Category: Covid-19 Vaccine

Welcome to theFiercePharmapolitical roundup, where each Monday well highlight developments in Washington, D.C., and elsewherethat could affect drug pricing and how drugmakers operate.

About sixmonths into the pandemic and about 130 days until the U.S. presidential election, COVID-19 vaccines are moving ahead at record speeds. Now, a group of analysts predicts at least one vaccine will be approved before November 3.

Jefferies healthcare strategist Jared HolztoldMarketWatch that perhaps multiple vaccines could get FDA authorizationsearly in the fourth quarter and quell fears of a second wave of COVID-19.

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The teamcited severalreasons why an approval, or emergency use authorization, may come before the November election. For one, Trump could push the FDA behind the scenes toissue an approval or emergency authorization. Moderna and AstraZeneca, two vaccine front-runners, have already told the analysts an approval could happen on that timeline, according to the report.

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

Meanwhile, a vaccine approval mightliftthe entire industry,rather thanjust one or two companies,Holz told the publication.Ifthe industrydelivers a successful shot,itdbe seen as saving the day amidthe pandemic, and that would lift sentiment around all of biopharma. With that lift, thered be less political pressure to take on drug pricing.

The analysts at Jefferies arent the only market watcherswho believe vaccines could be approved before the election.In a New York Timesop-edearlier this month, University of Pennsylvania professorsEzekiel Emanuel and Paul Offitwarned about a possible October surprise in the form of a COVID-19 vaccine approval on political grounds.

FDA commissioner Stephen Hahn, though, said his agency wont be pressured to approve a shot for politicalreasons. HetoldThe Guardian that science and datanot politicshas and will always guide our decision-making, including our work related to vaccines.

Several vaccines, including thosefrom Moderna and AstraZeneca, are slated forlate-stagetests this summer, The Wall Street Journal has reported. Worldwide, about 140 COVID-19 vaccines are in development, and 13 are in human testing, according to the World Health Organization.

RELATED:Moderna, AstraZeneca and J&J coronavirus shots rev up for NIH tests beginning in July: WSJ

Meanwhile,on the subject of drugpricing regulations, several companiesscored a winlast weekagainst the U.S. Department of Health and Human Services (HHS) when aU.S. appeals court found that the bodydoesnt have the authority to compeldrugmakersto include prices in TV ads.

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FiercePharmaPoliticsFDA could approve 'at least one' COVID-19 vaccine before election: analyst - FiercePharma

Dr. Anthony Fauci said it's a question of 'when, not if' the United States will have a vaccine for COVID-19.

WASHINGTON The next few weeks are critical to tamping down a disturbing coronavirus surge, Dr. Anthony Fauci told Congress on Tuesday issuing a plea for people to avoid crowds and wear masks just hours before mask-shunning President Donald Trump was set to hold a campaign rally in one hot spot.

Fauci and other top health officials also said they have not been asked to slow down virus testing, in contrast to Trumps claim last weekend that he had ordered fewer tests be performed because they were uncovering too many infections. Trump said earlier Tuesday that he wasn't kidding when he made that remark.

We will be doing more testing, Fauci, infectious disease chief at the National Institutes of Health, pledged to a House committee conducting oversight of the Trump administration's response to the pandemic.

The leading public health officials spent more than five hours testifying before the committee at a fraught moment, with coronavirus cases rising in about half the states and political polarization competing for attention with public health recommendations.

Fauci told lawmakers he understands the pent-up desire to get back to normal as the U.S. begins emerging from months of stay-at-home orders and business shutdowns. But that has to be a gradual step-by-step process and not throwing caution to the wind, he said.

Plan A, dont go in a crowd. Plan B, if you do, make sure you wear a mask, Fauci said.

Troubling surges worsened Tuesday in several states, with Arizona, Texas and Nevada setting single-day records for new coronavirus cases, and some governors saying theyll consider reinstating restrictions or delaying plans to ease up in order to help slow the spread of the virus.

Arizona, where Trump was headed for a rally at a Phoenix megachurch, reported a new daily record of nearly 3,600 additional coronavirus infections Tuesday. Arizona emerged as a COVID-19 hot spot after Republican Gov. Doug Ducey lifted his stay-home orders in mid-May. Last week he allowed cities and counties to require masks in public places and many have done so.

Texas surpassed 5,000 new cases for a single day for the first time just days after it eclipsed 4,000 new cases for the first time as Americas largest pediatric hospital began taking adult patients to free up bed space in Houston. The infection rate in Texas has doubled since late May. And Nevada surpassed a record one-day increase for the fourth time in the past eight days. Other states also were experiencing worrisome surges, including Louisiana, Utah and South Carolina.

