Category: Covid-19 Vaccine

One of public health's greatest accomplishments was eradicating smallpox back in 1979. To eradicate SARS-CoV-2, the virus that causes COVID-19 illness, we'll need a vaccine that's 70% effectiveand 70% of the population will need to receive it, an FDA vaccine official said Wednesday.

That's a higher bar than the FDA set last week. To pass muster at the agency, a COVID-19 vaccine will need to be at least 50% more effective than placebo, according to new FDA guidelines.

But the agency felt a 50% efficacy requirement was a reasonable place and about comparable to a flu vaccine on a good year, said Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), during a webinar hosted by the Alliance for a Stronger FDA.

And despite R&D moving at record speeds, Marks cautioned that vaccines are still several months away. Itll take weeks to months to get phase 3 trials enrolled, and some regimens will require two injections several weeks apart. Then, investigators will need to follow the trial participants for a few months.

RELATED: FDA official leaves 'Warp Speed' to preserve independent regulatory power: report

Were not going to have one in early fall, he said. Its going to take months.

For an emergency use authorization, the most likely timing would be after a late-stage trial's interim analysis shows safety and efficacy but before the developer can complete its full submission for approval, he added.

In the long run, there may not be one winner in the hunt for a COVID-19 vaccine. One vaccine might work in older adults, while another might perform better in younger people, Marks said.

RELATED: FDA will require 50% efficacy for COVID-19 vaccines. How high is that bar?

That's why the FDA is strongly encouraging companies to enroll a diverse group of trial participants, including racial and ethnic minorities, plus older adults and others, Marks said. The pandemic has disproportionately affected communities of color.

Citing the urgency, the agency is poised to move review of any submissions" as quickly as possible, he added.

On the prospects of a challenge trial, where investigators would infect volunteers with COVID-19 to test a vaccine candidate's ability to protect, Marks didnt completely rule it out. There are ethical concerns because there isnt a ready treatment for the novel coronavirus, but the FDA would consider such trials based on protocol and given the circumstances, Marks said.

Still, in his experience, volunteers might say they want to participate, but once the rubber hits the road they might change their minds.

Even as vaccines are still in development, experts have started to warn about the publics willingnessor lack of willingnessto embrace a vaccine. About half of Americans said they planned to get a vaccine, according to a poll from late May.

The FDAs job number 1 is to fairly evaluate any programs that are submitted, he said. Also, communicating benefits and risks clearly is critical, he added.

Marks was previously on the U.S. government's Operation Warp Speed program, which is seeking to deliver hundreds of millions of doses in early 2021. But last month he stepped back to protect his independent regulatory power at CBER, according to Politico.

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Want to defeat COVID-19? Deliver a 70% effective vaccineand get 70% of people to take it, FDA official says - FiercePharma

A woman holds a small bottle labeled with a "Vaccine COVID-19" sticker and a medical syringe in this illustration taken April 10, 2020.

Dado Ruvic | Reuters

"Vaccine nationalism" is turning the search for a Covid-19 cure into an arms race, which will ultimately damage the economy and public health, experts have warned.

Analysts at Eurasia Group speculated that tension over a vaccine would heat up over the summer, predicting a battle for access that will stretch into 2021 or 2022.

"Countries rich and poor will engage in aggressive procurement efforts with significant political, economic and public health implications," they said in a note earlier this year. "Existing international institutions and agreements will struggle to minimize this 'vaccine nationalism.'"

The research group argued that some governments were already attempting to seize first access through large-scale investments.

"In the U.S., the Biomedical Advanced Research Development Authority (BARDA) has been spreading its investments across a number of vaccine candidates in an effort to reduce the financial risks for pharmaceutical firms and lock in priority access to a successful vaccine," the note's authors said.

BARDA has financial interests in Moderna's candidate vaccine and has invested in early research being conducted by French firm Sanofi and Britain's GlaxoSmithKline.

In May, the U.S. also invested $1 billion in AstraZeneca's potential vaccine, which is being developed by scientists at the University of Oxford. The British-Swedish pharmaceutical giant is aiming to produce 2 billion doses of the vaccine, with a view to roll 400 million doses out to the U.S. and U.K. by October.

AstraZeneca's vaccine has also received multimillion dollar investments from the U.K. government and a $843 million payment from some EU countries, who have secured access to the vaccine should it prove to be effective.

