At the heart of these challenges is the cold chain. This is an already well-established system that ensures that vaccines and other temperature-critical medications are maintained at precise temperatures for the entire time they spend in transit, no matter if the journey takes many days and passes through great variations in climate and handling through airports and ground delivery.

In many of the countries in Africa, Central America and South America you cannot rely on the same infrastructure for a temperature-controlled environment as you can in the developed world. For them, to create what is needed will probably require a combination of commercial and military resources.

The cold chain was initially created because vaccines to treat smallpox, measles and ebola needed to move through it in order to safely and swiftly get where they were neededindeed, the world eradication of smallpox would not have been possible without it.

This was one of the greatest leaps ever in global infrastructure in the cause of preventing needless deaths, but it is dwarfed by what confronts a world desperate to gain control of the coronavirus pandemic. The cold chain will have to be hugely expanded.

COVAX, an alliance of vaccine producers and international health agencies created to handle the pandemic, aims to produce two billion doses by the end of 2021. This assumes that all nine of the present vaccines being developed and tested in the COVAX program will prove safe and effective. (Six of them are part of the U.S. governments $6 billion Operation Warp Speed, and two of them are being developed in China.)

Expecting instant success of all of the vaccines is already a roll of the dice. As The Daily Beast has reported, the vaccines have been developed at an unprecedented speed, their long-term effects are still unknown, and testing is far from complete.

And the problem for the cold chain is that there are basically two groups of vaccines in the pipeline. One group has to be kept in very deep freeze, at a temperature of minus 112 degrees Fahrenheit, the other at between 35 and 46 degrees Fahrenheit.

This means that vaccines requiring the deep freeze will likely be confined to parts of the world where such demanding standards of the cold chain can be assured, while the others get directed to places where the handling and distribution systems will be less sophisticated and, in many cases, dont even exist yet.

Glyn Hughes, global head of cargo at the International Air Transport Association, IATA, which represents all the worlds airlines, is closely involved in planning the massive airlift. He told The Daily Beast:

There is no time to be lost. In many of the countries in Africa, Central America and South America you cannot rely on the same infrastructure for a temperature-controlled environment as you can in the developed world. For them, to create what is needed will probably require a combination of commercial and military resources.

Another gap in the coverage would be the inability to establish secure cold chain infrastructure in black hole nations like Venezuela, Yemen, Syria and Iraq, where either war or endemic corruption make it near impossible to carry out safe delivery and distribution.

And there is another specter to watch out for. In countries like Nicaragua, where Daniel Ortega has been the strongman since 2007, or the Philippines, where Rodrigo Duterte rules with an equally iron grip, there is little doubt that the ruling juntas would get priority and perhaps even withhold the vaccines from their opponents, which would amount to biological warfare.

There is also disagreement among the planners about how to phase deliveries of the vaccines, particularly if shortages occur because some vaccines fail to make it through testing.

Some argue that achieving world coverage would happen faster if, at first, only enough vaccines to cover 20 percent of the population of each country were delivered.

Others believe that it is more efficient to give full coverage to each country rather than to return later to serve the 80 percent missed in the first wave.

Even at the optimistic rate of administering a million doses a day it would take 83 days (almost three months) to cover the German population, a country with a highly developed medical infrastructure.

All of this highlights the very real risk of confusing priorities with privilege. Who would be included if only one fifth of the people could be vaccinated? Inevitably such a system would favor elites, like politicians, the wealthy, the military and law enforcement. Would frontline medical staff be included? Would those most at risk because of either their health or their age have to wait?

Alexandre de Juniac, CEO of IATA, has called the vaccine airlift the mission of the century.

Experts at international relief agencies like Gavicreated in 2000 to ensure that children get the vaccines they need and credited with having saved the lives of 20 million childrenworry that there will be an unseemly stampede in the rich world to get the vaccines while the poor world, with its weak infrastructure, gets left behind.

In addition to these challenges, there may not be enough space on airplanes to carry the vaccines.

There is a world shortage of air cargo capacity. This is due partly to the grounding of thousands of passenger airplanes that would normally carry cargo (alongside passengers luggage) in their belly holds, and partly to the pandemic causing millions of people to shop onlineand this, in turn, has swollen the competition for air cargo space on the planes that remain in the skies.