Last week, Vice President Mike Pence published an opinion article in The Wall Street Journal saying the administration's efforts have strengthened the nation's ability to counter the virus and should be a cause for celebration.

Another worrisome trend: an increase in infections among young adults. Fauci said while COVID-19 tends to be less severe in younger people, some of them do get very sick and even die. And younger people also may be more likely to show no symptoms yet still spread the virus.

If people say, Im young, Im healthy, who cares you should care, not only for yourself but for the impact you might have on sickening someone more vulnerable, Fauci said.

About 2.3 million Americans have been infected and some 120,000 have died, according to data from Johns Hopkins University.

Republican Rep. David McKinley of West Virginia asked if Fauci regretted that the American public wasnt urged sooner to wear face masks, and then interrupted before the visibly annoyed scientist finished answering.

Fauci said he didnt regret the change in recommendations. Early in the pandemic there was a paucity of equipment for health workers who put themselves daily in harms way and we did not want to divert those scarce supplies, he said.

Scientists eventually recommended the general public use cloth masks, after they better understood that people with no symptoms could be spreading the virus even though they don't offer as much protection as the sophisticated masks reserved for health workers and aren't a substitute for staying 6 feet away from other people.

Trump, meanwhile, doubled down on testing claims that have public health experts appalled, tweeting Tuesday:

Cases are going up in the U.S. because we are testing far more than any other country, and ever expanding. With smaller testing we would show fewer cases!

Less testing in fact means more infections going undetected. The U.S. was slow in ramping up and currently is testing about 500,000 people a day. Many experts say to control the spread of the virus, it should be testing 900,000 or more.

Brett Giroir, a Health and Human Services assistant secretary, told lawmakers Tuesday the next step is testing patient samples in large batches to stretch limited supplies, which would expand U.S. screening between fivefold and tenfold.

Instead of testing each person individually, health workers would pool samples from 50, 100 or more people from the same office or school, for example. A negative result would clear everyone, while a positive would require each person to be individually re-tested.

And Dr. Robert Redfield, head of the Centers for Disease Control and Prevention, added that its now required for workers in nursing homes hard-hit by the virus to be tested weekly.

As for the anxiously awaited vaccine, Fauci said he believes it will be when and not if it arrives, and hes cautiously optimistic that some vaccine could be available at the end of the year.

More than a dozen vaccine candidates are in various stages of testing around the globe, and the U.S. next month is poised to begin the largest study in 30,000 people to get the needed proof that one really works. Meanwhile, countries, including the U.S. under a program called Operation Warp Speed, have begun stockpiling millions of doses of different shots, in hopes at least some will prove usable.

Health officials assured lawmakers Tuesday that there wont be shortcuts on safety.

We absolutely must maintain regulatory independence and make the right decision for the American people based on the science and the data, said Food and Drug Administration Commissioner Stephen Hahn.

Democrats blasted Trump for confusing the public with erroneous statements from testing to masks to unproven treatments and ignoring the public health experts advice.

It costs lives, Rep. Kathy Castor of Florida said of Trumps false claims. She urged the public health specialists to do more to counter the president: We really expect you to be more outspoken.

Pushed on whether schools should reopen in August and September, Redfield insisted that will vary not just by state but by school district, depending on how many infections are in a particular area.

Many jurisdictions will be reopening schools, and CDC will soon issue some guidelines to help, he said.

Fauci noted that schools should tailor their decisions to local conditions, saying some might need few restrictions and others more. He offered the same advice to colleges, saying they should assume some students will get infected and that there must be ways to keep them and their classmates safe.

Read more:

Fauci hopeful for COVID-19 vaccine by end of the year or early 2021 - 9News.com KUSA

Many of us are well-aware of the everyday tactics of battling the coronavirus: wearing masks, washing our hands and staying six feet apart from others. But what are the recent developments in the medical world in terms of treatment or prevention?

Health experts and economists report the United States may not return to life before COVID-19 until a vaccine is widely available. While The New York Times reports more than 140 potential vaccines are in development, none have yet to be approved for use.

Dr. Charlie Monteiro serves on the board of the Durham-Orange County Medical Society and is the former president of the North Carolina Medical Society. In a recent interview with 97.9 The Hills Aaron Keck, Monteiro said the development process is moving very quickly compared to normal and said he thinks its going better than expected.

Vaccine development or any new drug or treatment development has to go through various phases to determine whether it works and is safe, Monteiro said. Then, it gets compared to whatever the standard treatment is to determine if its acceptable to be approved. The vaccine research is getting into the third phase and thats the last phase before it gets approved. Thats very exciting.

