Category: Covid-19 Vaccine

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

Top vaccine makers predict a vaccine or vaccines may be available as early as the beginning of 2021and at least twopledged doses will be free or low-cost for all Americans.

Speaking before a House subcommittee Tuesday, executives from AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer said their goal is to have effective vaccines available as soon as possible while following all safety and regulatory guidelines.

None of the pharmaceutical executives would commit to having a vaccine ready for the general public before early 2021, despite repeated questioning by House members.

The United States has so far invested nearly $2.3 billion in the effort to find a vaccine to stop SARS-CoV-2, the virus that causes COVID-19, which has killed morethan 140,000 Americans.

Safety emerged as a key concern among lawmakers, with several pressing executives on whether the unprecedented speed of vaccine development or potentially laxgovernment regulations would put the public at risk. All the panelists said safety would not be compromised.

The Food and Drug Administration released extensive guidance covering what would be necessary for a vaccine to be approved on June 30. One of the requirements was that any vaccine be at least 50% effective at preventing COVID-19 infections.

None of AstraZenecas interactions with regulators have indicated there has been any lowering standards, said Executive Vice President MenelasPangalos.

Dr. Julie Gerberding, executive vice president and chief patient officer for Merck, said the company wasrelieved the FDA insisted on applying the same safety restrictions it applies to all vaccines.

Dr. Macaya Douoguih head of clinical development and medical affairs for Johnson and Johnson,offered hypothetically that ifthe FDA guidance were to be changed to require only 10% effectiveness, Johnson & Johnsonwould not release its vaccine.

We would not feel comfortable bringing forth a product that was not efficacious according to our protocol, she said.

Pricing was another questionraised by several House members.

AstraZeneca'sPangalos said the company would be selling to the government at cost, as didJohnson & Johnson'sDouoguih.

The other three companies said they would not.

"We will not sell it at cost, no ma'am," saidModernapresident Dr. Stephen Hoge.

Merck'sGerberding said:"No, we will not be selling vaccine at cost."

Pfizer's chief business officer John Young would not commit to providing vaccine at cost, but said,"We recognize that these are extraordinary times and our pricing will reflect that during the pandemic."

Company leaders also provided updates on their ongoing vaccine efforts:

AstraZeneca will make two billion doses of its vaccine on a non-profit basis, Pangalos told lawmakers.The company, which is creating a vaccine in conjunction with the United Kingdom'sUniversity of Oxford, said Monday it hopes to have a vaccine available by early next year.

The company'svaccine candidate is now in Phase 2clinical trials based on data from pre-clinical studies and being tested onover 1,000 volunteers.

"We are rapidly progressing these clinical programs with the hope that results from our late-stage trials, which are currently planned to involve close to 50,000 volunteers collectively, will be available this fall,"Pangalos said.

The British-Swedish company has entered into agreements with the U.S. and several other countries and organizations to supply vaccine.

The United Statespaid $1.2 billion for access to 300 million doses of the candidate vaccine through Operation Warp Speed, a White House task force focused on bringing therapies and vaccines for coronavirus to market as soon as safely possible.

A paper published Monday gavehope to the overall success of possible vaccines. The results showed theOxford candidate vaccine, AZD-1222, led to strong immune responses for nearly two months in a trial that continues to track more than 1,000 healthy adults.

Pangalos saidhis company plans to supplyapproximately two billion doses globally to provide "broad and equitable access." The company is building parallel supply chains around the world to produce those doses, he said.

More: UKs Oxford University coronavirus vaccine candidate is safe and effective with few side effects, early trial results show

More: A COVID-19 vaccine at what price? Should all Americans be able to get a shot for free?

Johnson & Johnson will charge one price globally for its vaccine, regardless of country or income tier, saidDouoguih.

It plans to manufacture at least 400,000 doses of its candidate vaccine in the United States, she said.

The company is committed to making an affordable COVID-19 vaccine available on a "not-for-profit basis for emergency pandemic use," she said. It will pursue external validation for calculating the price point and will make an external audit or certification available.

The company has received approximately $500million from Operation Warp Speed for its work.

Johnson & Johnson plans to being testing its vaccine candidate in humans late this month in the United States and Belgium. If preliminary results are positive, it will launcha global Phase 3 clinical trial in September.

Phase 3 trials are the final and largest testing stage for vaccinesonce they have become established, don'tcause immediate adverse effects and provoke an immune response. COVID-19 Phase 3 trials will involve 30,000 patients for each vaccine candidate and take many months.

U.S. pharmaceutical company Merck is pursuing two possible vaccine candidates. It is focused on its long track record developing vaccines and the need for safety, and wasopen-minded about the possibility that a breakthrough is not a given.

"If approaches developed by others ultimately are proven superior to those being pursued by Merck, we will work to support those efforts for the benefit of global health during the pandemic," saidGerberding.

Merck holds the record for creating the fastest vaccine ever brought to market, a mumps vaccine in 1967 that took four years from start to finish. But the company has repeatedly emphasized safety over speed in its COVID-19 work.

Speed is important, but we will not compromise scientific efficacy, quality, and above all, safety, despite the sense of urgency we all feel, said Gerberding intestimony provided to the committee.

The company'sCEO, Kenneth Fraizer, said on June 30a vaccine can't be rushed and rigorous science is necessary.