And yet the irony is that thousands of widebody jets that could be adapted for this new mission are parked at airports and airfields all over the world for lack of passengers.

Getting them back into the air wont be easy, and someone has to pony up the money to do it because most international airlines are broke. As Hughes points out, Its better to have airplanes flying than grounded, where maintaining them in the required condition is costly.

But airplanes brought back specifically for the airlift would have to fly with empty cabins.

Early in the pandemic, when there was an urgent need to fly PPE and hospital equipment where it was needed, cabins were usedsupplies were strapped to seats and even stuffed into overhead bins.

But passenger cabin climates cant be adapted to the needs of the cold chain. Vaccines will have to go into special temperature-controlled containers in the belly holdsand, even then, it will take time to provide enough of those containers.

Alexandre de Juniac, CEO of IATA, has called the vaccine airlift the mission of the century.

However, when the readers of the industry publication Air Cargo News were polled on their expectations of the airlift, only 11 percent of them felt that the industry was ready to go.

One glaring problem is the absence of a single coordinating international body able to attack all the impedimentstechnical, regulatory, diplomatic and culturalthat lie in the path of such an ambitious program.

It might seem that the International Civil Aviation Organization, the ICAO, a United Nations body, would be such a body because it is the only one that directly links commercial aviation to the governments of 193 nationsthat includes every nation that has an airline.

However, the ICAO has frequently proved unable to use diplomacy effectively with such a variety of political regimes to wrangle and has become notoriously bureaucratic and sclerotic. When asked by The Daily Beast about its role, a spokesman took most of an email to explain what they cant do rather than what they can and wrapped up by saying, The planning and allocating of air cargo capacity will therefore continue to be a management decision in the airlines concerned.

The IATA is much more proactive but they, too, have limited leverage with the airlines. They cant make the airlines spend money they dont have, and the total cost of the airlift is expected to be north of $18 billion.

They are, for example, hoping that new air corridors between continents, nations and cities would get passengers back in the air and, at the same time, generate a lot more space for vaccines in the belly cargo.

The air corridors are designed to make passengers feel safe during the pandemic. That requires all the airports to be compliant with new health and safety standardssomething that, so far, the U.S. government has conspicuously failed to support. Moreover, this plan will become harder to achieve as infection rates spike again, as they are in Europe.

The expanded cold chain will need a wide reach to include all the places where the nine candidate vaccines are being developed: the U.S., U.K.,France, Austria, China, Hong Kong and Australia.

For sure, an enormous load will fall on the worlds handful of freight-only carriers. Fedex, UPS and DHL are all upping their game and will underpin the resources of Project Warp Speed in America.

Isabel Rollison, a spokesperson for Fedex, told The Daily Beast: We have added more than 10 secure cold chain facilities across our global network. At present we have more than 90 cold chain facilities across the Americas, Asia, Australia and Europe.

To complement our existing cold chain capabilities in support of the vaccine distribution we are exploring a combination of solutions, including stationary freezers, temperature-controlled ocean containers and refrigerated trailers.

And China, the origin of the pandemic, is creating a Fedex clone. Its airlines found it hard to handle the surge of demand for PPE, ventilators and drugs in the early stages of the crisis, trying to meet both its own national needs and strenuous demands for help from abroad.

Now the State Council, the Communist Partys powerful central planning force, has demanded the consolidation of the countrys air cargo carriers. The largest of those has a fleet of only 58 freighters. Fedex alone has a fleet of 378 widebodies. The Chinese airlines are being told to follow the Fedex model and integrate their infrastructure with ground services.

Hughes believes that once the immediate urgency has passed the dependency on airlifts will be eased by addingas Fedex is obviously already planningocean shipping with cold-chain-compliant containers for longer-term readiness.

Ultimately, for the airlines, if they bring off this mammoth airlift, we could see another case of never letting a good crisis go to waste (the most spectacular example being Amazon.). The expanded cold chain infrastructure will be permanent. The coronavirus vaccine will likely become part of an annual regimen like flu shots. Other health emergencies will need the same rapid response. Air cargo is becoming a goldmine. Just look at the Fedex stock price. It has more than doubled over the last six months.