One popular option discussed in the absence of a vaccine has been developing antibodies, which happens when someone recovers from COVID-19 and their body has developed a way to combat it. Monteiro said there have been some cases where a serum is made with a persons antibodies to treat severely ill coronavirus patients. But he said he thinks the methods of either administering or everyone naturally developing antibodies to the coronavirus are unlikely to be what solves the pandemic.

The antibody test has been a disappointment, from my experience, said Monteiro. Ive tested a number of patients who were proven positive and Ive only had one come back positive with antibodies. That patient had been severely ill and hospitalized. I think the false negative rate for the antibody test is very high and, unfortunately, not good enough.

In the meantime, Monteiro said strides have been made regarding drug treatment for patients who have the coronavirus. For the most severe cases, he said a drug developed at UNC has seen success.

Theres an antiviral drug called remdesivir, said Monteiro, which has demonstrated to be beneficial for very severely ill patients who are in the intensive care unit. [When a patients] oxygen levels are below 94 percent oxygen saturation, those are the indicators to use [remdesivir] and its been demonstrated to be helpful.

Monteiro also said recently-published research from the United Kingdom showed progress with using an anti-inflammatory steroid to combat COVID-19.

We found out that dexamethasone, a very inexpensive, powerful oral or IV steroid, has been effective in treating very sick patients, he described.

Whenever a vaccine ultimately comes out, theres likely to be challenges making it widely available.

Who does Monteiro think it should go to first?

I think along the front lines for those who are most at-risk he said, and of course all of our frontline workers who have [already] been exposed. I think its going to be [given] there first, for sure.

For daily updates of COVID-19 cases in Orange and Chatham Counties, as well as across North Carolina, visit Chapelboros coronavirus tracker web page.

Photo viaAP Photo/Brian Inganga.

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COVID-19 Vaccines and Treatment Progressing, But Long Way from Widely Available - Chapelboro.com

The Case For Using Novel Value Elements When Assessing COVID-19 Vaccines And Therapeutics  Health Affairs

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The Case For Using Novel Value Elements When Assessing COVID-19 Vaccines And Therapeutics - Health Affairs

Nigerian scientists claim to have discovered COVID-19 vaccine  |  Photo Credit: iStock Images

Ede, Osun: A team of Nigerian scientists claimed to have discovered a unique vaccine that may help prevent the novel coronavirus infection, according to local media. The discovery of the vaccine was announced on Friday by Nigerian Universities Scientists, under the aegis of COVID-19 Research Group, even as researchers all over the world race against time to find a cure for the SARS-CoV-2 virus, which has so far killed at least 465,300 people globally.

Dr Oladipo Kolawole, a specialist in Medical Virology, Immunology and Bioinformatics, at Adeleke University, Ede in Osun, and leader of the research team, said during a news conference that the vaccine was being developed locally in Africa for Africans, reported The Guardian Nigeria. According to Kolawole, the unnamed vaccine, when unveiled, would also work for other races.

Kolawole, however, said that it would take a minimum of 18 months before the vaccine would become available to the public for widespread use since a lot of analysis and trials as well as approvals by medical authorities were required.

Kolawole said the research initially received funding - roughly 7.8 million Nigerian nairas ($20,000) - from the Trinity Immunodeficient Laboratory and Helix Biogen Consult, Ogbomosho. He further added that the team had been working extensively by exploring the genome of the SARS-CoV-2 virus from samples across Africa to select the best potential vaccine candidates.

He added that the researchers had been able to pick the best potential COVID-19 vaccine candidates and had made the possible latent constructs after trying out some selected processes of vaccine development.

Meanwhile, Prof Solomon Adebola, the Acting Vice-Chancellor of the university, said the university was poised to assist in the funding of the research with a view to bringing the vaccine to the limelight, the report added.

We are glad that a vaccine that will provide a solution to a global problem like coronavirus pandemic is coming from the garden. It is our passion to be a solution provider to such a global pandemic, and we are ready to throw our weights behind the team and make the vaccine a reality, Adebola said.

Furthermore, prof Julius Oloke, the Head, Coordinating Unit of the Research Group and Vice-Chancellor of Precious Cornerstone University, Ibadan, said the vaccine was real.

The vaccine is real. We have validated it several times. It is targeted at Africans, but will also work for other races. It will work. It cannot be faked. This is a result of the determination. It took a lot of scientific efforts. The population of those that need vaccines is more than those that need drugs. That is why the research focussed on a vaccine, he was quoted as saying by the report.

As per the World Health Organization (WHO), at least 13 experimental COVID-19 vaccines are currently being tested in humans and more than 120 candidates are in earlier stages of development.

