Category: Covid-19 Vaccine

LONDON (KWTX) A team from Oxford University announced Sunday that its close to having a COVID-19 vaccine ready for mass production.

That process typically takes several years, but the group said its vaccine will be ready for human testing by the fall.

Dr. Peter Marks, who serves as the Director of the Center for Biologics Evaluation and Research with the U.S. Food and Drug Administration said in a teleconference last week that whichever candidate makes it to production has to be available in mass quantities.

Ultimately, were not talking about vaccinating, you know, a few hundred thousand individuals, Marks said.

Were talking about vaccinating a few hundred million people in this country alone, and a few billion people globally.

Development of a vaccine typically takes so long because of the steps involved in getting it ready for public use, and the clinical trial phase.

Researchers say the more reliable the data on a vaccines effectiveness, the better.

But Dr. L.J. Tan, who serves as the chief strategy officer with the Immunization Action Coalition said there will variances in the effectiveness simply because there are vast differences among the adult populations in the world.

He said theyre taking that into account when it comes to choosing a vaccine for mass production.

Speed to a vaccine here is important, Tan said.

And I think, you know, we dont want to have perfection be the enemy of the good in this case.

Tan went on to explain that normally, it may take years of trials before a vaccine reaches the population, but during the pandemic, scientists can fast-track this process by doing as many of the necessary steps as possible in parallel.

The vaccine would still need approval from the federal government to be administered.

Both Marks and Tan say that can also be fast tracked in an emergency situation.

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University team says it's close to having a COVID-19 vaccine - KWTX

If you are young and healthy, would you volunteer to be infected with COVID-19 to help quickly develop a vaccine? With the pandemic sweeping the globe, its a reasonable question to be asking.

A group of 35 lawmakers, led by Reps. Bill Foster, D-Ill., and Donna Shalala, D-Fla., are urging the Food and Drug Administration to take more risks including infecting humans to shrink the time it takes to develop and approve a vaccine.

We are trying to give the FDA political cover to be somewhat more aggressive on the rapid rollout of vaccines than they would under normal circumstances, Foster told the Chicago Sun-Times on Tuesday.

The typical approval time for vaccines of normal diseases is 18 months to several years. Foster told me testing a COVID-19 vaccine using infected humans could cut that time to two or three months.

Foster, a physicist, and Shalala, who served as Health and Human Services Secretary under former President Bill Clinton, laid out the case for rethinking the risk/benefit ratio involved in COVID-19 human drug testing in a letter to HHS Secretary Alex Azar and FDA Commissioner Stephen Hahn.

They want the FDA to embrace expedited procedures for testing, approval and use of COVID-19 vaccines.

The pandemic, Foster and Shalala said in their letter, means a reevaluation of the essential tradeoff of having new drugs quickly even if the effectiveness and side effects are not fully known at the time of deployment.

In normal times, infecting human subjects to develop a drug is controversial, and while it has been done, it is rare. The Foster/Shalala letter is intended to let the FDA know that Congress or at least 35 House members will have their back.

The 35 included two Republicans and a total of five Illinois Democrats: Foster, Sean Casten, Danny Davis, Bobby Rush and Jesus Chuy Garcia.

We write to assure you that Congress understands that a more risk-tolerant development process is likely appropriate in the case of a COVID-19 vaccine, the letter said.

They suggest running two vaccine trials in parallel: One, the time consuming traditional way, not involving infecting anyone while at the same time deliberately infecting volunteers. Some infected volunteers would receive a vaccine; others a placebos.

We urge you to consider these and other options, provided they proceed with the principle of informed consent of truly voluntary subjects and backed by the best available science.

Any volunteer would head into a test knowing there is no widely accepted cure for COVID-19. There is no zero risk path here, Foster told me. Still, Anytime any new drug is approved theres a risk.

The discussion of infecting humans is done in the context that COVID-19 is a fire burning through the developed world right now and very soon the developing world, Foster said. ...So the benefits of getting a vaccine approve early is enormous.

An article in the April 3 edition of Science considered the ethics of using human volunteers to speed a vaccine.

Seema Shah, a bioethicist at Northwestern University, noted her misgivings in the article and said they could be addressed if the volunteers were people already trained to take on these risks, like health care workers.

She added, If were going to say were making an exception to the standard way we do things, then we really have to get that right.

Foster, from Naperville, who represents the 11th Congressional District, said young and healthy volunteers would be recruited because they would have a low probability of dying in a controlled testing situation. Also, You can get the right racial mixture so you can actually resolve some of these issues, why is it African-Americans are dying at a much higher rate.

The volunteers would have state of the art medical care if they got sick.

Said Foster, Its very much like the military, asking for volunteers for a very dangerous mission. The COVID-19 vaccine volunteers will be heroes to humanity and they will be responsible for saving thousands and maybe millions of lives.

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Would you volunteer to be infected with COVID-19 to develop a vaccine? - Chicago Sun-Times

With much of the world living in lockdown, the spread of the new coronavirus, SARS-CoV-2, that was first detected in China late last year is beginning to slow in some places. As of April 19, 2.4 million had been infected and 165,000 killed by COVID-19, the disease caused by the virus.

While a safe, effective vaccine is still more than a year away, researchers are rushing to repurpose existing drugs and non-drug therapies as well as testing promising experimental drugs that were already in clinical trials.

Even moderately effective therapies or combinations could dramatically reduce the crushing demand on hospitals and intensive care units, changing the nature of the risk the new pathogen represents to populations and healthcare systems. New drugs, together with new diagnostics, antibody tests, patient- and contact-tracing technologies, disease surveillance and other early-warning tools, mean the anticipated next 'wave' of the global pandemic does not have to be nearly as bad as the first.