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Even When We Have a COVID-19 Vaccine, The Rollout Will Take Years - The Daily Beast

When will a COVID-19 vaccine be ready? Here's what one San Antonio doctor says...  WOAI

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When will a COVID-19 vaccine be ready? Here's what one San Antonio doctor says... - WOAI

Dr. Robert Redfield made the announcement in a discussion with SC leaders Thursday, saying state health departments have until Friday to submit a vaccination plan.

COLUMBIA, S.C. The nation's top public health official stopped by the Capital City today.

Dr. Robert Redfield, Director of the Centers for Disease Control and Prevention (CDC), joined state leaders to discuss the short and long-term effects of COVID-19 in our state.

Redfield also unveiled details on a possible vaccine plan.

"The outbreak is on the increase now and we've got to be vigilant," said Redfield during the discussion with state leaders.

Redfield stressed that the threat of coronavirus is still out there, saying what happens over the next three or four months is in the hands of the American public.

According to The COVID Tracking Project, cases are going up in 37 states. In 42 states, including South Carolina, hospitalizations are also on the rise.

"Where I am worried is the home gatherings, and we're looking at a big one coming up," said Redfield.

Thursday, Redfield commended South Carolina's response to the pandemic and applauded USC's strategy to curb the spread of coronavirus.

As of Monday, the university has an overall infection rate of 0.56%. Thursday, USC reported zero positive test results out of 499 students and faculty tested.

"Within the last four months, it turns out that the universities now are the safest place in town," said Redfield.

Also discussed Thursday among state leaders were the indirect health effects of COVID-19, such as the pandemic's effect on chronic conditions, substance abuse and mental health.

Since the pandemic began, South Carolina has seen an increase in alcohol and substance abuse.

DHEC says suspected opioid overdoses are 50% higher from January to August of 2020 compared to the same time last year.

USC President Bob Caslen said the university sends out a mental health survey every week. "20 to 25% say that they are struggling with COVID here on campus," said Caslen. "Both students and faculty."

Earlier this year, the South Carolina Department of Mental Health (DMH) and the South Carolina Department of Alcohol and Other Drug Abuse Services (DAODAS) launched a statewide support line for those in need of mental health or substance use services. 1-844-SC-HOPES connects callers to trained clinicians who can address their needs.

"Health is available and Hope is available. We say social isolation, but the key to this is staying connected in the safest way possible," said Sara Goldsby, DAODAS Director.

One of the biggest questions about the pandemic involves a vaccine. Many wonder when it will be available.

Dr. Redfield believes a vaccine will be ready to be distributed by January 1, 2021, "Which I think is really nearly miraculous," said Redfield. "When you can think within nine months we're going to have potentially one or two approved vaccines, that's something that normally takes four to six years."

States must submit their vaccine distribution plan to the CDC by Friday, October 16.

We checked with SCDHEC, who told us they're on target to have their plan submitted on time.

We requested a copy of DHEC's vaccine distribution plan. We'll let you know when we get it.

Health experts urge South Carolinians to continue to take the pandemic seriously by washing your hands, social distancing, avoiding large crowds - especially indoors - and wearing a mask.

"If we all did that, we would really control this pandemic," said Redfield. "We wouldn't eliminate it, but we would bring it back under control within 6 to 12 weeks."

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'Nearly miraculous': CDC director says COVID-19 vaccine will be ready by Jan. 1 - WLTX.com

Half a million sharks could be killed in order to save the world from the coronavirus. Buzz60

Conservationist groups are concerned demandfor a coronavirus vaccine will strainan already taxedresource: sharks.

Shark liver oil contains the natural occurring substance squalene. Scientists use squalene for adjuvants that are added to vaccines to enhance immune response and increase effectiveness.

We are in no way prioritizing sharks over human health, but we simply have to ask why more sustainable squalene sources are not being considered as an option, said Stefanie Brendl, founder of Shark Allies, a nonprofit group dedicated to the protection of sharks and rays.

In many shark species, 50% to 80% of the weight of their liver is squalene, according to Dr. Corey Casper, president and CEO of the Infectious Disease Research Institute. A single shark could yield up to 300 grams of squalene, enough for about 30,000 doses of vaccine adjuvant.

The oil in a shark's liver helps regulate its buoyancy in the water. Deep-sea sharks, which have higher concentrations of oil in their liver, are sought by fishermen,as are large sharks in more shallow waters.