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Nigerian scientists claim to have discovered COVID-19 vaccine - Times Now

Israeli government research institute says tests of its COVID-19 vaccine have worked on hamsters - Jewish Telegraphic Agency Skip to content{{{ data.lastUpdate }}}{{{ data.sponsorTemplate }}}

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Israeli government research institute says tests of its COVID-19 vaccine have worked on hamsters - Jewish Telegraphic Agency

Stphane Bancel, CEO of Moderna Therapeutics

Source: Moderna Therapeutics

Recent history suggests a new vaccine entering human clinical trials has about a 1-in-3 chance of getting FDA approval. Stephane Bancel, chief executive ofModerna, pegs the chances of his company's novel coronavirus vaccine at closer to 80% to 90%.

"We know our platform," Bancel said in a recent interview. "It works on MERS, Zika and CMV and so on. When you have the right sequence ... you will get neutralizing antibodies."

Moderna, the apparent front-runner in the Covid-19 vaccine race, has shown its vaccine elicits those neutralizing antibodies (so-called because they stop the virus from being able to infect cells) in early human studies but in just eight people so far.

Still, Bancel's expectations are high. The company has announced plans to start a 30,000-person efficacy trial in July, the first planned in the U.S. It's enrolled more than half of its mid-stage study of 600 people already. All before the complete data from the first stage of the trials has been fully reported, and as the company just posted results of the vaccine's testing in mice. (They showed "promising signs of efficacy," William Blair analysts wrote, "albeit in mice.")

So how did a 10-year-old company with no products yet on the market leapfrog industry giants like Johnson & Johnson and Merck in one of the greatest medical races in history?Moderna was No. 1 on CNBC's Disruptor 50 list in 2015, and five years later it's still disrupting.

If you ask Bancel, there are precisely five reasons.

First, the technology: messenger RNA. It's a way to deliver genetic instructions to the body's cells to make proteins. For the SARS-CoV-2 vaccine, called mRNA-1273, the instructions encode for the virus' spike protein (the protrusions that give the coronavirus family its name, meaning "crown"). Once the body's cells read the instructions and make the protein, the goal is that the immune system will mount a response that would be protective if the vaccinee encounters the virus in the wild.

It's an elegant idea, and it's also very speedy. Moderna delivered the first doses of vaccine to its partners at the National Institute of Allergy and Infectious Diseases in just 42 days.

We know our platform. It works on MERS, Zika and CMV and so on. When you have the right sequence ... you will get neutralizing antibodies.

Stephane Bancel

CEO, Moderna

Bancel's second reason: This is the tenth vaccine Moderna has brought into human clinical trials. The company's most advanced, before the unprecedented timeline set by its Covid-19 program, is a vaccine against CMV, or cytomegalovirus.

Third: Moderna's previous work on MERS, or Middle East Respiratory Syndrome, caused by a virus in the same coronavirus family as SARS-CoV-2. While that vaccine didn't enter human trials, it was a previous collaboration with the National Institutes of Health that Bancel credits for creating the foundation that enabled the early partnership on Covid-19.

Fourth and fifth: Moderna has its own manufacturing plant, in Norwood, Massachusetts, which is "fully digital," employing machines to avoid human error, and "fully integrated," Bancel explained, "meaning we make our critical raw material. We make the mRNA; we formulate it in the lipids."

"If we had had contract manufacturers," he said, "we might still be in preclinical as we speak." (Preclinical is the stage before human trials.)

Perhaps a sixth reason is Bancel himself, and his talent for establishing relationships with the right people.

Two years ago that meant an outreach to Dr. Anthony Fauci and his team at NIAID, which led to the nation's infectious diseases agency and the company working together on a vaccine for MERS, which sickened almost 2,500 people in outbreaks since September 2012and killed about a third of them.

Last fall, Bancel said, the groups agreed to do a trial run of a new outbreak scenario, planned for the second quarter of 2020. But before they could, they were faced with the real thing. Chinese researchers posted the sequence of SARS-CoV-2 online Jan. 11. Two days later Moderna and the NIAID had agreed on the design of their vaccine.

That mRNA-1273 is now approaching a 30,000-person phase 3 trial, six months after it was created, is unheard of. And it's not the only one: An AstraZeneca/Oxford University vaccine is expected to start a similar study in August, while J&J pegs September for its start date for a large efficacy trial.

NIAID's Fauci calls the goal of having a vaccine ready to deploy by the end of the year "aspirational, but it's certainly doable."

Still, there are many questions to be answered. The vaccines have to be proved safe and they have to work.

Bancel joins Fauci in pledging that risks being taken are only business risks, not safety ones.

"Neither us nor NIAID nor FDA was willing to take a safety risk," Bancel said. "What we've taken is business risk, and we've taken a lot of business risk."