"When people tell the public that there's going to be a vaccine by the end of 2020, for example, I think they do a grave disservice to the public," he said during an interview with the Harvard Business School.

Merck has received $38 million for vaccine research from the U.S. Biomedical Advanced Research and Development Authority, BARDA.

Moderna has made agreements with a Swiss-based vaccine manufacturer with sites in the United States and around the world, which will allow it to reach an annual manufacturing capacity of more than 500 million doses, said company president Dr. Stephen Hoge.

Its candidate vaccine research has been partially facilitated by $536 million from Operation Warp Speed.

Moderna, headquartered in Massachusetts, hopes to beginPhase 3 clinical trials of its vaccine candidate this month,Hogesaid.

Phase 1 resultswere presented last week. The vaccineappears to be safe and to trigger an immune response. Whether the immune response is enough to protect someone from thecoronavirusthat causes COVID-19 remains unclear, according to several experts who reviewed the results.

The company has already enrolled 600 volunteers in its Phase 2 studies, Hoge said.

Alone among the five companies testifingTuesday, Pfizer has not taken any money from the U.S. government as it works on four different vaccine candidates for COVID-19.

"We are uniquely positioned with the scientific expertise and experience, manufacturing scale and financial resources to have the potential to deliver a potential vaccine without funding from the federal government," John Young, Pfizer's chief business officer, said in a prepared statement.

He anticipated the company will invest about $1 billion in its vaccine development efforts during 2020.

Pfizer is partnering with a German biotech companyBioNTech to work on a COVID-19 vaccine. It is currently running early state clinical trials in the U.S. and the European Union.

Last week it announced two of its four vaccine candidates had received fast-track designation from the FDA. It hopes to begin Phase 2 testing later this month.

The company believes it could be submitting an application in to the FDA as early as October, Young said.

If theclinical trials progress well, the companyhopes to manufacture up to 100 million doses by the end of 2020, and potentially more than 1.3 billion doses in 2021 globally, Youngsaid.

"I have great confidence that our industry can prevail in the ultimate outcome of our battle against COVID-19 and that science will win," he said.

Contributing: Karen Weintraub

(Photo: Getty Images)

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Top COVID-19 vaccine makers say safe, effective and low-cost candidates possible by early 2021 - USA TODAY

Another COVID-19 vaccine candidate recently entered the races. The difference this one is a live attenuated (weakened) virus expressing the coronaviruss signature spike protein on its surface. And its delivered nasally, not a shot.

COVID-19 vaccine development will be more of a marathon than a sprint, Martin Moore, Ph.D., co-founder and CEO of Meissa Vaccines, told BioSpace. A live attenuated vaccine may not be first-in-class, but their historically high efficacy could make it the best-in-class.

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Moore spoke with BioSpace about live attenuated vaccines, interim data from their RSV vaccine candidate, and how they are building on their RSV vaccine platform to create a COVID-19 vaccine.

Live attenuated vaccines (LAVs)

Think about it what is the best way to generate an effective vaccine against a virus? Mimic natural infection as close as possible by giving someone a form of the virus that cant make them sick.

This is just what live attenuated vaccines (LAVs) do. LAVs contain a weakened form of a virus that is given to someone the same way that natural infection occurs, such as via a nasal spray (intranasally) for the flu LAV. This provokes all aspects of the immune system: innate local (mucosal), cell-based, and systemic antibody (humoral) responses.

Once inside the body, the weakened virus can replicate at a low level for a few days, but it is easily cleared by the immune system. After just one or two doses, the weakened virus produces strong, long-lasting immune responses that are almost as good as the full-strength virus that causes sickness.

By mimicking infection, LAVs generally provide more robust immune responses compared to injected non-living vaccines that typically only induce the antibody-based immune response. Thats why you usually have to get booster shots of injected vaccines.

This concept is hardly new. In fact, LAVs are already available against multiple viruses, including measles, mumps, rubella (as the combined MMR vaccine); rotavirus; and chickenpox.

The oral polio vaccine is a great example of a live attenuated vaccine, Moore said. Its low cost, able to be given widespread, and easy to administer with no needles or adjuvants needed. From a manufacturing standpoint, its also inexpensive and pretty easy to produce.

Advantages and limitations of live attenuated vaccines (LAVs)

Advantages

Limitations

1-2 doses

Cant be given to immunocompromised people

Lower cost

Need to be refrigerated

Administered through the same route as natural infection (intranasal, oral, etc.)

Genetic stability of virus is important for safety

No needles or adjuvants needed

Strict safety levels to adhere to during development

Induces both cellular and humoral (antibody) immune responses

Need to balance attenuation with potency/immunogenicity

As you can imagine, there is an inherent risk in using the actual (albeit weakened) virus for a vaccine. Viruses constantly mutate, so the weakened virus used in the vaccine has a chance of regaining its ability to be infectious and cause disease.

Creating a LAV is a balancing act the virus must be weakened enough to significantly reduce the risk of it mutating to become infectious, but still close enough to the full-strength virus to create a similar immune response.

The trick is balancing attenuation with immunogenicity, Moore commented.

Moore explained that if a virus is attenuated based on one or two gene mutations, the virus could revert to being infectious in the vaccine recipient and they can shed live virus, spreading it to others. This is the worst-case scenario and why there are such strict safety standards for vaccines, especially LAVs.