Shark Allies lists more than 50 species targeted for their livers. Though most are relatively obscure creatures of the deep ocean, others are more well-known, such as whale sharks, great white sharks and basking sharks all of which are considered vulnerable or endangered by the International Union for Conservation of Nature.

Before the pandemic,about 3 million sharks a yearwereharvested for their livers. In a worst-case scenario, Shark Allies estimates 500,000 more sharks will be needed to meet COVID-19 demand.

That number is based on an assumption ofevery person in the world getting two doses of the vaccine made with a shark-based squalene adjuvant.Most candidate vaccines listed by the World Health Organization don't contain that type of immunity-boosting agent,sothe actual number of sharks needed forCOVID-19 vaccines is likely to be far lower.

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GSKis one of the few companies manufacturingan adjuvant with shark-based squalene to support multiple COVID-19 vaccine candidates. In a statement to USA TODAY, the company said research into squalene alternatives is ongoing, but they won't be anoption within the time frame of the pandemic.

The amount of squalene that will be needed to manufacture the intended 1 billion doses of its adjuvant system represents a very small proportion of the animal-derived squalene used worldwide the vast majority of squalene produced is used by other industries including the cosmetic industry, GSK said in the statement.

According to a study in 2012 by BLOOM, a nonprofit group that works to preservemarine life, about 90% of the worlds shark liver oil production feeds the needs of the cosmetics industry, which uses squalene or its hydrogenated form, squalane for its anti-inflammatory properties that reduceskin redness and swelling.

Pointing to someone worse doesnt really relieve your burden of doing the right thing, Shark Allies' Brendl said. The numbers are a little bit out of proportion, but we should change the thing we can change especially when its in our control.

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

More cosmetic companies are switching from shark-based to plant-based squalene. California-based biotechnology company Amyris created aplant-based squalene by fermenting sugarcanein Brazil.

Amyris CEO John Melo said the company could create the worlds supply for squalene in a matter of months at half the cost of harvesting shark livers.

"We can do that all day long, he said. We can do a billion vaccines this month and the next month. We can do that on demand.

The company developed a method by which it extracts a small amount of squalene from low-yield sources such as sugar cane and uses a chemical method to develop a semi-syntheticsqualene that is amplified,according to Casper, who disclosed that the Infectious Disease Research Institute is working with Amyris for its "promising alternative."

Amyris has a long history of making squalane for cosmetics but has only recently begun producing squalene for pharmaceuticals. Itsresearch suggests plant-based squalene performs at the same levelas that derived from sharks.

Everybody in the world deserves to have access to a clean and sustainable vaccine without killing one shark, Melo said.

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Though this semi-synthetic alternative exists, Casper said there's no other natural resource that meets thedemand for a COVID-19 vaccine becauseextracting squalene from a plant source can be "extremely limiting."

Astudy in 2014 in BioMed Research International foundan entire olive tree would yield 16 grams of squalene, about 5% of the yield of a shark, enough for about 1,600 doses of vaccine. Olives are the most plentiful plant source for squalene.

"We are in crisis because we cannot source enoughsqualenefrom the only viable natural source (sharks), but with innovative methods, we can develop semi- or fully synthetic alternatives," Casper said.

GSK said in its statement its committed to exploring the potential for alternative sources of its raw materials when possible, including non-animal-derived sources of squalene foruse in adjuvants.

Brendl is aware it may be too late to stop using shark-based adjuvants for the immediateCOVID-19 vaccine pushbut hopes pharmaceutical companies can make the change by the second orthird generations of the vaccine.

We are not trying to stop anything its just something that we should all in our conscious calculate and try to do better, she said. We can do both: We can take care of sharks and make this vaccine.

Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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Sharks are killed to make effective vaccines. More may die as scientists develop one for COVID-19, conservationists warn - USA TODAY

WASHINGTON - China said on Friday that it had joined a global COVID-19 vaccine distribution plan backed by the World Health Organization, becoming the biggest economy to date to pledge support to distribute the shots fairly.

Meanwhile, the country is holding separate talks with the WHO to have its COVID-19 vaccines assessed, a step toward making them available for international use.