Moderna started making the doses for phase 2 trials even as participants were getting the first doses in phase 1, he said.

To be sure, Moderna's financial risk was blunted somewhat by an award from the Biomedical Advanced Research and Development Authority, or BARDA, of $483 million. But the company indicated it would need more funding to finish the job (and drew criticism for a stock offering to raise more funds that was timed after a 20% spike in its share price following the preliminary phase 1 data release).

Any business risk Moderna's been willing to take has been because it's a pandemic, Bancel said, but also because the vaccine "has a high chance of working."

He couches his prediction of an 80% to 90% probability of success to the likelihood the vaccine will have efficacy of above 50% meaning it can reduce the risk of disease by half.

More from Disruptor 50:Meet the 2020 CNBC Disruptor 50 companiesThe technology that will dominate daily life on the other side of coronavirusBono-backed Beautycounter is moving in to Sephora, bringing its clean makeup to the masses

"At the public health level, a vaccine with 50% [efficacy] will slow down drastically infections," Bancel said. He said he'd need more data to assess the probability of the vaccine showing 90% efficacy.

Meanwhile, as the vaccine moves through clinical testing, Moderna is preparing for the prospect of its first product receiving regulatory approval, hiring Amgen's former chief financial officer David Meline and former Amgen communications head Ray Jordan, and seeking a head of commercial and legal policy to guide the Covid-19 vaccine to market.

It's also signed a deal with manufacturer Lonza to make 500 million to 1 billion doses of the vaccine each year. But don't count out Moderna's Norwood manufacturing facility, which Bancel still wants to show off but only with the proper precautions.

"Once you get the Moderna vaccine," he told me, "you have an open invitation."

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Moderna CEO sees 'high probability' of success with Covid ...

FARMINGDALE, N.Y.,June 18, 2020/PRNewswire/ Codagenix, Inc., a clinical-stage biotechnology company developing prophylactic vaccines and oncolytic virus therapies, today announced the successful synthesis of a readily-scalable live-attenuated vaccine candidate against COVID-19. The vaccine, CDX-005, is currently undergoing safety and efficacy studies in animals and appears markedly attenuated compared to wild-type SARS-CoV-2, the virus that causes COVID-19, with pre-clinical data expected by early July.

Codagenix, backed by investors Adjuvant Capital and TopSpin Partners, is collaborating with the Serum Institute ofIndiato develop CDX-005. Although there are more than 140 COVID-19 vaccine candidates currently under development, CDX-005 is one of only a handful of live-attenuated approaches to tackling the current pandemiceven though this framework has led to some of historys most successful vaccines, such as those for measles, smallpox, and rubella. Codagenix is bringing this proven technology into the 21st century with its powerful deoptimization algorithms, allowing the company to engineer vaccine candidates that are structurally identical to naturally circulating SARS-CoV-2 at the amino acid level, yet are unable to efficiently replicate in the vaccine recipient. The goal of this approach is to stimulate a robust immune response that mimics that of the wild-type virus, without leading to clinical illness or further transmission. Codagenix scientists believe that, to the extent natural SARS-CoV-2 infection protects an individual from reinfection for a given period of time, CDX-005 has promising potential to do the same.

Equally important, CDX-005 grows to robust concentrations in cell culture, allowing its production to be scaled rapidly using fairly common vaccine manufacturing equipment to meet the vast, global demand. This is another distinguishing factor relative to the crowded landscape of other COVID-19 vaccines in development, such as those using mRNA, virus-like particles, or adenovirus-vectors, which in many cases may require specialized production infrastructure and/or comparably large quantities of antigen per person to be effective. The anticipated immunogenicity of CDX-005, in contrast, may require only modest quantities of active ingredient per person to be effective, potentially allowing the production of hundreds of millions of doses per year or more from existing vaccine facilities.

Following the successful completion of pre-clinical animal studies, CDX-005 will be manufactured by the Serum Institute and tested in a Phase I clinical trial slated to begin in the fall of 2020. Serum Institute will simultaneously scale manufacturing for large-scale safety and efficacy studies, in addition to preparations necessary to meet global vaccine supply requirements.

There are currently no licensed vaccines available against COVID-19. Until an effective vaccine becomes available, transmission of the virus can be prevented by frequent handwashing, social distancing, and wearing a face covering when in contact with others.