Safety is critical, there are no cutting corners with safety, explained Moore. Coronaviruses, in particular, are prone to genetic recombination, so using a live attenuated coronavirus in a vaccine would run the risk of becoming infectious again. Weve mitigated this risk by using RSV, which is more genetically stable, as a backbone.

Building from the foundation of another respiratory vaccine

The backbone of Meissas COVID-19 vaccine comes from another vaccine in their pipeline their respiratory syncytial virus (RSV) vaccine candidate. RSV, a common respiratory virus, usually causes mild cold symptoms; however, infants and the elderly may be hit particularly hard. RSV is infamous for being the culprit behind serious illness and pneumonia in infants less than 1 year old.

To create their intranasal RSV vaccine candidate (called MV-012-968), Meissa genetically engineered RSV to be weakened and safe, yet still potent, by using codon deoptimization.

Codon deopti-what?

Quick genetics review: a codon is a group of three bases in DNA or RNA that encodes a certain amino acid (the building block of proteins). Codons are the genetic code that translates genes into proteins. (Think of bases as the letters of the alphabet, codons as the words, and each gene as a sentence.) There are 64 different codons, but only 20 amino acids that they code for. Almost all amino acids are encoded by multiple codons; some codons for a particular amino acid are used more commonly than the others.

Codon deoptimization is changing the more common codons into the less common codons for the same amino acid throughout a gene. This introduces many silent mutations, changes in the genetic code that do not alter the resulting proteins being made.

This approach to viral genes has been called death by thousands of cuts, Moore explained. By using rare codons, codon deoptimization can change the expression efficiency of proteins.

The rare codons do not have as many amino acid transporters, called transfer RNA (tRNA), so they can slow down the translation process of turning genes into proteins. The slower the gene is translated, the fewer corresponding proteins is made (the lower the protein expression).

Using codon deoptimization, weve downregulated three RSV genes involved in the viruss ability to inhibit the human immune response to create our attenuated RSV, said Moore. This gives us optimized manufacturability, attenuation, and immunogenicity.

By taking away the viruss ability to inhibit immune pathways, Meissa is engineering attenuated vaccine strains that produce a solid immune response. This is key for viruses that dont provide strong immunity to begin with, like RSV or coronavirus.

Their RSV vaccine candidate, which received Fast Track Designation from the FDA in January, is currently in Phase I trials in healthy adults and young children. Previously, it was shown to produce a robust immune response in rats despite being highly weakened. The company recently provided an interim update announcing that initial clinical data showed the vaccine generate an immune response in healthy adults.

There are three main takeaways from the clinical data: the RSV in the vaccine was heavily weakened (as indicated by the lack of viral shedding from the nose); the vaccine prompted an RSV-specific immune reaction in the nose; and the vaccine was reported to be safe and well-tolerated up to 56 days.

All adults in this study have pre-existing titers of serum neutralizing antibodies systemically, Moore explained. All adults have already been infected with RSV previously. Ideally, we want to give our RSV vaccine to RSV seronegative babies so it will produce nasal and humoral immune responses.

Creating the COVID-19 vaccine candidate

Based off the interim RSV vaccine data, researchers at Meissa thought Could we modify our weakened RSV to create a COVID-19 vaccine?

COVID-19 patients dont seem to have a robust neutralizing antibody response, with lower titers that decrease rapidly over short periods of time, said Moore. This is bad news for developing a live attenuated coronavirus-based vaccine if you weaken the coronavirus further, how are you going to get the immunogenicity needed for a robust immune response?

You would overcome that issue by deeply understanding the biology of the coronavirus, Moore continued. Unfortunately, coronaviruses are some of the largest RNA viruses on the planet (genetically speaking), making them extraordinarily complex. Fortunately, RSV is not nearly as complex (about half of the size of coronaviruses, genetically), making it much easier to work with.

Using an RSV backbone for the COVID-19 vaccine also makes a lot of sense given the similarities between the two viruses: they are both respiratory viruses and inhibit the innate immune response during infection.

To create their COVID-19 vaccine, Meissa removed the surface proteins of their weakened RSV and replaced them with the coronavirus spike protein. The RSV-coronavirus hybrid virus was optimized to express the spike protein. This chimeric virus has the best of both worlds the established, weakened RSV construct and high expression of the coronavirus spike protein. Because this vaccine is RSV-based, they completely avoided the slippery genetic slope of using a weakened coronavirus.

Meissa plans to submit an IND later this year and anticipates a Phase I trial of their COVID-19 LAV to begin at the end of 2020. Moore said that the company is working on scaling up manufacturing now so that the COVID-19 vaccine could be in a large pivotal study in 2021.

Other COVID-19 vaccines in development

We all know that the COVID-19 vaccine development pipeline is becoming quite the rapid race. As of July 8, 2020, there were 165 vaccines in development, according to Bio. You can follow development of the most famous vaccine candidates using the New York Times Coronavirus Vaccine Tracker tool, which is periodically updated with new information.

Out of all the other COVID-19 vaccines being developed, only a few use live attenuated viruses. There arent enough LAV candidates in the broader pipeline, which is dominated by nonreplicating vaccines, commented Moore.

In late January, Yuen Kwok-Yung, Chair of Infectious Diseases at the University of Hong Kong, said his lab modified an intranasal flu vaccine they had previously developed so that the influenza virus also expressed coronavirus surface antigens. (There hasnt seemed to be any updates about that vaccines progress.)