More than 70 vaccine candidates are also in development around the world, with at least five in preliminary testing in people. Here are some of the drugs, vaccines and other therapies in development:

1. GILEAD SCIENCES: Remdesivir

Type: Drug. Status: Repurposed experimental. Early results: 0-3 Months.

Antiviral drug, originally developed to combat RNA viruses including respiratory syncytial virus. At least 13 trials underway in China, Europe and the United States with preliminary results from two Chinese trials expected as soon as April 2020. A February assessment by the WHO flagged this candidate as the most promising for battling COVID-19.

Initial data are expected to come from studies of patients with relatively severe COVID-19. Because antivirals work best when patients are healthier, those results may show limited effectiveness.

2. Hydroxychloroquine / chloroquine

Type: Drug. Status: Repurposed. Early results: 0-3 Months.

Malaria drug also believed to have antiviral activity. Blocked SARS-CoV-2 entry into cells in an in-vitro experiment. In one small French study, some COVID-19 patients showed improvements but there was no way to know if the drug was the reason. Results published in April from another study in France and one in China found no benefit in patients treated with the drug. Dozens more clinical studies are underway around the world.

3. ROCHE: Actemra (tocilizumab)

Type: Drug. Status: Repurposed. Early results: 0-3 Months.

Monoclonal antibody approved for rheumatoid arthritis and also for treating the "cytokine storm" immune overresponse in cancer patients. Fifteen registered trials in China, Europe and the United States are testing it on COVID-19 patients, alone or in comparison to other therapies. One French trial is looking at 28-day effects on COVID-19 in patients with advanced or metastatic cancer.

4. SANOFI, REGENERON PHARMACEUTICALS: Kevzara (sarilumab)

Type: Drug. Status: Repurposed. Early results: 0-3 Months.

Monoclonal antibody approved for inflammatory arthritis, and in trials targeting the "cytokine storm" immune response in severely ill COVID-19 patients. Regeneron's chief scientific officer has said initial data on effectiveness could come by late April.

5. NOVARTIS, INCYTE: Jakavi (ruxolitinib)

Type: Drug. Status: Repurposed. Early results: 0-3 Months.

Developed to treat inflammatory and autoimmune diseases, and in late-stage development as a cream for atopic dermatitis. One trial each in Canada and Mexico will test the drug in COVID-19 patients with severe respiratory symptoms associated with the "cytokine storm" immune response, with preliminary results expected by June 2020. In the United States, Novartis established a managed access program for use in severe/very severe COVID-19 illness on April 7.

6. MODERNA/NIAID: mRNA 1273

Type: Vaccine. Status: Experimental. Early results: 0-3 Months.

RNA vaccine made with messenger-RNA (mRNA) encoding the spike protein of SARS-CoV-2 encapsulated in a lipid nanoparticle. The phase 1 trial with 45 subjects aged 18-55 at three locations in the United States will evaluate the vaccine's safety and provide early data on the immune response it induces. Trial completion is anticipated to be June 1, 2020.

Type: Non-drug therapy. Early results: 0-3 Months.

Blood plasma from recovered COVID-19 patients is transfused into patients who are currently ill, in the hope the freshly-made antibodies it contains will help fight the virus. The method has been used for more than 100 years and carries little risk of harm or side effects. Small case studies suggest it may help reduce virus levels, and controlled trials are in progress in China, Europe and the United States to gather stronger evidence for a benefit. Results published in April from a study in 10 patients with severe illness in China found significant improvement compared to similar patients who did not receive the treatment.

Immediately available and already in limited use, but supply of plasma from recovered patients may not be sufficient to meet all needs. Further studies of recovered patients must also determine if everyone produces a full immune response to the infection, including "neutralizing antibodies," at sufficiently high levels to become donors.

8. ABBVIE: Kaletra (lopinavir/ritonavir)

Type: Drug. Status: Repurposed. Early results: 0-3 Months.

Antiviral combination used to treat and prevent HIV infections. More than twenty trials around the world are testing the drug as a COVID-19 treatment or post-exposure prophylaxis for people with high-risk close contact with a confirmed case. Initial results expected as soon as May 2020.

One randomized controlled trial in China published results in March showing no differences in viral load or 28-day mortality among 199 patients. Median time to clinical improvement was one day shorter in patients taking the drug. However the same investigators, doctors at Jinyintan Hospital in Wuhan, said in April that they believe Kaletra, as well as a second drug, bismuth potassium citrate, helped some of the COVID-19 patients they treated.

9. CHONGQING PUBLIC HEALTH MEDICAL CENTER, CHONGQING SIDEMU BIOTECHNOLOGY TECHNOLOGY CO.,LTD: NKG2D-ACE2 CAR-NK cells

Type: Non-drug therapy. Status: Experimental. Early results: 0-3 Months.

NKG2D receptor for the immune system's natural killer (NK) cells paired with the ACE-2 receptor that the coronavirus uses to enter human cells. A multicenter Phase 1/2 trial in 90 patients is testing whether this cell therapy can prevent the SARS-CoV-2 virus from entering cells and multiplying, and will look at efficacy over 28 days in patients with severe or critical COVID-19 pneumonia.

Type: Vaccine. Status: Experimental. Early results: 0-3 Months.

Novavax said its Matrix-M adjuvant would be used with the vaccine candidate - NVX-CoV2373 - to enhance immune responses. Trials in 130 adults is expected to begin in mid-May with preliminary immunogenicity and safety results in July, according to the company.

Strong immunogenicity in animal tests, but might require two doses in humans, which would limit supply.

11. APEIRON BIOLOGICS: RhACE2 APN01

Type: Drug. Status: Experimental. Early results: 3-6 Months.