About Codagenix

Codagenix is a clinical-stage synthetic biology company that uses software to recode the genomes of viruses, constructing live-attenuated vaccines or viruses to prevent viral infections or treat solid tumors. Codagenixs recoded vaccine candidates are a perfect antigenic match to the target virus and induce a robust immune response to all viral antigens. For cancer, our nimble platform allows us to turn a virus into a potential oncolytic immuno-oncology therapy. Both programs rely on scalable, low-cost manufacturing. Codagenix Inc. spun out of the laboratory of National Academy of Science Member Eckard Wimmer atStony BrookUniversity in 2012 and is located at the Broad Hollow Bioscience Research Park inFarmingdale, N.Y.Our programs are supported by Adjuvant Capital, TopSpin Partners, Euclidean Capital, and government agencies such as the USDA, NIH/NIAID and the Department of Defense.

For more information, visitwww.codagenix.com.

About Adjuvant Capital

Adjuvant is aNew York andSan Francisco-based life sciences fund built to accelerate the development of new technologies for the worlds most pressing public health challenges. Backed by leading healthcare investors such as Merck, Novartis, and the Bill & Melinda Gates Foundation, Adjuvant draws upon its global network of scientists, public health experts, biopharmaceutical industry veterans, and development finance professionals to identify new investment opportunities. Adjuvant invests in companies developing promising new vaccines, therapeutics, diagnostics, and medical devices for historically overlooked indications such as malaria, cholera, Lassa fever and postpartum hemorrhage, with a commitment to make these interventions accessible to those who need them most in low- and middle-income countries.

For more information, visitwww.adjuvantcapital.com.

About Serum Institute ofIndia

Serum Institute of India Pvt. Ltd. is the worlds largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses) which includes Polio vaccine as well as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps, and Rubella vaccines. It is estimated that about 65% of the children in the world receive at least one vaccine manufactured by Serum Institute. Serum Institute ofIndiawas founded in 1966 by Dr.Cyrus Poonawallawith the aim of manufacturing life-saving immuno-biologicals, which were in shortage in the country and imported at high prices. Thereafter, several life-saving biologicals were manufactured at prices affordable to the common man and in abundance, with the result that the country was made self-sufficient for Tetanus Anti-toxin and Anti-snake Venom serum, followed by DTP (Diphtheria, Tetanus and Pertussis) group of Vaccines and then later on MMR (Measles, Mumps and Rubella) group of vaccines. The Philanthropic philosophy of the company has proliferated to bring down the prices of newer vaccines such as Hepatitis-B vaccine, Combination vaccine etc., so that not onlyIndias, but the entire under-privileged children of the world are protected from birth onwards.

SOURCE Codagenix, Inc.

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Codagenix Announces the Synthesis and Preliminary Safety of Scalable, Live-attenuated Vaccine Candidate Against COVID-19 - SynBioBeta

The average times of the fastest sprinters in the 100-metre dash are in the ballpark of 10 seconds. So, what would you think if someone promised to run the race in one second?

It typically takes a minimum of 10 years for a vaccine to complete the three consecutive phases of the clinical research pipeline. This is because of the scope and length of the experiments, the need to critically assess the results at each stage and the mountains of paperwork that are involved.

READ MORE: WHO says its hoping for a vaccine this year

What are the chances that this can be reduced to 12 months? Indeed, it has been implied that this process can be accelerated to warp speed.

We contend that a safe and effective vaccine against severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), which is the causative agent of coronavirus disease COVID-19, most likely cannot be made available to the public in time to make a substantial difference to the natural outcome of this pandemic. People often cling to hope even when prospects of success are low. However, this can have negative consequences if that hope is not realized.

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We are academic scientists who manage vaccine research programs. In fact, one of us Byram Bridle, received COVID-19-focused funding to develop a novel vaccine platform.

Although many of us are working hard toward developing vaccines against SARS-CoV-2, we worry that some in the scientific community have offered too much hope for this to be accomplished in a timely fashion. Sometimes these promises are used by politicians and governments to inform public policies. As a result, the integrity of the scientific community is now in the limelight and, arguably, at risk.

Vaccines are an effective way for a population to achieve what is known as herd immunity. This is the concept that the pandemic will end once approximately 60-70 per cent of people become immune to SARS-CoV-2. An alternative is to let SARS-CoV-2 run its natural course until herd immunity is achieved. With physical distancing, some epidemiologists argue this could take two years, during which time a vaccine could be developed.

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However, vaccinating at the tail end of a pandemic when disease incidence is very low and declining may be of little utility, hence the race to develop a vaccine for COVID-19. If one is not in widespread use within the first half of 2021, it will probably be too late to have a meaningful impact on the control of COVID-19.

[ Sign up for our Health IQ newsletter for the latest coronavirus updates ]

Educators often rely on past performance to predict the future performance of students. In this respect, how was the performance of the scientific community in the wake of the original SARS-CoV, or Middle East respiratory syndrome (MERS)-CoV? The fact is, no vaccine against a coronavirus has successfully navigated the rigours of clinical testing, despite having up to 17 years to do so.