Another company, Codagenix, Inc., is using codon deoptimization (like Meissa) to create vaccines against respiratory diseases like RSV and influenza. Theyve also jumped into the COVID-19 vaccine race with their candidate, called CDX-CoV. They successfully created the vaccine in mid-June and it is still in preclinical studies.

Only 5-7 percent of Americans have been infected and natural immunity doesnt seem to be that robust, so we could be in for quite a slog, Moore concluded.

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Another COVID-19 Vaccine Joins the Race This Time, it's a Live, Weakened Virus - BioSpace

Russia could be only a few weeks away from starting mass production of a vaccine for Covid-19, but the unorthodox approach adopted to speed up the process is likely to reduce the chances of the Russian vaccine gaining worldwide adoption.

The first domestic vaccine against the novel coronavirus infection is ready, stated Russian Deputy Minister of Defense Ruslan Tsalikov in an interview with Russian newspaper Argumenty i Fakty on Tuesday.

The statement came one day after a last group of volunteers was discharged from hospitals showing positive results in Phase I trials of the vaccine. All of them, according to Russian authorities, had developed immunity to Covid-19.

Russias research into the vaccine has been led by the state-run Gamaleya National Research Centre for Epidemiology and Microbiology and the Main Military Clinical Burdenko Hospital, Tsalikov said.

The research was supported by the Ministry of Defense, which has significant experience with vaccine development, having previously made major contributions to an ebola vaccine, Tsalikov said.

The research was funded by Russias sovereign wealth fund, the Russian Direct Investment Fund.Fund head Kirill Dmitriev told the media on July 16 that the vaccine would be ready to enter mass production by the end of August.

According to Dmitriev, Russia could produce 30 million doses for domestic usage in 2020 and 170 million for abroad, with several countries already expressing interest in producing it.

The Russian Health Ministry, however, has been more cautious in assessing the progress, pointing out that the vaccine needed to complete two more trial phases.

An intense international race is underway to find a vaccine for the novel coronavirus, which so far has killed more than 600,000 people around the world. More than 150 vaccines are now being developed, with Chinas Sinopharm and the UKs Oxford University and AstroZeneca among the leaders in the research.

With Russia having 782,040 Covid-19 cases and 12,561 deaths, Moscow has now emerged as a front runner as it charges through clinical trials.

The phase one tests which involved military personnel were completed last week and included tests of both powder and liquid vaccines. The second phase trials are due to be completed within the next two weeks.

The last phase of the trials, due to start on August 3, will be conducted on thousands of people in not only Russia, but also in Saudi Arabia and the United Arab Emirates.

But according to Anton Gopka, head at the health-care investment firm ATEM Capital, such speedy advancement in vaccine development has only been possible by sacrificing the quality of the testing.

There wont be enough data to prove that the vaccine is completely safe. Normally you need over a year to guarantee that level of safety, he told Asia Times.

Separately, senior South Korean officials told reporters last week, citing safety concerns, that they do not anticipate the rollout of a vaccine to be feasible this year.

Another question hanging over the Russian effort is why the country took unorthodox steps in testing. Not only has it used military personnel instead of regular volunteers, scientists have also been self-testing.

As revealed by Alexander Gintsburg, the head of the Gamaleya Institute, in an interview on state channel Rossiya 1, scientists have been testing the experimental vaccine on themselves since May, before any authorization was given by the Ministry of Health. Gintsburg admitted publicly that he tested the vaccine on himself and his family.

Scientists self-testing triggered widespread condemnation, even from the domestic clinical research association, which defined it as a crude violation of the foundations of clinical research conduct, Russian legislation and international norms.

Even more criticism arose after anonymous sources cited by Bloomberg in an investigative report claimed that members of the Russian elite have been getting shots of the experimental vaccine since April.

Among those who took the vaccine were government officials and top managers at aluminum giant United Co Rusal.

The Bloomberg story raised many questions within Russia.

Asked whether President Vladimir Putin had been among those who took the vaccine, his spokesperson Dmitry Peskov replied that it probably wouldnt be a good idea to use an uncertified vaccine on the head of state.

Commenting on the Bloomberg allegations, Gintsburg said he was not aware that members of the elite had access to the vaccine. Meanwhile, the Ministry of Health denied that the vaccine was tested on anyone apart from volunteers officially enlisted for trials.

And Moscows efforts to win the upper hand in the race for the vaccine may have gone even further than Gintsburgs statements and the Bloomberg story suggest.

According to American, British and Canadian authorities, the Kremlin has been deploying hackers to steal information on vaccines from Western research centers.

Western cybersecurity agencies claim the Russian hacker group known as Cozy Bears was behind the attack. The group, which is considered to have ties to Russian secret services, was involved in hacking the Democratic Partys database during the 2016 US Elections.

The allegations, made at the highest levels, have generated a major diplomatic row. It is completely unacceptable that the Russian Intelligence Services are targeting those working to combat the coronavirus pandemic, said UK Foreign Secretary Dominic Raab.

Russian officials denied any involvement in the hacks.

Meanwhile, some observers are considering the rationale behind Moscows headlong rush in vaccine development.

As pointed out by Gopka, even if Russia is the first to release its vaccine, that would not necessarily bring many benefits to the country if its research protocols are suspect.