Public health experts welcome the Chinese move, yet caution potential safety concerns.

They are calling on China to publish all its clinical trial data to ensure transparency and gain public trust, saying rushing out a vaccine without adequate efficacy and safety testing is a recipe for disaster.

Clinical trial data

Socorro Escalate, WHO's coordinator for essential medicines and health technologies in the Western Pacific region, indicated this week that China had held preliminary discussions with the organization to have its vaccines included in a list for emergency use.

Beijing currently has at least four experimental vaccines in the final stage of clinical trials. The country has been giving hundreds of thousands of essential workers considered at high risk these experimental vaccines before the conclusion of phase III trials.

Dr. Amesh Adalja, a senior scholar at Johns Hopkins Center for Health Security, told VOA that its important for the WHO to evaluate the Chinese vaccines, yet also called on China to publish its data to ensure transparency.

It is also important that we see the data from the clinical trials and the vaccinations that are already taking place. The world is going to need a lot of vaccines, and if China has developed a safe and effective vaccine, its a good thing. We just need to see the data, he said.

One of the vaccines currently in the final stage of a clinical trial is Ad5-nCoV. Produced by Chinese pharmaceutical company CanSino Biologics, the vaccine has been tested among Chinese military members. Beijing said it had obtained data supporting the vaccines safety and effectiveness. But since China hasnt published that data, international infectious disease experts cannot verify its claim.

This is why it is essential that the Chinese companies release their trial data as well as the data from their experience vaccinating people in the military so that we can all understand how safe and efficacious this vaccine may be, Adalja told VOA.

Dr. Laura Kahn, a scholar at Princeton Universitys Program on Science and Global Security, agrees.

Rushing out a vaccine without adequate efficacy and safety testing is a recipe for disaster, she told VOA, The public must trust a vaccine in order to be willing to get themselves or their loved ones vaccinated, she said.

When scientists raced to develop a polio vaccine in the 1950s before adequate testing, the result was some 40,000 inoculated children contracting the disease from the vaccine, according to Kahn.

"In an era of public mistrust, a vaccine rush job is not the way to go. For the time being, until a vaccine is fully tested, wearing a mask is the way to go," she continued.

Joining COVAX

On Friday, China joins some 168 countries that have already announced their participation in COVAX, including 76 wealthy, self-financing ones. Neither the United States nor Russia has joined the program.

Yet Beijing did not give details on the level of support it will provide to the initiative co-led by the GAVI vaccines alliance, the WHO, and the Coalition for Epidemic Preparedness Innovations (CEPI).

The COVAX initiative aims to deliver at least two billion doses of vaccines by the end of 2021. It is designed to discourage national governments from hoarding COVID-19 vaccines and focusing on first vaccinating the most high-risk people in every country.

Chinese foreign ministry spokeswoman Hua Chunying said in a statement Friday that China has ample Covid-19 vaccine manufacturing capabilities and will prioritize supplying developing countries when vaccines are ready.

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Public Health Experts Urge Caution on Chinas COVID-19 Vaccines - Voice of America

NEW BRUNSWICK, N.J. (AP) A late-stage study of Johnson & Johnsons COVID-19 vaccine candidate has been paused while the company investigates whether a study participants unexplained illness is related to the shot.

The company said in a statement Monday evening that illnesses, accidents and other so-called adverse events are an expected part of any clinical study, especially large studies, but that its physicians and a safety monitoring panel would try to determine what might have caused the illness.

The pause is at least the second such hold to occur among several vaccines that have reached large-scale final tests in the U.S.

The company declined to reveal any more details about the illness, citing the participants privacy.

Temporary stoppages of large medical studies are relatively common. Few are made public in typical drug trials, but the work to make a coronavirus vaccine has raised the stakes on these kinds of complications.

Companies are required to investigate any serious or unexpected reaction that occurs during drug testing. Given that such tests are done on tens of thousands of people, some medical problems are a coincidence. In fact, one of the first steps the company said it will take is to determine if the person received the vaccine or a placebo.

The halt was first reported by the health news site STAT.

Final-stage testing of a vaccine made by AstraZeneca and Oxford University remains on hold in the U.S. as officials examine whether an illness in its trial poses a safety risk. That trial was stopped when a woman developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company has said. That companys testing has restarted elsewhere.