Meanwhile, the Canadian government's National Research Council has signed a deal with China's CanSino Biologics to manufacture its vaccine for clinical trials in Canada this summer giving Canada "an inside track on access," according to Eurasia's analysts.

Ian Goldin, professor of Globalisation and Development at the University of Oxford and ex-vice president of the World Bank, also warned there would be consequences if countries attempted to make the distribution of a vaccine a national enterprise.

"Some competition is healthy. You don't want to put all your vaccine development eggs into one basket because it might not work," he said. "But it shouldn't be that the country with the deepest pockets is able to protect its citizens but in poor countries people die."

Goldin said failing to inoculate the global population against Covid-19 would have long-term economic implications.

"As long as some parts of the world are suffering from the coronavirus, the global economy can't recover," he explained. "As long as it's present somewhere, the virus can mutate, it can move, and parts of the world economy will be devastated."

Speaking to CNBC's "Street Signs Europe" last week, Tara Raveendran, head of life sciences research at Shore Capital, said some researchers such as those at BioNTech and Moderna were developing mRNA vaccine technology, which could allow production to be scaled up easily.

However, she added that this might not be enough to offset certain countries' early-access agendas.

"This idea that countries that can afford to, will move first to secure a resource that's scarce and needs to be shared equally definitely raises issues," she said. "Non-profits have put frameworks in place to try and ease this burden, but it's something we as an industry need to address head on."

Raveendran noted that while the stockpiling of Covid-19 vaccines would make developing them a commercially viable endeavour, it could come at a cost to public health.

"If we resolve the situation in developed markets and there's still virus running rampant in other parts of the world, this is a problem for all of us," she told CNBC. "We need to be very aware of how we distribute a very limited resource at the beginning."

Goldin added that if the virus mutated in parts of the world that were unable to access the vaccine, Covid-19 would once again pose a threat to global public health, even for those who were immunized.

"We don't know how long these vaccines will last and how effective they'll be," he said. "So it's not a solution either on equity grounds or on self-interest grounds."

Distribution and supply challenges are "much more solvable" than actually finding a vaccine that works, according to John Rountree, managing partner at Novasecta, who told CNBC "we're a long way" from having an effective vaccine.

"Equitable access requires collaboration between pharma companies, governments, and patient-centric organizations, but I don't have any doubt that it will be solved," he said via telephone. "Pharma companies have interests in profitability for their shareholders. Governments have interests in having people treated. We're all in the same game, so it will happen."

Likening the vaccine development landscape to the space race of the 20th century, Rountree warned that vast government investments would not miraculously pave the way to an effective vaccine.

"Politicians can put aggressive timelines in, and it lends itself to putting a man on the moon," he said. "In the end, you're dealing with biology, which is a much more difficult problem than the engineering challenge of sending a man to the moon. And biology doesn't follow timelines."

President Donald Trump has voiced ambitions for a vaccine to be developed and distributed by the end of this year, in a project dubbed"Operation Warp Speed." However, medical experts including Dr. Anthony Fauci, the U.S. government's top infectious disease expert have cast doubt on Trump's goal.

There are currently at least 160 potential Covid-19 vaccines being tested around the world, according to the WHO.

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'Vaccine nationalism' could lead to the coronavirus devastating public health and the economy, experts warn - CNBC

BALTIMORE (WJZ) The worldwide race is on to find a COVID-19 vaccine, and Maryland is on the forefront of some of that research.

In the state, researchers at three companies are hard at work trying to create the first COVID-19 vaccine.

Among them is Emergent BioSolutions, a Global Life Sciences company headquartered in Gaithersburg, with facilities in Baltimore.

Senior vice president Syed Husain said the company has partnered with four fellow innovators, including Johnson & Johnson, in an effort to come up with a vaccine.

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Maryland itself is play a significant role where were directly contributing from a developmental and manufacturing standpoint toward these vaccines, Husain said.

The Gaithersburg-based company Novavax announced Tuesday it was getting $1.6 billion in federal money as part of Operation Warp Speed.

Gov. Larry Hogan congratulated the biotech company on Twitter.

Since day one, Ive said Marylands biohealth institutions would lead the charge to develop treatments and vaccines, the governor tweeted.