At the end of the day, the winner of the race will be the vaccine which will be accepted worldwide, said Gopka.

According to the venture capitalist, given the highly unorthodox methodologies adopted for testing, it is highly unlikely the Russian vaccine will be sold worldwide. These methods cast a shadow on the overall process and on the quality of the research, Gopka said.

Still, at a time when Russia is facing Western economic sanctions and suspicions on multiple fronts, Moscow may not simply want the kudos of winning the vaccine race.

A further motive could be that the Kremlin does not want to end upbeing dependent on an upcoming Western vaccine hence the urgent need for a Plan B.

Russia needs a domestic vaccine as a way to negotiate prices down, suggested Gopka. If the prices of a Western-developed vaccine are too high, they will use a domestic one.

Asia Times Financialis now live. Linking accurate news, insightful analysis and local knowledge with the ATF China Bond 50 Index, the world'sfirst benchmark cross sector Chinese Bond Indices.Read ATFnow.

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Russia aiming to be first to find Covid-19 vaccine - Asia Times

Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial  The Lancet

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Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled...

Dr. Sarah Hasan says last week more than 4,000 people called, texted and emailed with questions.

HOUSTON As the Moderna COVID-19 vaccine enters Phase 3 of testing, two Houston clinics need your help.

"This is what we call medical heroes," said Dr. Sarah Hasan, a recruitment lead with DM Clinical in Tomball.

Thirty thousand people will receive the vaccine in the next phase. Houston is one of 87 locations across the country where the vaccine will be tested. The Texas Center for Drug Development is looking for about 1,000 volunteers to receive the vaccine.

"The interest we're seeing right now is on a whole different level," Hasan said. "Everybody wants to do their part so we can get back to normal."

Last week, Hasan said the clinic had more than 4,000 people call, text and email with questions and to apply.

"One of the most common questions is, 'Am I guinea pig? (And) Is this experimental?'" said Hasan. "Of course it's a totally valid question. This is not a live vaccine, so you cannot contract coronavirus from this vaccine itself."

Hasan said prior phases of testing focus on safety and side effects. This phase will figure out how effective it is.

"If everything works out the way we hope,and we don't get any unpredictable potholes and bumps in the road, we should know as we get into the mid- to late fall, early winter, but probably late fall weather we have candidates that really are safe and effective," said infectious disease expert Dr. Tony Fauci.

If you're 18 and older you're eligible to apply.

"All demographics, all races, it's a broad net we're casting out there," said Hasan.

Only folks with active cancers or autoimmune disorders would not qualify. If you're interested apply at http://www.houstonfightscovid.com.

"You can receive up to $2,000 to participate in this study," said Hasan.

Researchers will call you within 24 hours of applying to go over your medical history and determine if you qualify for the next steps.

"The part in the lab has already been done, but what we need now is the community to come together," said Hasan.

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KHOU has just upgraded its technology. If you were unable to receive KHOU with your antenna in the past, try again on channel 11.11. You may have to rescan your channels for it to work if thats the case, weve got some instructions at KHOU.com/antenna. If you already see KHOU on 11.1, you may now ALSO see it on 11.11 its the exact same programming. Were really excited to be able to bring our KHOU 11 News, CBS shows and sports, Wheel of Fortune, Ellenand Great Day Houston to more homes around the area. If youre still having trouble, please contact us here and well try to get you set up.

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Houstonians can receive up to $2,000 to help with third phase of COVID-19 vaccine testing - KHOU.com

At least two North Texas research facilities will begin widespread trials of the vaccine created by the National Institutes of Health and Moderna next week.

DALLAS, Texas The race to establish a successful COVID-19 vaccine is heating up and North Texans can now play a role.

At least two North Texas research facilities will begin widespread trials of the vaccine created by the U.S. National Institutes of Health and Moderna Inc. next Monday.

A study in the New England Journal of Medicine published results of the first phase of the experimental vaccine trial, which found "the vaccine-induced immune responses in all participants with no trial-limiting safety concerns."

In that study, 45 participants were involved.

Volunteers developed the same levels of neutralizing antibodies in their bloodstream as those who had survived COVID-19.

There have been side effects, however. More than half of the original participants reported flu-like reactions like headache, fatigue, chills, fever, and pain at the injection site. And that early test only included younger adults, which is why more tests are needed for other parts of the population.

A 30,000-person study starting on July 27 will prove if the results can be seen on a larger scale.

Wake Research in Dallas and The Fort Worth office of Benchmark Research will be participating and is now looking for volunteers.

Dr. Denis Tarakjian of Wake Research said the phase I results show that hope is on the horizon.

"They're very, very encouraging," Tarakjian said. "Our job now is to get more patients involved in the study."

Tarakjian is based out of San Diego and is a key researcher for Wake.

He told WFAA that his firm is looking for participants who are over 18 and preferably frontline workers. That includes cops, first responders, medical workers, pharmacists, grocery store employees and transit and airline employees.

"We're looking for participants who are facing a high risk of exposure to COVID-19," Tarakjian said.

Those with underlying medical conditions or over the age of 65 are also a key demographic needed considering the earlier results focused on just younger people.

"We want to have a complete age spectrum of patients," Tarakjian said.

Half of the participants tested will be given a placebo or control for the study.

The others will be given two dosages in 28-day intervals, Tarakjian said.