A recombinant human angiotensin converting enzyme 2 (rhACE2) under Phase-2 clinical development in ALI (Acute Lung Injury) and PAH (Pulmonal arterial hypertension). This synthetic version of the human protein that the novel coronavirus uses to enter cells is being tested in Austria to see if it can block viral entry and decrease viral replication in COVID-19 patients, reducing deaths or need for mechanical ventilation. Preliminary results from the trial that was announced on April 2 are expected in September 2020.

12. SHENZHEN GENO-IMMUNE MEDICAL INSTITUTE: Lentiviral Minigene Vaccines (LV-SMENP)

Type: Vaccine. Status: Experimental. Early results: 3-6 Months.

Engineered minigenes encoding viral antigens; lentiviral vector designed to infect dendritic and T cells to induce immunity. The trial in 100 adults in Shenzen, China, is expected to be complete by July 31, 2020.

13. MURDOCH CHILDREN'S RESEARCH INSTITUTE; UMC UTRECHT: BCG tuberculosis vaccine

Type: Vaccine. Status: Repurposed. Early results: 3-6 Months.

Bacillus Calmette-Gurin tuberculosis vaccine that induces a broad innate immune-system response, which has been shown to protect against infection or severe illness with other respiratory pathogens. Large trials in Australia and the Netherlands are testing whether using BCG to rev-up immune defenses in health workers and the elderly reduces unplanned absenteeism, respiratory illnesses including COVID-19, severe illnesses and deaths. Two additional trials by the Max Planck Institute in Germany of a TB vaccine candidate, VPM1002, are in the works.

14. INOVIO PHARMACEUTICALS, COALITION FOR EPIDEMIC PREPAREDNESS INNOVATIONS (CEPI): INO-4800

Type: Vaccine. Status: Experimental. Early results: 3-6 Months.

DNA plasmid vaccine delivered into the skin via a patch-style electroporation device. A clinical trial launched on April 3 could yield preliminary data by late summer, according to the company, which has said it can manufacture 1 million doses by year-end for additional trials and emergency use.

15. UNIVERSITY OF AARHUS, DENMARK: Camostat mesylate

Type: Drug. Status: Repurposed. Early results: 6-12 Months.

Protease inhibitor licensed in Japan and South Korea to treat chronic pancreatitis. In vitro experiments found it blocks a mechanism SARS-Cov-2 uses to enter human cells. As of early April, an estimated 180 COVID-19 patients aged 18-110 were being recruited at nine locations in Denmark for a phase 2a trial that will examine 30-day changes in disease severity and mortality, with results expected by December 2020. The University of Tokyo also announced plans for a trial of camostat mesylate and a related drug, nafamostat mesylate, starting as early as April 2020.

Type: Drug. Status: Experimental. Early results: 6-12 Months.

Monoclonal antibody targeting complement activation product C5a. Designed to block a mechanism of inflammation, the drug is also in clinical trials for Hidradenitis Suppurativa, ANCA-associated vasculitis and Pyoderma Gangraenosum. In early April, a trial in the Netherlands launched to test IFX-1 in patients with severe COVID-19 pneumonia, with preliminary results expected in late October 2020.

17. CANSINO BIOLOGICAL INC./BEIJING INSTITUTE OF BIOTECHNOLOGY: AD5-nCov

Type: Vaccine. Status: Experimental. Early results: 6-12 Months.

Non-replicating viral vector. A single-center phase 1 trial with 108 subjects aged 18-60 in Wuhan, Hubei, China, started in March to test the safety and immune responses generated by a recombinant vaccine that uses another respiratory virus, adenovirus, as a vector. On April 12, a randomized controlled phase 2 trial with 500 participants launched to test varying doses against placebo. Phase 1 completion is in late December 2020, and phase 2 results are expected in January 2021.

18. IMPERIAL COLLEGE LONDON: Aspirin, Clopidogrel, Rivaroxaban, Atorvastatin, Omeprazole

Type: Drug. Early results: 9-12 Months.

Trial of cardioprotective drugs to prevent direct damage to the heart muscle that appears to drive the severity of COVID-19 in certain patients as well as their likelihood of needing invasive critical care. The trial will include more than 3,000 patients in the United Kingdom, with a completion date of March 30, 2021.

19. UNIVERSITY OF OXFORD: ChAdOx1

Type: Vaccine. Status: Experimental. Early results: 12-18 Months.

Non-replicating chimpanzee adenovirus vector. Phase 1/2 trial with 510 subjects aged 18-55 at four centers in the United Kingdom. The trial will test safety and immunogenicity of one or two doses of the vaccine, and is expected to be completed in May 2021.

20. Serology / Antibody Testing

Type: Testing. Status: Experimental. Early results: 0-12 Months.

Governments and academic groups have started to test blood for antibodies indicating that a person has been exposed to the new virus, with or without showing symptoms. The presence of antibodies indicates past infection, but separate, ongoing research is needed to know what type and concentration of virus-neutralizing antibodies protect against a new infection, whether all infections produce a full antibody response, and how long protection might last.

Wide serology testing for antibodies will soon provide a broader understanding of the scope and dynamics of the pandemic, help identify which recovered patients may have some immunity to reinfection and for how long, and also help identify the neutralizing antibodies that could become templates for monoclonal antibody therapies as well as models for desired responses from a vaccine candidate. Data from serology testing are expected to begin appearing within weeks.

Early data on COVID-19 patients in China suggests that most develop varying amounts of antibodies in response to infection. One pre-publication report analyzed plasma from 175 patients and found that a sign of inflammation correlated with higher antibody titers and that younger patients were less likely to produce large amounts of antibodies.

Experts think instances of "reinfection" in recovered patients are more likely relapses in patients whose bodies had not cleared the virus. Data is still lacking on whether mild or symptomless infections generate meaningful antibody responses or protection.