Novavax said it will use this funding for Phase 3 clinical trials to establish large-scale manufacturing and deliver 100 million doses of its vaccine candidate.

Lastly, the University of Maryland has also started testing experimental COVID-19 vaccines with funding from Pfizer.

No matter what company comes up with a vaccine, Husain said most importantly, it has to be safe and effective.

A timeline will be tied to how quickly a vaccine candidate can progress through the clinic and get regulatory approval.

Some are projecting results by the end of the year, while others think itll be closer to 2021.

Certainly, a lot needs to happen for something in the clinic to ultimately progress to a patient with an approved product, but theres certainly a lot of potential and a lot of activity thats happening in Maryland, Husain said.

For the latest information on coronavirus go to theMaryland Health Departments websiteor call 211. You can find all of WJZs coverage oncoronavirus in Maryland here.

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Maryland Biotech Companies At Forefront Of COVID-19 Vaccine Research - CBS Baltimore

Written by Dr Satchit Balsari, Dr Zarir Udwadia | New Delhi | Updated: July 11, 2020 11:09:48 am

Like a wedding guest piling food from a buffet onto their plate until there is no place left, doctors have been prescribing fistfuls of drugs when attempting to manage patients with Covid-19. We summarise based on current evidence from around the world, what scientists say works and does not, from among the treatments currently in vogue in India.

Azithromycin: This must be the most widely prescribed and misused antibiotic in this pandemic. Azithromycin, as with all other antibiotics, does not work in viral infections. Antibiotics are only warranted in patients who have evidence of a secondary bacterial infection as some hospitalised patients will have in the later stages of their disease. Indiscriminate use (as was the case even before the pandemic) in the hope that they will prevent bacterial infection only worsens antibiotic resistance, to which India is a frequent contributor.

Blood Thinners: Hospitalised Covid-19 patients have been observed to have a very high incidence of blood clots. There is current global consensus that all hospitalised Covid-19 patients will benefit from blood thinners injected daily just under their skin (like insulin injections). Though there is sound mechanistic reasoning, randomised controlled trials are awaited.

BCG & other existing vaccines: While the world eagerly awaits a new and SARS-CoV-2-specific vaccine, the use of existing vaccines (BCG, Polio, MMR vaccines) in the hope they will work is inappropriate. Trials are under way to see if they will boost innate immunity. We know that BCG has already been given at birth to all Indians, and it does not seem to have helped keep our case numbers low.

Vitamin C: More vitamin C may have been consumed than oranges since Covid-19 began! It doesnt work.

Vitamin D: A large meta-analysis just released shows that Vitamin D does not protect against Covid-19.

Favipiravir: This is an oral antiviral drug which was fast tracked by the Indian Drug Controller but is not yet approved in the EU or US. Its use should be restricted to mild or moderate infections only. Available data to support its use is sparse but Indian trials have just been completed and the results are awaited.

Hydroxychloroquine sulphate (HCQS): We now have compelling data from multiple large clinical trials including WHOs SOLIDARITY and the UKs RECOVERY trials to categorically say: HCQS does not work. Even Donald Trump may have stopped taking it by now and so should you.

Ivermectin: This is an anti-parasitic drug widely prescribed in India and parts of South America to treat infections from worms. There is no evidence it has any role in Covid-19. It should not be used.

Miscellaneous cures: The state machinery has been used to distribute unproven herbal and Ayurvedic potions (Ukalo), homeopathic drops (Arsenicum album), and treatments peddled by god-men. Anecdotes and observations do not constitute scientific evidence. In the absence of evidence generated from rigorously vetted clinical trials, the distribution of these substances must be condemned. Pushing unproven and supposedly harmless treatments and distributing them to hundreds of thousands is not only disingenuous, but provides people false hope, and risks them lowering their guard. There are no magic pills to boost immunity to fix years of malnutrition, stunting, obesity, and chronically inflamed lungs.

Oseltamivir: This is an antiviral agent prescribed for tempering symptoms from the virus that causes influenza. It has no role in treating Covid-19 infection which is caused by a coronavirus.

Plasma: Our blood is composed of cells and plasma. Plasma from those who have recovered from Covid-19 carries naturally acquired antibodies, and, when transfused to critically ill patients with Covid-19, may help improve outcomes. This form of therapy is being used across the globe and trials to access its efficacy are under way.