If you live in Dallas, you can enroll by texting "COVID" to 972-573-9490 or by going to http://www.covidstudies.org.

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Researcher looking for North Texans to participate in breakthrough COVID-19 vaccine trials: 'This is the first big step' - WFAA.com

LUBBOCK, Texas KAMC Weekend Meteorologist Lance Blocker was selected to participate in a COVID-19 vaccine test trial being developed by Moderna and sponsored by the National Institute of Allergy and Infectious Diseases.

Blocker, a Georgia native was among 110 Americans selected for the test trials back in late March. Blocker was given two doses of the MRNA-1273 vaccine and also received a small financial stipend.

I fully trust these folks, said Blocker. These are the smartest people in the world working on this thing.

Blocker said he has had heavy fatigue and mild shortness of breath as side effects.

When I was given the opportunity to participate in this, it was really a no brainer because if theres a risk, they already know about it, said Blocker.

Researchers said the MRNA 1273 vaccine showed promising data with the 110 participants. Because the vaccine produces essential antibodies and is safe for humans, Moderna plans to expand the test trials to 30,000 Americans by the end of summer 2020.

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KAMC meteorologist participating in COVID-19 vaccine test trials - KLBK | KAMC | EverythingLubbock.com

Multiple Indian COVID-19 vaccines set to enter trial stages.

While India is set to begin the trials of its indigenous coronavirus vaccine from this week, a top official from the Indian Medical Association (IMA) has claimed that a vaccine cure for the deadly COVID-19 upon its development and marketing would reach usable stage only after 2020.

"A usable vaccine to cure COVID-19 and bringing the same to good use would go beyond 2020. Developing a vaccine for viral infections is a longer process as firstly, these infections have shorter immunity and secondly, viruses mutate faster, so this makes developers clueless as to which mutation is there in which part of the country," said Dr V K Monga, IMA Board of Hospitals Chairman.

Dr Monga further added that for developing a vaccine there are multiple stages and steps. "Developing a vaccine is not a political decision, it involves a lot of steps and procedures," he said. Explaining the process, he said, "First, we isolate the virus then you develop an antidote to that, followed by animal testing and then on human volunteers. Secondly, you see the efficacy, toxicity and then its longevity as to how long it sustains."

"Since the viral infections have shorter immunity, a vaccine with a longer effect is to be seen; secondly, we have to see that it has no side effect and thirdly, viruses mutate faster and hence, it has to be seen that the vaccine is effective on most of the mutants as we don't know which mutated virus is present in which part of the country," he said.

Speaking about the rise in the recovery rate, Dr Monga said that in this particular disease, approximately 80 per cent of the people are recovering on their own. "These patients will automatically recover. Home isolation is a good thing," he said adding that people using masks and adhering to social distancing norms is also increasing recovery. However, he clarified that plasma therapy, which is being seen as the only solution to COVID-19 in place of the absence of the vaccine, can't minimise the need of a vaccine.

"In the case of COVID-19, only vaccine or immunity can defeat the present disease," he said. Regarding community spread of this virus, he added that community spread of COVID-19 has begun in India and the major causes of this are migration of labourers and discontinuing of contact tracing of COVID-19 patients.

"We have indeed moved into community transmission phase. The government may not acknowledge it but look around how the people are getting infected. There are elderly who have not stepped out of home since months yet they have contracted the infection. There are women who have only gone out to buy vegetables in a week and carried home the COVID-19 infection," he said.

"The authorities are unable to track and trace the contacts of each positive case. Also, it is believed that 80 per cent of the population is asymptomatic and have not tested themselves. A few days ago, Kerala government admitted about community transmission in a few districts despite the state having fewer cases in comparison to Delhi and Maharashtra," he added.

With 38,902 new cases reported in the past 24 hours, India's total coronavirus cases on Sunday reached 10,77,618. With 543 new deaths the death toll stood at 26,816, Health Ministry data said. Karnataka is the new hotspot state nearing 60,000 cases, as Maharashtra remained the worst-hit state, with 3,00,937 cases and 11,596 casualties. It crossed the 3-lakh mark on Saturday with Mumbai reporting over 1 lakh coronavirus cases so far.

It is followed by Tamil Nadu with total 1,65,714 cases and 2,403 deaths. The national capital, on the other hand is projecting an uplifting trend. For 17 of the last 20 days, including 11 in a row now, the number of people recovering from COVID-19 in Delhi has remained higher than newly detected infections -- no other state has come close to such a trend.

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IMA Official Says India's Indigenous COVID-19 Vaccine to Reach Usable Stage Only After 2020 - The Weather Channel

In 2003, he played a key role in aWorld Health Organizationinvestigation that swiftly identified a coronavirus as the cause of SARS. Stohr alsosounded the alarmon the pandemic potential of avian flu, bringing countries and companies to the table to increase production of vaccines in case it began spreading widely in people.

In Covid-19, which has killed almost 600,000 people, the world faces the crisis that the virologist has long feared. Stohr, who left the WHO to join drugmakerNovartis AGin 2007 and retired a couple of years ago, paints a sobering picture. He spoke with Bloomberg by phone, and his remarks have been edited for clarity and readability:

Bloomberg: How do you see the pandemic advancing before a vaccine potentially is available?