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When will a vaccine and treatment be ready for COVID-19? - World Economic Forum

Good, a COVID-19 Vaccine is in Development Will it Be Accessible to All Americans?  Health Affairs

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Good, a COVID-19 Vaccine is in Development Will it Be Accessible to All Americans? - Health Affairs

A potential Covid-19 vaccine will be tested on people for the first time this week, it has been revealed.

The Health Secretary, Matt Hancock, made the revelation as he announced further funding for trials of two leading vaccine projects in the UK.

He said two projects based at Oxford University and Imperial College London were working on a possible vaccination jab to protect people from the virus.

And speaking at today's daily Downing Street briefing, Mr Hancock said both were making "rapid progress."

To help with this, he said Imperial College will receive 22.5 million to support its phase two clinical trials and Oxford will be granted 20 million to fund its clinical trials.

The Oxford project had in conjunction with the regulator "accelerated" the trials process and, as a result, the possible vaccine would be trailed in people from this Thursday, he said.

The government was also investing in manufacturing capability so that if either of these vaccines safely work they can make it available to the British people "as soon as humanely possible", he added.

Mr Hancock said the process for finding a vaccine would take trial and error but he has told UK scientists leading the search he would back them to the hilt and give them every resource they need in order to succeed.

"In the long run the best way to defeat coronavirus is through a vaccine," Mr Hancock said.

"This is a new disease. This is uncertain science but I am certain we will throw everything we've got at developing a vaccine.

"The UK is at the forefront of the global effort.

"We have put more money than any other country in the global search for a vacccine.

"And for all the efforts around the world, two of the leading vaccine developments are taking place here at home at Oxford and Imperial.

"Both of these promising projects are making rapid progress. And I've told the scientists leading them we will do everything in our power to support them.

"In normal times reaching this stage would take years and I am very proud of the work taken so far."

He later added: "The upside of being the first country in the world to develop a successful vaccine is so huge that I am throwing everything at it."

On Sunday, Sarah Gilbert, Professor of Vaccinology at Oxford University said of their project: "The prospects are very good, but it is clearly not completely certain."

She added they had already been given permission to recruit volunteers, take blood tests, explain the process and check their health status.

She said there were many crucial stages to the vaccine development.

These start with immunising healthy 18 to 55-year-olds, before moving into older age groups, looking at the safety and immune response to the vaccine.

"That's important because it's the older population that we really need to protect with the vaccine," she said.

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Potential Covid-19 vaccine will be tested on people for the first time this week, Matt Hancock says - Manchester Evening News

Kamran Jebreili/Associated Press

Tennis star Novak Djokovic spoke out against vaccination Sunday and said he would not want to be "forced" to take a vaccine to travel amid the COVID-19 pandemic.

"Personally, I am opposed to vaccination, and I wouldn't want to be forced by someone to take a vaccine in order to be able to travel," Djokovic said in a live Facebook chat. "But if it becomes compulsory, what will happen? I will have to make a decision. I have my own thoughts about the matter, and whether those thoughts will change at some point, I don't know.

"Hypothetically, if the season was to resume in July, August or September, though unlikely, I understand that a vaccine will become a requirement straight after we are out of strict quarantine, and there is no vaccine yet."

A vaccine for COVID-19 is believed to be at least a year away from being made widely available. Several are currently in the testing stage.

Djokovic did not delve into his reasoning for being against vaccination. There is nomedical reasonwhy vaccines would be considered unsafe.

Wimbledon already announced its cancellation, and the French Open has been pushed back to a September start due to the pandemic. It's unclear when either the ATP or WTA would resume. Many tournaments require international travel, which has been heavily restricted as more than2.3 million peoplehave been diagnosed with the virus.

All scheduled tournaments have beenpostponedor canceled until at least July 13.

Read more:

Novak Djokovic 'Opposed to Vaccination,' Conflicted If 'Forced' for COVID-19 - Bleacher Report

Youve all heard the rosiest scenarios by now.

Vaccines are racing through clinical development at unheard-of speed, helped along by regulators working round the clock to beat Covid-19. And manufacturers have been laying the groundwork for mass production ahead of Phase I results.

The first wave of jabs and meds could break in a matter of months. With the NIH endorsing such remarks as Well have a vaccine by September, everyone from lawmakers to investors and the general public have been willing to buy into the notion that salvation lies right around the corner.

Then along comes a prominent analyst to pour a bucket of cold water on your hope of turning the tide by Christmas.

SVB Leerinks Geoffrey Porges took stock of the promise of global pandemic relief and offered to burst that little bubble for free.

For Porges, the only thing that lies around the corner is another corner. And then more corners. The path to a vaccine is long and hard, he notes. And the reality of that should be factored in as we size up the future.

In our experience it is very unlikely that we will have a general use vaccine in the 6-18 month accelerated timeframe that is being discussed. We believe that a 2-3 year timeline is the most optimistic for seeing a general use vaccine introduced, and as importantly, in the remote possibility that an approved, effective, safe general use vaccine was available a year from now, it would still take several years to confer sufficient herd immunity to prevent endemic spread of COVID19. We believe that achieving herd immunity sufficient to prevent epidemic spread is likely to occur in 2023 or 2024, given a highly accelerated timeline for vaccine development including demonstration of safety and efficacy in humans, and then design, development and implementation of a mass immunization program sufficient to get to a 70-80% immune threshold.

And that, he adds, is his optimistic projection. It could be much, much worse.

Sure, there are more than 70 vaccine programs going on now. But for Porges, if you add it all up, its like handing someone a dart and giving them 1 chance to hit a bulls eye at 24 feet 3 times the regulation distance. Hes also not enthusiastic that the closest vaccines to reality like the mRNA vaccines can pass muster quickly, as they are completely unproven.

Add to that a new virus we dont completely understand and you get a better idea of where Porges is coming from.