Remdesivir: An intravenously administered antiviral medication, it has been shown to be effective in well-designed studies. It seems to shorten recovery time and hospital stay but does not reduce the chance of death. It is currently to be used only in hospitalised patients with severe disease.

Steroids: The only drug so far shown to have a striking impact on mortality is an old and inexpensive one. Current evidence shows that dexamethasone can reduce deaths by one-third in patients with severe Covid-19 infection who need oxygen therapy or ventilators. Their use should, however, be restricted to hospitalised patients. If they are given too soon in the course of an infection, or given to someone with only a mild infection, they could prevent the bodys own immune system from fighting the virus effectively.

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Tocilizumab: This drug is an injection originally used in patients with rheumatoid arthritis. It is being widely used to counter the severe inflammation (cytokine storm) that occurs in some Covid-19 patients. Its use can increase the risk of bacterial infections, and it must therefore be used with caution, if at all, in carefully selected patients.

Zinc: This mineral is also commonly prescribed, despite there being no evidence that it is effective.

In conclusion, six months into the pandemic, we must therefore acknowledge four facts:

(Dr Zarir Udwadia is Consultant Chest Physician, PD Hinduja Hospital & Medical Research Centre, Mumbai. Dr Satchit Balsari is assistant professor in Emergency Medicine and in Global Health at Harvard Universitys medical and public health schools. )

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Explained: What works in Covid-19 treatment - The Indian Express

July 10, 2020 | :

by B. Denise Hawkins

When Meharry Medical College begins conducting COVID-19 vaccine trials in a few months, it will face a big challenge: how to inspire trust in the Black community that has reason to mistrust such interventions but stands to benefit the most.

Dr. James E. K. Hildreth (Photo: Meharry Medical College)

It is a big ask, acknowledges Dr. James E. K. Hildreth, the president and CEO of the historically Black college in Nashville, Tennessee. Yet, he said a successful vaccine is the best hope for African Americans and other people of color who remain the hardest hit by COVID-19. Now that Meharry is a part of the COVID-19 Vaccine Trials Network, getting them enrolled is a critical first step. And looking ahead to when a vaccine has been approved for widespread use, Hildreth said those most vulnerable for contracting the disease need to be ahead in line.

For now, though, Hildreth has no doubt that he and others at Meharry will need to work hard to dispel myths and allay fears among the local Black community who may trust Meharry with their care but not trust vaccines. Were starting to get inquiries from those who want to volunteer, Hildreth told Diverse. But interest and curiosity need to translate into plenty of Black participants who are willing to roll up their sleeves, and for the Meharry leader, the best way to inspire trust is to lead by example.

Im going to be one of the first, if not the first, in line to get vaccinated at Meharry, Hildreth said.

For the veteran and award-winning infectious disease expert, this was an easy decision to make.

I dont know a lot about a lot of things, but I know a lot about viruses and vaccines, Hildreth said. Its hard to imagine how [vaccines] couldnt be safe, especially when some of the old-fashioned approaches to developing [COVID-19 drugs] are being used. The science behind vaccines is very mature.

Still, convincing Black people that they are crucial volunteers and that vaccines are generally safe, have saved lives and dont cause diseases will be a challenge, Hildreth added. Black Americans are well aware of the infamous Tuskegee Experiment, which involved White, public health doctors letting unsuspecting Black men die from syphilis while withholding a drug that could treat them. Many also know about the case of Henrietta Lacks, a young Black mother in Baltimore whose cancer cells scientists and drug companies used for decades without her permission and profited from them.

A poll conducted by The Associated Press-NORC Center for Public Affairs Researchfrom May 14-18 found that 49% of Americans overall said they plan to get a COVID-19 vaccination when one is available, while 31% of respondents said they were unsure if they will get vaccinated. The remaining 20% said a flat no.

A participants race reflected some of the biggest differences in the polls findings. For example, Black Americans were more likely than other racial and ethnic groups to say they wont get the vaccine if it becomes available. The survey also found that White Americans, more than any other group, were most willing to get the vaccine, outpacing Black Americans 56% to 25%. Of Hispanics, 37% said they will get a vaccine if it is available.