Stohr: The epidemiological behavior of this virus will not be that much different from other respiratory diseases. During winter, they come back.

There will be another wave, and it will be very serious. More than 90% of the population is susceptible. If we do not tighten again to a serious lockdown or similar measures, the virus is going to cause a significant outbreak. Winter is coming before the vaccine. There will be an increase in cases, and there will be problems containing it because people seem not very amenable to more constraints in their movement and freedom.

Bloomberg: When do you predict vaccines may arrive?

Stohr: Countries like Germany may have a significant amount of vaccine by the beginning of next year and a rollout that may take four, five, six months for the elderly. The strategy may be different for a country like Brazil, Argentina or Chile, which may never get a single dose of a vaccine and still has to cope.

The world will be divided into two groups, those with vaccines and those with no vaccines.

Bloomberg: How do you see worldwide immunity ramping up as vaccines are introduced and the disease spreads?

Stohr:I would assume that by the middle of next year a significant portion of the world will have antibodies. That will increase gradually over time. Then there will be a third wave, and when that is over, I would think that 80% of the world may have antibodies if lockdowns are not instituted, which I doubt.

Bloomberg: What does that mean for vaccines under development?

Stohr: Were in a big, big quandary. We have to throw all the resources we can afford toward the development of a vaccine. On the other hand, I believe common sense tells us vaccines will not be available for the majority of the world.

There may be, by the end of this year or beginning of next year, a half a billion doses available. The world population is 7.5 billion. Particularly in those countries which have insufficient infrastructure and struggle with their health-care systems and have huge populations, what vaccine are they going to have?

Bloomberg: A number of groups, including the WHO, are focusing on equitable access. Wont that help tackle those concerns?

Stohr: It would be irresponsible not to do anything. Nevertheless, the majority of the world population will not receive a vaccine. The virus will continue to spread, and it could take two to three years before the virus has affected a large majority of the population.

Its not the vaccine thats going to end the pandemic. The virus will end this pandemic by burning every piece of dry wood it will find. The fire will not go out before the last susceptible person has been affected.

Then the question is what role will any vaccine play afterward.

Bloomberg: You seem optimistic researchers will succeed in coming up with vaccines. How do you assess the prospects and potential risks?

Stohr: The coronavirus is not a particularly difficult virus to handle. Even the conventional vaccines could make a difference, and we have different approaches, vector vaccines, mRNA. That is very promising.

In the past, when a vaccine is introduced, you have a gradual increase in its use, in the number of people immunized, and if anything comes up, even very rare events, they will be noticed pretty early. But here, a vaccine will be used in large amounts, possibly hundreds of millions of doses, in a relatively short period of time, six months to a year. So the question is if there is anything possibly lingering in the vaccine that cannot be detected in the large-scale safety testing during the approval process.

It could hit many, many people. If you immunize 500 million, and its only 1 in a million who is affected, you still have a significant number of people who may have safety problems, so that is something that has to be addressed. But one has to balance the concern about the impact of the disease against the concern of the possible impact of the use of the vaccine.

Bloomberg: Youve said countries need to adjust their strategies. What is the best approach governments can take?

Stohr: We have to find a way to open our community in a way that supports our long-term medical goal, which is the least number of casualties over time, knowing that you cannot avoid the spread of infection. There is no other tool available. If youve got a medical problem, you go skiing, you break your leg, your knee ligament is torn, no problem, go to the doctor and get it fixed. We have no fix here.

We have to live with this virus and we have to find a proper way to ensure that when we are through with this we look back and say we did the best to prevent death and disease. But we cannot do the ostrich policy here andhopethat some miracle will happen and the virus will disappear. The perfect strategy isnt available.

Bloomberg: Youve tackled other viruses from SARS to bird flu, are there any lessons from the past that are relevant today?

Stohr: Since 2003 weve been talking about pandemic planning. Some countries developed these plans and used them. I believe those who had a decent pandemic plan were a couple of steps ahead. But there are still countries with no plans. The learning is get your pandemic plan ready.

It may be clear that only those who will have vaccine production on their soil will have access to vaccines during the pandemic. Ihopeits not going to turn out this way, but I fear it will. That hopefully will result in more investment into pandemic preparedness and vaccine preparedness in the coming years, so that the next pandemic will be addressed better than this one.

This story has been published from a wire agency feed without modifications to the text. Only the headline has been changed.

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Most of world to face coronavirus without Covid-19 vaccine, says expert - Livemint

After four months of quarantines, social distancing, and disrupted routines, it's the one question that almost everyone has on their minds: When will a new coronavirus vaccine be ready? The answer, just like every other aspect of this new virus thus far, isn't clear. But creating an effective vaccine is only half the battle, say leading health experts who work with international data and set policies here in the United States, and usually the process takes up to 15 years. Distributors will also have to rush out any new vaccine to all 50 states when the time comes. Plus, there's another big follow-up question to consider: Will everyone actually sign up for a vaccine when it's ready?

A team of journalists at the New York Times are keeping tabs on every single COVID-19 vaccine trial occurring across the globe; per their data, more than 150 vaccines are in development, with nearly 25 of them already in human trials (with new trials popping up every day). COVID-19 patients in Brazil were among the first to be admitted into human trials, and a first human trial has already concluded in Russia, Forbes reports; here in the United States, one high-profile trial being conducted by Moderna is now testing thousands of volunteers this month, according to National Geographic. Eventually, we'll hear about the trials here in the U.S. that are the most promising in the eyes of the government, as Operation Warp Speed a government-backed initiative to invest billions of dollars towards producing a new vaccine was unveiled in May.