Johnson & Johnson was aiming to enroll 60,000 volunteers to prove if its single-dose approach is safe and protects against the coronavirus. Other vaccine candidates in the U.S. require two shots.

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2nd COVID-19 vaccine trial paused over unexplained illness - Associated Press

Markets expect any COVID-19 vaccine approved this year to only be 50% to 60% effective, asset manager Balyasny says | Markets  Business Insider

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Markets expect any COVID-19 vaccine approved this year to only be 50% to 60% effective, asset manager Balyasny says | Markets - Business Insider

It takes a lot of people to develop a COVID-19 vaccine. Volunteers may be one of the most important. Wochit

Recent pauses to two large-scale COVID-19 vaccine trials and a treatment study should reassure peoplenot frighten themvaccine experts said, though it is a reminder of the messiness of science.

This is an indication that the system is working as it was designed to work to protect human subjects in clinical trials, Lawrence Gostin, a public health and legal expert at Georgetown and Johns Hopkins universities, said Tuesday. It demonstrates that the ethical guard rails on vaccine trials are working.

Its not unusual for late-stage trials of drugs and vaccines to be stopped briefly to examine safety concerns, he and others said.

The discovery of an adverse event and a pause in the clinical trial is actually reassuring, said Dr. Bali Pulendran, a professor of immunology and vaccine design at Stanford University.

Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time. USA TODAY

Lets say they got to the end of the clinical trial and there had not been one single report of any adverse event in the tens of thousands of people involved in the trial. That, he said, would worry me. That would be extraordinarily unusual.

Eli Lilly announced Tuesday it was pausing a trial of an experimental drug similar to one President Donald Trump recently claimed cured him of COVID-19. On Monday, Johnson & Johnson halted a large-scale trial of a candidate COVID-19 vaccine. And, in September, British regulators put a hold on another trial of a candidate vaccine by AstraZeneca. They lifted the hold a week later, but it has continued in the American arm of the study.

These occurrences should serve as a reminder that scientific research can be unpredictable, disappointing and time-consuming, specialists said.

After fourdecades in vaccines, I expect the unexpected, said Dr. Gregory Poland, director of the Mayo Vaccine Research Group and editor-in-chief of the journal Vaccine. The nature of vaccine development is there are always surprises and the unexpected. Everybodys looking for them, but time has to pass before you actually know.

According to a new poll from Informa Pharma Intelligence, a business intelligence provider, and research firm YouGov, 35% of Americans dont trust how quickly the COVID-19 vaccine clinical trials are moving and 23% dont think pharmaceutical companies have consumers' best interests in mind.

The public may have unrealistic expectationsof avaccine that's "100% effective and 150% safe," said Alan Barrett, director of the Sealy Institute for Vaccine Sciences at The University of Texas Medical Branch at Galveston.

USA TODAY Editorial Board: Don't inject politics into vaccine policy

COVID-19 vaccine trial on Aug. 5, 2020, in Detroit.(Photo: Henry Ford Health System/AFP via Getty Images)

But he thinks the companies have shown an impressive attention to safety, including the trial pauses. We cant afford to have a mistake, Barrett said. The public has to have confidence that any vaccine given to them is going to be safe and effective.

Only about 31% of all vaccine candidates make it all the way from Phase 1 clinical trials to market, according to a study published last year.

There are 49 COVID-19 candidate vaccines in clinical trials around the world, with ninein large, late-stage studies, Barrett said. Only three people out of the roughly 300,000 volunteers in all those trials have been known to have suffered serious side effects. Its not a big number, he said.

The key challenge with vaccines, compared with treatments: Vaccines are given to people who are healthy. While a patient dying of cancer may willing to take a medication with lots of side effects, a healthy person shouldnt be subjected to a risky vaccine, said Gostin, a law professorat Georgetown. Thats why we need to be super careful that our vaccines are safe and effective before we deploy them.

Late Monday, Johnson & Johnson announcedit was pausing a trial of its COVID-19 candidate vaccine, JNJ-78436735, while it investigated an unexplained illness in a trial participant. The company as well as an independent Data Safety Monitoring Board will review the participants case before deciding whether to resume the trial.