What will help encourage Black community members to volunteer for COVID-19 vaccine trials is the fact that Hildreth and many others who will be conducting the human trials at Meharry are Black. Black representation among researchers and those administering the tests will go a long way to build trust in Black communities and increase participation, a professor at the Johns Hopkins University School of Medicine told Diverse last month. Having Meharry in the forefront on recruitment in the Black community is a really positive move, said Dr. Namandj Bumpus, a professor and chair of the Department of Pharmacology and Molecular Sciences at the Johns Hopkins medical school.

Hildreth concurs with Bumpus assessment. Meharry and Meharrians are trusted in the communities we serve, which have a history of abuse at the hands of Americas medical establishment. We understand the subtle, yet critical cultural differences that have long been overlooked by mainstream providers, creating deep fear and distrust. We can deploy quickly, we know where to go, and we will be welcomed, he told a virtual convening of the House Ways and Means Committee in May.

Now, hes working overtime to connect those most vulnerable to COVID-19 with a drug candidate that may be the best hope to protect them. It could likely be the first vaccine approved for use in the United States or globally. The candidate hes referring to is AstraZenecas experimental COVID-19 vaccine being developed by research partners at the University of Oxford in England. With Oxford scientists out of the gate early on development, their drug is now one of only three COVID-19 vaccine candidates in late-stage Phase III trials, which, at this level, means scientists are testing whether it will be effective in humans. Most other vaccines being developed for COVID-19, Hildreth said, are still in Phase I and Phase II, testing for safety.

Behind the AstraZeneca-University of Oxford drug is the universitys strong vaccine research footprint, said Hildreth who recalls the robust research that was underway on a host of vaccines, including influenza, in the late 1970s when he was a graduate student at Oxford. Black people and those with underlying health conditions like diabetes and hypertension have been disproportionately ravaged by COVID-19. But they are exactly the ones who Hildreth is eager to recruit by the end of the summer for this and other drug trials. According to drugmaker AstraZeneca, it will start its vaccine trial with 30,000 people in the United States.

In addition to the drug being developed at Oxford, Meharry will make five other COVID-19 vaccine candidates available for human trials through participation in Operation Warp Speed, a public-private partnership the White House formed to fast track the development, testing and manufacturing of a vaccine to prevent the spread of COVID-19. In a pandemic, said Hildreth, a COVID-19 vaccine will ultimately be the thing that allows us to get to a new normal and new way of life.

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Meharry Is Enlisting Volunteers for COVID-19 Vaccine Trials... - Diverse: Issues in Higher Education

Posted: Jul 10, 2020 / 05:40 PM EDT / Updated: Jul 10, 2020 / 05:59 PM EDT

(WSYR-TV) When a coronavirus vaccine becomes available, which Americans will be the first to get it? Federal health officials are working on that right now.

The CDC and an advisory committee of outside health experts are debating giving early access to groups that face a high risk.

According to a preliminary plan, any approved vaccines would be offered to vital medical and national security officials first and then to other essential workers and those considered at high risk.

Those considered to be high risk include the elderly and people with underlying conditions.

They are also looking at whether teachers and pregnant women should be moved to the front of the line.

Agency officials and advisers are also considering putting African American and Latino people, who have disproportionately fallen victim to the virus, on the list to get the vaccine first.

There are 140 vaccines being developed around the world. We are expected to have approval early next year and then it could take months to distribute them to Americans.

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Family Healthcast: Who will get the COVID-19 vaccine first when it comes out? - WSYR

Human Immuno Deficiency virus (HIV), which causes AIDS (Acquired Immuno Deficiency Syndrome) is one of the deadliest virus affecting 36.9 million people globally which caused rampant infection ever since it started to spread in the 1980s. While many countries, including India, have managed to lower down the spread of the infection with a host of measures, the world is still far from seeing a vaccine being developed for the infection. The most recent studies were underway in China, where scientists conducted trials using a CRISPR technology but no developments have been made on the same.

There are also a lot of challenges with developing an effective HIV vaccine. HIV virus targets the immune system in a lot of different ways, so it's not entirely possible to develop one with full efficacy.

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Coronavirus vaccine: 4 infections apart from COVID-19 which still don't have a vaccine - Times of India

BOCA RATON, Fla.--(BUSINESS WIRE)--Modernizing Medicine, a leading healthcare technology company, is hosting a new installment in its thought leadership webinar series. The session, World War C: Contact Tracing and the Hunt for a Vaccine, will take place virtually on Tuesday, July 14 at 7 PM EDT. Those interested can register here.