We do have the luxury of many different shots on goal with 70+ programs underway (to mix our sporting metaphors), but each one of these only has the same low probability and most of them cant deliver on the optimistic timelines now dominating policy makers and investors outlooks.

The only real shot at getting a vaccine into fast use is by requiring people to take a shot of something that no one knows the full story on with safety and efficacy iffy at best, notes the analyst. And that includes immunizing low-risk people for the sake of the older generation.

So give it 2-3 years for an effective vaccine, then 1-3 years for herd immunity. John Carroll

Almost a month after indicating its looking into testing its star C5 inhibitor Soliris for hospitalized patients with Covid-19, Alexion is going straight into Phase III with its follow-up drug, Ultomiris. The study will involve around 270 patients suffering from severe pneumonia, acute lung injury or acute respiratory distress syndrome and investigate whether Ultomiris can help them survive past 29 days.

The decision was based on early anecdotal information available from compassionate use cases in multiple countries as well as preclinical data suggesting that inhibition of terminal complement can lower cytokine and chemokine levels, thereby reducing lung inflammation.

In the Phase III trial which will include a control arm receiving best supportive treatment investigators will also assess the need for mechanical ventilation, oxygenation, duration of ICU stay and hospitalization, in addition to safety as secondary endpoints. Meanwhile Alexion is still running an expanded access program in the US and France for Soliris. Amber Tong

Apart from developing an efficacious and safe vaccine, a companys ability to manufacture the vaccine swiftly is paramount. Experts, including NIAID director Anthony Fauci, have stressed that the best strategy is for makers to shore up manufacturing even before they have concrete evidence of efficacy so that vaccines can be deployed quickly and widely if proven to be safe and potent.

Now, chiefs of pharmaceutical companies are asking governments to work together and provide substantial funding to assist with shoring up production. Industry alone cant provide all the investment needed now for billions of doses, Sanofi EVP David Loew said in an interview with the Financial Times.

Apart from vaccines, there is a global desperation for raw materials for existing treatments being repurposed and testing. Of particular concern are developing poorer nations, whose access to medical supplies is limited by scanter resources. Executives also worry that the Covid-19 situation will echo what happened in the aftermath of previous outbreaks, such as Ebola and the 2009 flu pandemic as the dust began to settle, companies struggled to maintain funding to develop potential drugs and vaccines for future outbreaks after governments cut them off.

The investment required is too large for any company, said Takeda chief Christophe Weber to the FT. Society will have to finance this huge investment. My fear is the same as after the flu pandemic, when everybody loses interest. Natalie Grover

On Sunday, White House advisor Peter Navarro took to Fox News to accuse China of taking a suite of actions to worsen the ongoing coronavirus crisis.

First of all, the virus was spawned in China. Second of all, they hid the virus behind the shield of the World Health Organization. The third thing they did was basically hoard personal protective equipment and now theyre profiteering from it, Navarro said on Fox News program Sunday Morning Futures.

The outspoken critic of China, who has been tasked by President Trump to work on supply issues relating to the pandemic, on Monday suggested on Fox News that the country is withholding data about early coronavirus infections in order to be the first to develop a vaccine.

One of the reasons that they may not have let us in and given us the data on this virus early, is theyre racing to get a vaccine and they think this is just a competitive business race, its a business proposition so that they can sell the vaccines to the world, he said.

The race to develop a vaccine has heated up, with Chinas CanSino as one of a handful of developers with a vaccine in human testing. Natalie Grover

A new study from Brazil, which suggested the combination of hydroxychloroquine and azithromycin had a significantly positive impact on early-stage suspected Covid-19 cases, was posted as a preliminary manuscript draft on Dropbox last week.

On Monday, the trial was suspended by the National Commission for Ethics in Research (Conep) after the agency discovered that testing was initiated before the company, a So Paulo-based hospital chain, received the greenlight to carry out the research. The researchers in charge were summoned for a hearing this Monday afternoon with the agency to provide clarification on suspected irregularities, according to a report.

There were a number of inconsistencies identified. For one, researchers had told Conep that patients with a confirmed diagnosis of Covid-19 would be included in the trial, but the manuscript released suggested that participants displaying flu-like symptoms without confirmed Covid-19 infections were included in the trial. Initially, the researchers also indicated the trial would enroll 200 participants, but the manuscript the number was closer to 700, the report said. Natalie Grover

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UPDATED: Covid-19 roundup: The pandemic bear You think a vaccine and herd immunity are just months away? Dream on, says biotech analyst; plus more -...

Got a minute? Here's how you can help slow the spread of Coronavirus COVID-19 in under 60 seconds. USA TODAY

Even before the first horrific phase of the COVID-19 pandemic has run its course, scientists are worried aboutthe second wave of the disease.

It could crashworse than the first, killing tens of thousands of people who did such a good job of sheltering in place they remain virgin ground for the virus. Or it could be a mere swell, with so many people having been infected without symptoms that levels of immunity are higher than realized.

There is no crystal ball to look to, because so many crucial pieces of information remainmissing.

Are people who've had COVID-19immune? How long does immunity last? Will the virus play out likeinfluenza and the common cold, peaking during cooler months and fallingduring warmer ones? Is itsdeadly path undeterred whatever the weather?

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Until theres a vaccine its unfortunately not unlikely that we may see a second wave or even a third wave, said Peter Marks, director of the U.S. Food and Drug Administrations Center for Biologics Evaluation and Research, which oversees vaccines.

I shudder to think of that, but I think we have to be realistic."