So when will we see the first potential vaccine, then? Based on early reports and chatter from the international health community, a team behind a high-profile vaccine trial in the United Kingdom seems to "think they're going to be the first around the track," explains William Schaffner, M.D., the medical director for the National Foundation for Infectious Diseases, where he has been consulting for multiple organizations (including the Centers for Disease Control and Prevention). "It could well be that in late fall, some data may become available but for the most part, [the medical community] anticipates that it won't be rolled out until the early part of next year."

If you're interested in keeping tabs on each individual trial as it progresses, officials at the World Health Organization are updating a landscape document about ongoing vaccine candidates on a current basis. View their progress tracker.

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It's another important question, since it appears that attempts to reopen businesses and resume routines are still leading to upswings in new COVID-19 cases and deaths (Florida, Texas, and California may have accounted for 20% of the world's cases in mid-July alone). The key to understanding why a vaccine is so important requires an understanding of the term herd immunity. "The herd immunity is achieved in populations through both natural methods and built resistance as in someone recovers from the infection as well as artificially induced immunity, as in resistance with the help of a vaccine," explains Bojana Beri-Stoji, MD, PhD, CHES, an ambassador for the United Nations' Society for Public Health Education and director of the master of public health program at Fairleigh Dickinson University. "There has to be 95% of the population that's resistant (either naturally or artificially) to a virus for herd immunity to occur."

Theoretically, herd immunity could naturally become quite high (upwards of 60% of the population) before the vaccine arrives thus reducing the likelihood of transmission in public but experts are trying desperately to avoid this scenario. "We certainly don't want to come to that, because that would require a colossal number of deaths and hospitalizations that would have occurred by the time we achieve that Until we have a viable vaccine, we have to continue social distancing, wearing masks, and all of the other methods we know now," Dr. Schaffner explains.

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After a vaccine is made available to the American public, we may finally start to see our routines return to pre-COVID schedules, and for social distancing guidance to be lifted, Dr. Beri-Stoji adds. "If there was a safe and effective vaccine available, theoretically, that would be the best solution to lift social and business restrictions," she says. "[But] only if at least 80% of the population would be immunized, with another 15% having recovered from COVID-19 or already being naturally resistant."

But therein lies another question: Will most or all Americans sign up for the vaccine? An early poll conducted by the Associated Press-NORC Center for Public Affairs Research found that only 50% of adults who were polled indicated they would get a shot when the time came. "It's not a foregone conclusion that we'll be able to reach out and vaccinate everyone," Dr. Schaffner says. "As much as the vaccine is anticipated by many, others will have to be persuaded to participate Some people are going to wait for a whole lot of others to get vaccinated to make sure it's safe."

When a vaccine is developed, supply will be limited at first and the government will have to decide who gets it first. According to Dr. Schaffner, CDC officials are working on a roll-out plan for the COVID-19 vaccine at the Advisory Committee on Immunization Practices; this group established who was first in line for a swine-flu vaccine back in 2009, for example. "That committee is in the middle of a very elaborate discussion, and they're reaching out to all kinds of professional organizations to get some sort of idea about a prioritization scheme."

Normally, a vaccine isn't actually rolled out geographically; it'll be done by the characteristics of a community, Dr. Schaffner says. "Some [characteristics] are illness rates, but some might be race, because we know that people of color and lower socio-economic standing are more apt to have serious disease," he explains, adding that age and occupations may also come into play. "Healthcare workers ought to be first in line, those who are caring for the very sick, because we need them to be healthy."

While the prioritization scheme isn't established just yet, Dr. Schaffner says there will be a protocol scheme in place, but it may change as the pandemic unfolds. "Sometimes, despite planning, you have vaccine left in the refrigerator because you couldn't get people who were eligible to come in You have to have some flexibility, because obviously it can't be implemented in the same way everywhere around the country simultaneously."

At first, there were many comparisons made between the flu and COVID-19 so naturally, some people are wondering if a COVID vaccine might function like a flu shot. "There's no way to answer this definitely at this time, because there's no indication what type of vaccine is both safe and effective in humans," Dr. Beri-Stoji says. "I think, even if the virus remains unchanged, there will be multiple vaccines available, but not before the fall of 2021."

Clinical trials will determine whether or not we'll need only one vaccine, or if we'll need to have a new shot each year during what will be a doubly tough flu season. Plus, it could be that a vaccine isn't totally preventative just like a flu shot meaning you could still come down with COVID-19 despite a shot. "Whatever the level of protection, how long will it last? Will it last five years, or will everyone have to roll up both sleeves, get a flu shot on one side, and COVID on the other?" Dr. Schaffner muses. "I'm afraid the answer to those questions is, well, we won't know until we know."

As more information about the coronavirus pandemic develops, some of the information in this story may have changed since it was last updated. For the most up-to-date information on COVID-19, please visit the online resources provided by the CDC, WHO, and your local public health department. You can work to better protect yourself from COVID-19 by washing your hands, avoiding contact with sick individuals, and sanitizing your home, among other actions.

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When Will a Coronavirus Vaccine Be Ready? - GoodHousekeeping.com