Modernizing Medicines Chief Medical and Strategy Officer and co-founder, Michael Sherling, MD, MBA, will speak with special guest, Jerome Kim, MD, director general of the International Vaccine Institute (IVI), about the latest pandemic news. With so many unknown variables and uncertainty, Dr. Kim will help shed light on the COVID-19 vaccination development timeline as well as how contact tracing plays a significant role in helping to combat this global pandemic.

Dr. Kim is an international expert on the evaluation and development of vaccines. He is a recognized leader in HIV vaccine development and was named one of the 50 Most Influential People in Vaccines in 2014 by Vaccine Nation.

Dr. Kim stated that: The novel coronavirus has had unprecedented impact on our lives, economy and our expectations. Accelerating vaccine development is one of those necessary adjustments. While a vaccine typically takes 5-10 years to develop, its now all hands on deck to release a COVID-19 vaccine that prevents infection and/or disease as quickly, safely and fairly as possible.

During this virtual event, Dr. Kim will share his expertise on the fight against COVID-19, including:

Dr. Michael Sherling shared that: As physicians and healthcare professionals, we are all doing our best to treat patients in an uncertain world. I look forward to speaking with Dr. Kim and helping to provide a platform to share his invaluable knowledge with others in the healthcare community.

As we continue to navigate the uncertainty of the COVID-19 pandemic, its important to rely on the power of information. To register for this event, click here.

About Modernizing Medicine

Modernizing Medicine and its affiliated companies empower physicians with suites of mobile, specialty-specific solutions that transform how healthcare information is created, consumed and utilized to increase practice efficiency and improve patient outcomes. Built for value-based healthcare, Modernizing Medicines data-driven, touch- and cloud-based products and services are programmed by a team that includes practicing physicians to meet the unique needs of dermatology, gastroenterology, ophthalmology, orthopedics, otolaryngology, pain management, plastic surgery and urology practices, as well as ambulatory surgery centers. For more information, please visit http://www.modmed.com. Connect with Modernizing Medicine on our Blog, Facebook, LinkedIn and Twitter.

About the International Vaccine Institute (IVI)

The International Vaccine Institute (IVI) is a nonprofit inter-governmental organization established in 1997 at the initiative of the United Nations Development Programme (UNDP). Headquartered in Seoul, South Korea, IVI was the first international organization hosted by Korea. IVI has 35 signatory countries and the World Health Organization (WHO) on its treaty, including Korea, Sweden and India as state funders.

Our mandate is to make vaccines available and accessible for the worlds most vulnerable people. We focus on infectious diseases of global health importance such as cholera, typhoid, shigella, salmonella, schistosomiasis, Group A Strep, Hepatitis A, HPV, TB, HIV, MERS, COVID-19, as well as antimicrobial resistance. For more information, please visit https://www.ivi.int

About Dr. Jerome Kim

Jerome Kim, MD, is the Director General of the International Vaccine Institute (IVI) and an international expert on the evaluation and development of vaccines. His depth and breadth of scientific experience spans basic research through advanced clinical development. Dr. Kim was Principal Deputy and Chief of the Laboratory of Molecular Virology and Pathogenesis at the U.S. Military HIV Research Program. He led the Armys Phase III HIV vaccine trial (RV144) which was the first demonstration that an HIV vaccine could protect against infection. He has authored over 250 publications and received the John Maher Award for Research Excellence from the Uniformed Services University of the Health Sciences in 2013.

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Modernizing Medicine to Host Must-Attend Event on COVID-19 Vaccine Timeline and Contact Tracing with Special Guest Jerome Kim, MD - Business Wire

I believe they are very safe, saidDon Putzier, M.D., a pediatrician at the Mankato Clinic Childrens Health Center. They are extensively tested. When a vaccine is developed, typically they go through animal trials first, followed by human trials until they determine it is safe and effective for whatever age we want to give the vaccine for.

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Expert weighs in on a potential COVID-19 vaccine and herd immunity - KEYC

Medical technology company will make millions of syringes for COVID-19 vaccine in Nebraska  NTV

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Medical technology company will make millions of syringes for COVID-19 vaccine in Nebraska - NTV