Health care worker Ludnie Emile prepares to test patients for COVID-19 at a drive-thru coronavirus testing station in Palm Springs, Fla. on March 19.(Photo: Greg Lovett, The Palm Beach Post/ USA TODAY Network)

The first question on every doctors mind is whether someone who hashad COVID-19 is immune, and if sofor how long. People who've had mumpsare immune from it for life. Versions of the common coldcaused by different types of coronavirus seeimmunity wanewithin a year. Variations are wide.

COVID-19 is such a new disease that there is no solid dataon the immunity of survivors. But given its similarities to coronaviruses such as severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), it's expected to conveyat least some immunity.

Thats good news because so many people have contracted COVID-19 from SARS-CoV-2, the virus that causes the disease. Many moreprobably have had it asymptomatically and didnt know. Both groups likely have some immunity.

A class war? A global power shift?How experts see the future after coronavirus.

What percentage of the population is immuneis impossible to know because the United States doesnt yet have widespread testing, experts say. An answer is likely months away. Even if immunity isn'tlifelong, the virus may have infected enough people to make it hardfor it to find new victims.

It would mean wed be getting to herd immunity through natural immunity even before a vaccine is developed, said Marc Lipsitch, a professor of epidemiology at Harvards Chan School of Public Health, whoco-wrote a paper in the journal Science modelingwhat COVID-19 might look like after the initial pandemic has passed.

When itcomes back, its likely to hit hardest areas not severely infected the first time, said Gregory Poland, a professor of medicine at the Mayo Clinic in Rochester, Minnesota, and editor-in-chief of the journal Vaccine.

This outbreak has predominantly been on the two coasts. Wave 2 will be in the interior of the county where there are a lot of susceptible people, he said.

America has suffered great loss before.Here's how we may learn to cope with coronavirus death toll.

Another factor is whetherthe virus survives longer in cooler, drier weather. Thatswhy the flu is more common in winter, its virus survives longer and people are more likely to be indoors in close contact.

We have no idea really whether this is going to bounce back the moment people start going back outdoors or if the warmer weather is actually going to help us out, said Michael Mina, a professor of epidemiology at the Center for Communicable Disease Dynamics at Harvard's Chan School of Public Health.

If it doesnthappen in the summer, wed all be very surprised if we dont see some reemergence in the fall, he said.

Fact check: Sunlight does not kill the new coronavirus

In that case, COVID-19s sweet spotcould be the same as influenza, roughly October to May, with a peak between October and November, modeling suggests. If it does behave like influenza, it will move to the Southern hemisphere for winter there, then return to the Northern hemisphere for its cold months.

To anthropomorphize, the virus will come back here looking for new victims, Poland said.

The first wave of the disease, which the world isexperiencingnow, hit so hard because no one had immunity. It could eventually fall into a pattern ofyearly reoccurrence, like influenza.

If compounded with the annual wave of winter flu, the nations hospitals would be further taxed.

A fall spike also seems likely as children go back to school, said Mike Reid, a professor of infectious disease at the University of California-San Francisco.

To preventthat, wide-scale testing will need to be available, and contact tracing must be in place tofind everyone who hasbeen exposed and get them to self-isolate for at least 14 days.

Given the potential for repeated waves, the more that can be put in place to rapidly jump on every new spike and ring-fence every infected individual with wraparound health services is going to be crucial, Reid said.

When will life return to normal?Expert says US testing is too far behind to know

Experts say how we behave will play a large part in the size and severity ofsubsequent waves. People can help by remaining vigilant about washing their hands, continuingto socially distance and wear masks in public.

Add to that more surveillance andwidely available tests, chances improvethe second waveis smaller than the first.

As states begin to ease restrictions, theUnited States will effectively become a massive series of experiments.Epidemiologists will be watching carefully, Lipsitch said.

Some areas will reopen schools, while otherwill have staggered school days, so not all students are thereat the same time. The same will happen inworkplaces,even as more workfrom home. Some areas will cocoon the elderly, taking special care they are not exposed. Others may create passports for people who are immune, if there's data showing infectionconfers immunity.

There are many things we can do, and we dont know how any of them will work yet, Lipsitch said.

Doing temperature testing in schools and businesses,as is now done in Asia, could be helpful.

Its not the most sensitive test in the world, but it is a screen that keeps people conscious that they have an obligation not to infect other people, said Barry Bloom, a professor of public health at Harvards Chan School of Public Health.

Staying Apart, Together: This newsletter will help you cope with the coronavirus pandemic

Vigilance will be key, experts say.

No one can say when the coast is clear, said William Hanage, a professor of epidemiology at Harvards Chan School of Public Health.

COVID-19 is easy enough to spread and has a long enough incubation period its possible to go from 100 known cases one week to 65,000 a few weeks later. One slip and we couldsee it resurging, he said.

Theres a cautionary tale from the 2003 outbreak of SARS in Toronto, which infected 375 people there and killed44. The city tookexpanded precautions beginning in March, but they were lifted in Maywhen it appeared theoutbreak was over. It wasnt.

Toronto took the brakes off," Hanage said. "Theyhad a flare, and it took them weeks to get it back under control.

Contact reporter Elizabeth Weise at eweise@usatoday.com

The former leader of the Global Rapid Response Team at the Centers for Disease Control and Prevention on Friday explained what we know about the COVID-19 pandemic. (April 10) AP Domestic

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When will a second wave of the coronavirus hit, and what will it look like? - USA TODAY

Covid-19 has made fundamental and long-lasting changes to the way we live our lives, not just in the UK, but across the world.

As we continue with social-distancing measures and deal with the most immediate issue of reducing the number of cases to protect the NHS and save lives, and keeping R, which is the average infection rate per person, below one, we also need to progress ways to tackle the disease in the longer term.

Ultimately the way out will likely include vaccines, new medicines or both. An effective vaccine would both prevent people getting Covid-19 and curb transmission.