The same applies to other dangerous respiratory pathogens, such as respiratory syncytial virus. Whether enough has been learned from these past experiences to get the design of COVID-19 vaccines right remains to be seen, and still does not negate the need for a rigorous testing process that will take time.

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One concern is that some vaccines can protect against disease (that is, the outcome of an infection) but not against infection (the ability of the virus to get into the body). In this scenario, vaccinated individuals could potentially become asymptomatic carriers of SARS-CoV-2, thereby spreading COVID-19. For this and many other reasons, a cautious approach must be taken to developing COVID-19 vaccines.

READ MORE: What we know and dont know about asymptomatic coronavirus transmission

What about the fact that there are front-runner vaccines already in human clinical trials?

First, many of the vaccine technologies that can most readily make it to the front of the line are not necessarily the best quality. The easiest way to make a vaccine is to inactivate the pathogen or use pieces of it, and mix them with an adjuvant, which tells the immune system that the pathogen is dangerous and worth responding to.

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However, an inactivated virus or its components do not behave like the live virus, so the immune system sometimes responds to these vaccines in a way that is ineffective or sometimes even dangerous. For example, no vaccine based on the genetic material, known as ribonucleic acid or RNA, from a virus like SARS-CoV-2 has ever been approved. Further, some vaccines developed against the original SARS-CoV, after the epidemic was over, exacerbated the disease in mice.

READ MORE: As rich nations prepare for coronavirus vaccine, others could be left behind, experts say

A vaccine for COVID-19 does not have to be the best one, but it does need to be good enough to accelerate a populations progression to herd immunity. As experienced peer reviewers, we have some concerns about the rigour of some of the science surrounding COVID-19 vaccines.

Some vaccines are fast-tracking through the regulatory system before studies are completed and with minimal details of experimental results being released. Executives of a big pharmaceutical company whose vaccine is among those closest to the finish line recently sold their stocks after releasing positive results that were superficial, partial and that included three of eight healthy young volunteers experiencing severe adverse events.

Events like this are causing the public to become skeptical. A promising vaccine should have solid data to back it up. Those touting vaccines against COVID-19 that are in clinical trials should be asked to provide comprehensive details and results of their study. This enables objective and rigorous evaluations by the broader scientific community. A lack of complete transparency would be cause for concern.

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Assuming a vaccine succeeds in human trials, it then needs to be manufactured in massive quantities at an affordable price, undergo quality control testing and be distributed worldwide. Even if by some miracle this spectrum could be bridged at warp speed, one then needs to wonder if up to 70 per cent of individuals can be effectively vaccinated.

Uptake of a vaccine could be compromised by anti-vaxxers, as well as by perceptions that warp-speed manoeuvring might be the result of cutting too many corners and compromising safety. Then there are those who simply do not respond as well to vaccines, which includes the elderly who are in the greatest need of protection.

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Considering what we now know about SARS-CoV-2 vaccines, we need to take a more cautious approach and one could question if any of the vaccines that are now in pre-clinical testing can possibly help with the current pandemic. We sincerely hope that our pessimism about vaccines currently in clinical trials being ready in time is soundly proven wrong.

Even if a vaccine doesnt get developed in time, not all is lost.

The array of vaccines being engineered will help with outbreaks beyond COVID-19. They can be vetted by scientists and the best technologies and associated research teams could be shortlisted to be called upon for future outbreaks.

Although clinical research likely cannot be shortened to 12 months while maintaining integrity of the science, the current attempt to do so will build new and reasonable efficiencies into health regulatory policies. This will facilitate getting a wide variety of future health solutions to patients faster, but not at warp speed.

Byram W. Bridle, Associate Professor of Viral Immunology, Department of Pathobiology, University of Guelph and Shayan Sharif, Professor of Immunology and Associate Dean, Research and Graduate Studies, University of Guelph

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This article is republished from The Conversation under a Creative Commons license. Read the original article.

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COMMENTARY: Think a COVID-19 vaccine is months away? It could actually take years - Global News

Since the onset of the coronavirus outbreak, a vaccine has been widely regarded as the best path toward reopening society and returning to normalcy. Scientists have worked around-the-clock to develop a vaccine even entering late-stage human studies at record speed for the disease that has killed more than 430,000 people worldwide.

Yet, despite these Herculean efforts, scientists say a one-time cure-all is unlikely. Data on close cousins of the COVID-19 virus, including seasonal coronaviruses that cause the common cold, suggests the COVID-19 vaccine probably won't offer lifelong protection -- although more research is needed to understand how well and for how long a potential vaccine could work.