About half the 30,000 trial participants received a placebo and half the active vaccine. Only the Data Safety Monitoring Board members know which shot the volunteer received. If it was a placebo, the trial is likely to be restarted quickly; if the problem could have been caused by the vaccine, an investigation will take longer.

A similar trial by the pharmaceutical company AstraZeneca was stopped in September after a second trial participant developed an unusual neurological condition.

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In the United Kingdom, where the volunteer lived, regulators examined her case and decided the trial could resume there. But the U.S. Food and Drug Administration has kept the U.S. trial on hold as it investigates her case.

Little has been revealed about her problem, though it is believed to be something called transverse myelitis, a spinal inflammation that can cause temporary paralysis. Both she and the other person who suffered a serious side effect, a woman who had a flare-up of previously undiagnosed multiple sclerosis, have apparently recovered.

(Photo: Getty Images)

If it turns out that the adverse event in the Johnson & Johnson trial was also some type of nerve issue there is a theoretical, but by no means proven, reason it could be linked to the way the vaccine delivers its immunological payload.

There are theoretical reasons it could be, said Dr. Otto Yang, a professor of medicine and associate chief of infectious diseases at UCLA's David Geffen School of Medicine.

Both the Johnson & Johnson and AstraZeneca candidate vaccines use a platform based on a harmless human virus called an adenovirus. The ones they use are uncommon in nature so most people have not developed immunity to them.

A very tiny number of people who are naturally sickened with adenovirus develop transverse myelitis, which is a neurological disorder of the spine that can cause paralysis.

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Nobody knows why it happens, but it appears to be some type of immune response, perhaps the immune system is reacting to the virus and thats causing a cross-reaction, said Yang.

He cautioned that the possibility of a link is extremely theoretical and there is no data to support it at this time but said it certainly warrants a pause while the companies investigate.

Transverse myelitis does happen very rarely all by itself. So if its a 1 in 100,000 event and you see it in one person, then OK. If you see it in two people, then it starts to be suspicious.

Barrett, of the University of Texas, said he doesnt think virus delivery systemscan explain the recent problems. Theres no information to suggest they have problems, he said.

Eli Lilly released a brief statement Tuesday explaining the pause in their trial of a monoclonal antibody, which mimics the natural immune response to the virus.

Safety is of the utmost importance to Lilly, according to the statement, released by company spokeswoman Molly McCully. Lilly is supportive of the decision by the independent D.S.M.B. to cautiously ensure the safety of the patients participating in this study.

Trump last week touted the benefits of the experimental monoclonal antibody he was given a day after his diagnosis with COVID-19. That drug is made by Regeneron, a Tarrytown, New York, company.

The Lilly antibody trial, led by the National Institutes of Health, was to have enrolled about 300 volunteers with mild to moderate COVID-19 who have been sick for fewer than 13 days. Half the participants would receive the antibody via infusion and half a saline infusion. Plans are to expand the trial to another 700 participants,including more severely ill patients if the antibody performs well.

The antibody, called LY-CoV555 or bamlanivimab, was isolated from the blood of a recovered COVID-19 patient.

On Wednesday, Lilly released a second statement, saying that only the Data Safety Monitoring Board, not the company, has reviewed the data so far. This trial, called ACTIV-3, is different from others in the company's portfolio, because patients are sicker and are receiving the highest dose of the drug. The remaining trials ofbamlanivimab continue.

"Individuals in the ACTIV-3 study have been infected with the virus for a longer period of time and may have more severe symptoms than patients studied in other bamlanivimab trials," according to the statement. "Hospitalized patients receive different treatments for COVID-19 than earlier stage patients, including treatment with the antiviral medicine remdesivir."

Gostin, who also directs the ONeill Institute for National and Global Health Law at Georgetown, said hes troubled by this second hold.

The two medical interventions that are most likely to dig our way out of COVID are vaccines and monoclonal antibodies, he said. It shows us that science is miraculous, but its not foolproof and it doesnt always win over Mother Nature.

In the end, said Gostin, we just have to "be patient. Let science take its course.

Contact Elizabeth Weise at eweise@usatoday.com and Karen Weintraub at kweintraub@usatoday.com

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input

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Eli Lilly and Johnson & Johnson have paused COVID-19 vaccine trials. Why experts say that's reassuring, not frightening. - USA TODAY