The vaccines taskforce will be working in lockstep with the public and private sector

Ideally, we would have one ready to take off the shelf and roll out yesterday. One that could be delivered at scale. But this is a new disease that didnt exist before December and we have a lot to learn about the virus and how the body responds to it.

All new vaccines that come into development are long shots; only some end up being successful, and the whole process requires experimentation. Coronavirus will be no different and presents new challenges for vaccine development. This will take time, and we should be clear it is not a certainty.

But there is cause for optimism. With more than 80 vaccine projects across the world, there is an effort the like of which has never been seen before.

A vaccine has to work, but it also has to be safe. If a vaccine is to be given to billions of people, many of whom may be at a low risk from Covid-19, it must have a good safety profile.

Even when a vaccine has been shown to produce an immune response there will still be clinical testing and trials to be done. With Covid-19 we need to understand more about the immune response and how that will alter the response to the disease. This presents new challenges for making an effective and safe vaccine.

Simultaneously, if we are to respond at the right pace, work must and will be taking place to build the manufacturing capacity needed to take any vaccine from lab to jab; producing the millions or potentially billions of doses that will be needed if an effective vaccine is found. This sort of scaling of a vaccine can be done but is not a trivial task.

The UK is home to world-leading scientists, researchers and companies who are at the forefront of vaccine development and manufacturing. The progress in vaccine developments from our academic institutions here in the UK is impressive. And as the announcement from GSK and Sanofi shows, companies are collaborating to work together to tackle this threat.

Helping get a vaccine is rightly one of the governments biggest priorities, which is why we have brought together scientists, industry leaders and the government under a single taskforce. This will ensure vaccine discovery is funded, clinical trials can be done quickly, regulators help speed the path to a safe and effective vaccine, and we develop manufacturing capabilities to ensure that we can make and access large quantities of vaccine.

Co-operation between the UK and international efforts has to be at the heart of this, and the UK is funding vaccines development through partnership across the world.

The more vaccine development projects there are, the greater the odds that a vaccine will be available in 12-18 months. But it is not certain.

In the UK there is already a lot of work, with pre-clinical studies underway at the University of Oxford and Imperial College London to name but two. And the UK is a major international donor to the programme to develop a coronavirus vaccine under the Coalition for Epidemic Preparedness Innovations, pledging 250m.

The vaccines taskforce will be working in lockstep with the public and private sector, supporting leading academics and identifying ways to fast-track clinical trials.

The UK has a proud history in vaccinology. It was an Englishman, Edward Jenner, who pioneered the field over 200 years ago. Two centuries on, the scientific community will work tirelessly to find a medicine or vaccine against Covid-19, and we need to back them every step of the way.

Patrick Vallance is the UK government chief scientific adviser

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There are reasons to be optimistic about a coronavirus vaccine. But it will take time - The Guardian

About a month ago, Medical News Today started a series aiming to bring together the more encouraging research that emerges around COVID-19. We continue with this Special Feature that focuses on an incoming vaccine and other potential treatments for this new coronavirus and the disease it causes.

With this series, we aim to remind our readers that while COVID-19 causes great sorrow and loss around the world, the resulting global emergency has also meant that scientists are working at an unprecedented pace. They are making progress that is easy to overlook among the worrying numbers of new cases and deaths.

Two recent MNT articles COVID-19: 5 reasons to be cautiously hopeful and COVID-19: Physical distancing, drug trials offer hope looked at the latest developments in potential treatments, vaccines, and the outcomes of infection control measures during the pandemic.

We continue our series with this third Special Feature, which continues to monitor progress in the areas mentioned above.

Stay informed with live updates on the current COVID-19 outbreak and visit our coronavirus hub for more advice on prevention and treatment.

We focus on a vaccine that some researchers believe may be available by the fall and round up expert opinions on this promising development. We also cover an app-based social tracing system that could help create intelligent physical distancing instead of national lockdowns.

We previously reported that the World Health Organization (WHO) have launched a global megatrial that involves testing four potential treatments for COVID-19. Remdesivir, initially developed to treat Ebola, was one of those four potential treatments.

Now, scientists from the University of Alberta in Edmonton, Canada, say that remdesivir is showing promise in in vitro experiments.

The same team had previously demonstrated that remdesivir effectively combatted another coronavirus, MERS-CoV. It did so by blocking polymerases, which are enzymes that allow the virus to replicate.

Study co-author Prof. Matthias Gtte explains, If you target the polymerase, the virus cannot spread, so its a very logical target for treatment.

He continues to report the results of the teams new experiments: We obtained almost identical results as we reported previously with MERS, so we see that remdesivir is a very potent inhibitor for coronavirus polymerases.

Prof. Gtte goes on to explain, These coronavirus polymerases are sloppy, and they get fooled, so the inhibitor gets incorporated many times, and the virus can no longer replicate.

Still, the author cautions, Weve got to be patient and wait for the results of the randomized clinical trials.

Another hopeful finding comes from researchers from Cornell University in Ithaca, NY. These scientists also started their research efforts by drawing parallels with other coronaviruses, such as SARS-CoV and MERS-CoV.

Namely, they looked at the spike protein that coronaviruses have and zoomed in further on the fusion peptides these are short-chain amino acids that the spike proteins contain.

Whats really interesting about SARS-CoV and MERS-CoV, and this new virus, SARS-CoV-2, is this particular part of the protein, the fusion peptide, is almost exactly the same in those three viruses, explains study co-author Prof. Susan Daniel.

The new study found that calcium ions enable fusion peptides to help coronaviruses penetrate healthy cells through a process called membrane fusion. This offers a potential target for a new antiviral treatment.

The team has already secured funding to start developing an antibody that could stop this process by targeting SARS-CoV-2s fusion peptide.