It's a problem significant enough to worry Dr. Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, who has been excited at the chance of developing a vaccine, but hesitant to predict how long it might work.

"When you look at the history of coronaviruses, the common coronaviruses that cause the common cold, the reports in the literature are that the durability of immunity that is protective ranges from three to six months to almost always less than a year," Dr. Fauci said in an interview with JAMA Editor Howard Bauchner.

"That's not a lot of durability and protection," Fauci said.

And although it's too soon to say how long a COVID-19 vaccine might protect you, an executive at AstraZeneca, one of the companies working to develop an effective vaccine, told a radio station that he thinks his vaccine might only offer protection for one year.

This means that if we get a safe and effective COVID-19 vaccine, it might not offer lifelong protection. Vaccine experts told ABC News it's still too early to know for sure.

A health worker process for COVID-19 antibodies after getting the blood from the patient at the the Diagnostic and Wellness Center, May 5, 2020, in Torrance, Calif.

As scientists race to answer some of these questions, the United States government is forging ahead with Operation Warp Speed, an ambitious plan to have enough doses of a safe and effective vaccine to be able to vaccinate the majority of Americans by 2021.

"We cannot promise 100% chance of success," a senior government official told reporters earlier this week. "What we can tell Americans is that we've taken every possible step to maximize the probability of success and shorten the timelines to getting safe, effective vaccines and therapeutics."

One way to gauge the durability of an eventual vaccine could be to look at people who have already been infected with and survived COVID-19. But even though some people with COVID-19 have demonstrated an immune response to the disease and recovered, the longevity of response is still unknown, since scientists and doctors have known about the virus for less than six months.

Still, early studies have found that the immune response to SARS-CoV-2, the virus that causes COVID-19, is probably similar to SARS-CoV and MERS-CoV. And we know from SARS and MERS that immunity can last a few years, but antibody protection tends to wane about a year post-infection. This means that even people who have recovered from COVID-19 could get it again in the future.

Nevertheless, a COVID-19 vaccine could induce long-lasting immunity even if the infection does not, said Dr. Paul Goepfert, director of the University of Alabama at Birmingham Vaccine Research Clinic.

"Because vaccines are much more focused in their immune response, it could be that you could develop an antibody to the part of the virus that is more long-lasting," Dr. Goepfert said.

It may come down to the structure and biology of this particular virus. SARS-CoV-2, the virus that causes COVID-19, is covered in tiny spikes called surface proteins. Experts say that the virus is unlikely to mutate in a meaningful way, meaning the vaccines that are being developed now are likely to work in the future.

Different vaccine developers are taking different approaches to create a COVID-19 vaccine. Some groups, such as Oxford and its partner AstraZeneca, are using a traditional approach of using the virus itself but neutering it so that it doesn't make people sick.

Others, such as Moderna and Pfizer, are hoping that by coaxing the body to create this protein, they might be able to trick the immune system into mounting an effective response against future infection. They're hopeful that their approach will allow them to be more agile should the virus mutate in the future.

Aside from durability, not all vaccines have complete protection, for example, the annual flu shot ranges in effectiveness and works better for children than for the rest of the population. In 2019, it was less than 50% effective in preventing the flu, but there were still major benefits.

"A 60% effective COVID vaccine would still decrease the number of infections, the number of deaths and the number of people who become severely ill," Goepfert said.

"Obviously, a vaccine that works 100% of the time would be ideal, but that is not realistic," said Dr. John Mascola, director of the National Institutes of Health Vaccine Research Center.

It's possible that, like the flu vaccine, an eventual coronavirus vaccine might also work better for certain groups, although right now experts say it's too soon to tell.

Should scientists develop a safe and effective vaccine -- and they are cautiously optimistic that they will -- it would be the safest approach to achieving herd immunity. Epidemiologists estimate that about 60% to 80% of the U.S. population would have to recover from COVID-19 or have the antibodies from a vaccine to stop the virus from spreading widely.

The reality is that a coronavirus vaccine may provide relatively short protection, said Dr. Beth Kirkpatrick, chair of the University of Vermont's Department of Microbiology and Molecular Genetics.

Researchers may have to consider booster shots or revaccination if people's antibodies fall below the amount associated with protection -- a count that is still unknown. Only time will tell, and long-term observation of patients after vaccination will determine how durable the vaccine really is.

"We will have to follow those people for quite a long period of time to be able to know how long it's going to last for, because if it starts fading away, it won't be until a year or two years or three years that we'll start seeing the infections pop up in people that got vaccinated," Kirkpatrick said.

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What will a COVID-19 vaccine look like? Dont expect a cure-all, scientists say - ABC News