Blocking the fusion step is significant because the fusion machinery doesnt evolve and change as fast as other parts of the protein do. Its been built to do a particular thing, which is to merge these two membranes together. So if you can develop antiviral strategies to reduce that efficiency, you could have potentially very broadly-acting treatments.

Prof. Susan Daniel

Sarah Gilbert, a professor of vaccinology at Oxford Universitys Jenner Institute in the United Kingdom, and her team may soon be closing in on a vaccine for SARS-CoV-2.

The approach uses a harmless chimpanzee virus to carry the fragment of SARS-CoV-2 that is required for immunity, explains Ian Jones, Professor of virology at the University of Reading, U.K.

Colin Butter, an associate professor of bioveterinary science at the University of Lincoln in the UK, explains: Professor Gilberts team [] have made a recombinant vaccine against the SARS-CoV-2 virus by taking a virus that is entirely harmless to humans, the Chimp Adenovirus designated ChAdOx1, and inserting into it the spike protein gene from the [new] coronavirus.

Prof. Gilbert believes that the vaccine will be available for general use by the fall, which could prevent a potential second wave of the new coronavirus.

That is just about possible if everything goes perfectly, Prof. Gilbert told The Times in an interview. The researchers are set to put the new vaccine into human trials in the next 2 weeks.

The researcher explains that during the pandemic, scientists can fast-track the process through which the vaccine reaches the population by doing many of the necessary steps in parallel.

First, there is the need to manufacture the vaccine for clinical studies under tightly controlled conditions, certified and qualified we need ethical approval and regulatory approval. Then, the clinical trial can start with 500 people in phase I.

This is always in healthy adults aged about 18 to 55, and usually the primary read-out from a phase 1 study is safety, Prof. Gilbert explains. Then we can do phase 2, looking at a wider age range; in this case, we are going to increase the age range, 55 to 70 plus. We are looking at safety in the older age group, [and] we expect to see weaker immune responses.

The researcher explains that she and her team plan to spread their studies across different countries so that they can reduce the time it takes to test the vaccine.

[I]ts vital we go fast before a high proportion [of the population] become infected. But it also means we are going to need to do studies in different countries because the amount of virus transmission is affected by the lockdowns.

The vaccine could get approval under emergency use legislation, meaning that in an emergency situation, if the regulators agree, its possible to use a vaccine earlier than in normal circumstances, Prof. Gilbert adds.

It is worth noting that other experts have expressed concern over Prof. Gilberts estimates.

Prof. David Salisbury, for example, says, [I]t is not just the availability of the first dose that we need to focus on. We need to know by when there will be sufficient doses to protect all of the at-risk population, probably with two doses, and that means industrial-scale manufacturing that governments do not have.

The approach in itself, however, is viable, and the research group benefits from a lot of credibility in the scientific community. The approach has been extensively tested in other situations, so there is indeed a good chance it will work as designed, says Prof. Jones.

The [research] group has a long history of success in this area, adds Dr. Butter. On the basis of this prior experience, it would be reasonable to assume that the vaccine would induce antibody and cellular immune responses, both of which may be important in controlling the virus in an individual.

Any final roll-out will almost certainly need a level of manufacturing the [U.K.] does not readily have, so transfer to and liaison with an external manufacturer may also need to be tackled. But the roadmap is clear, lets hope they get there.

Prof. Ian Jones

Tissue plasminogen activator (tPA) is a drug designed and approved to prevent blood clots in people who have had a stroke, pulmonary embolism, or heart attack.

Now, a new trial to test its benefits for relieving acute respiratory distress syndrome (ARDS) in people with COVID-19 is underway.

TPA acts as an anticoagulant. This means it prevents blood clotting by breaking down fibrin. Fibrin can form plugs in the airways and contributes to small clots in the blood vessels of the lungs.

In patients with COVID-19, these small microfibrin plugs in the air sacs lead to ARDS. As a result, these patients require ventilators to be able to breathe.

Were hearing anecdotally that a subset of patients with COVID-19-induced ARDS are clotting abnormally around their catheters and [intravenous] lines, explains Dr. Michael B. Yaffe, Ph.D., an acute care surgeon at the Beth Israel Deaconess Medical Center (BIDMC) in Boston, MA.

Dr. Yaffe is also the senior author of the study that proposed repurposing tPA to treat COVID-19 complications.

We suspect these patients with aggressive clotting will show the most benefit from tPA treatment, and this new clinical trial will reveal whether thats the case, says Dr. Yaffe.

The scientists have started to recruit some of the COVID-19 patients admitted to the BIDMC for the trial. The team also hopes to find biomarkers that can help identify patients who are most likely to benefit from the treatment.

If effective and safe for the treatment of ARDS in patients with COVID-19, tPA could save lives by reducing recovery time and freeing up more ventilators for other patients in need.

Christopher D. Barrett, clinical trial investigator

Another finding that may help relieve the pressure on public health systems is a mobile app-based contact tracing system.

The authors of the new project explain that such a system could help reduce the rate at which the virus spreads while also mitigating some harmful effects of a full national lockdown.

Dr. David Bonsall senior researcher at Oxford Universitys Nuffield Department of Medicine, clinician at Oxfords John Radcliffe Hospital both in the UK, and co-lead of the project explains how the system works.

He says, The mobile app concept weve mathematically modeled is simple and doesnt need to track your location. It uses a low energy version of Bluetooth to log a memory of all the app users with whom you have come into close proximity over the last few days.

If you then [contract the virus], these people are alerted instantly and anonymously and advised to go home and self-isolate. If app users decide to share additional data, they could support health services to identify trends and target interventions to reach those most in need.

The findings could pave the way for intelligent [physical] distancing, avoiding the social and economic effects of full lockdowns.

For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here.

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COVID-19: Vaccine may be ready by fall and other reasons for hope - Medical News Today