Category: Covid-19 Vaccine

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told ... [+] JAMA's editor Thursday, July 2, that the safety and effectiveness of a Covid-19 vaccine should be known by early winter with 200 hundred million doses available for U.S. use by early 2021. In this photo, Fauci speaks during a Senate Health, Education, Labor and Pensions Committee hearing on June 30, 2020 in Washington, DC. (Photo by Al Drago - Pool/Getty Images)

Dr. Anthony Fauci said the safety and effectiveness of a vaccine for the coronavirus strain Covid-19 should be known by early winter with 200 hundred million doses available for U.S. use by early 2021.

In an interview Thursday with the editor of JAMA, Fauci said several Phase 3 trials testing experimental Covid-19 vaccines in tens of thousands of patients are beginning later this month and into August across the U.S. Among them are candidate vaccines being developed by Moderna and AstraZeneca.

We may be able to at least know whether we are dealing with a safe and effective vaccine by the early winter, late winter, beginning of 2021, Fauci, who is the director of the National Institute of Allergy and Infectious Diseases, told Dr. Howard Bauchner, editor of JAMA, during the interview, which was live Thursday afternoon.

Multiple (vaccine) candidates are at different stages of development, Fauci said. We are hopeful that one or more of them may actually show a good degree of safety. . . and efficacy.

Several of the manufacturers are already producing the vaccines at risk thanks to the help of U.S. taxpayer dollars. Fauci wouldnt name the companies making the vaccines, but said these manufacturers are promising that they will have a couple a hundred of million doses as we go into the early part of 2021.

After a year, (vaccine manufacturers are) saying they likely could get a billion doses, Fauci said.

The update on vaccine development from Fauci came a day after the U.S. reported nearly 50,000 new cases of Covid-19 on Wednesday as the pandemic worsens, particularly in the South and West.

Last month, Fauci told JAMAs Bauchner that a trial of Modernas candidate vaccine will include primarily U.S. sites, but also include international sites enrolling 30,000 individuals in a randomized placebo controlled trial of Modernas vaccine against the Coronavirus strain Covid-19. Modernas vaccine candidate is considered in the lead among several efforts by drug and vaccine makers in the battle against the deadly virus.

On Thursday, Fauci said several of the vaccines heading into the final stage of clinical trials are going to be similar in their effectiveness and these phase 3 trials will be ramping up from July through September.

Because there are several late-stage trials, Fauci is optimistic a successful vaccine will emerge by the end of the year. And the U.S. should benefit.

When you have two or three companies which you hope will be successful, they are going to be making vaccine not only for their own country, but availability in other countries, Fauci said.

There is this misperception that everybody is racing to be the winner, Fauci said. Theres not going to be a winner. Hopefully, more than one of them will be successful.

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Fauci: Covid-19 Vaccine Safety And Effectiveness Should Be Known By Early Winter - Forbes

A 30,000-patient trial of Modernas coronavirus vaccine candidate, expected to start next week, has been delayed, a potential hurdle in the companys ambitious effort to deliver key data by Thanksgiving.

Moderna is making changes to the trial plan, called a protocol, which has pushed back the expected start date of the Phase 3 study, according to investigators. The investigators, who spoke on condition of anonymity, emphasized that protocol changes are common but said its not clear how long the start will be delayed.

My understanding was that they wanted to get the first vaccines given in July, and they say theyre still committed to do that, one investigator said. As best I can tell, theyre close to being on target for that.

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Investigators at the University of Illinois at Chicago had previously said Modernas trial would begin July 9. On Thursday, NIH Director Francis Collins also told lawmakers in Washington that the study would begin this month.

Moderna did not respond to multiple emails asking about how long the delay will last, the nature of the protocol changes, or whether they have anything to do with the vaccines safety or manufacturing. After publication, CEO Stphane Bancel told CNBC that Moderna still intends to start the trial in July. In a statement posted to Twitter on Thursday afternoon, the company said it has worked closely with the National Institutes of Health, which is funding the Phase 3 study, to align the final protocol in order to begin the trial on time.

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The intense focus on the exact timing of the trial stems from the tight nature of the race to develop a vaccine for the novel coronavirus and the fact that any delay could imperil Modernas pole position. Pfizer, working with the German firm BioNTech, plans to start a 30,000-patient study of its own later this month. AstraZeneca and Oxford University are slated to begin a similarly sized trial in August, followed by Johnson & Johnson in September.

All of the companies are working at unprecedented speed to advance their vaccines, and Moderna may not be the last to see its timeline delayed.

Developing and manufacturing vaccines at scale is always a challenging endeavor, with unexpected hitches the norm rather than the exception. Candidate vaccines that looked promising in animals can fail to deliver the same results in people. Production problems arise.

During the 2009 H1N1 flu pandemic, U.S. officials confidently predicted there would be a vaccine in the early autumn, in time to fend off an expected second wave of infections. But the new virus grew poorly in eggs, the substrate used in influenza vaccine production. By the time mass amounts of vaccines were ready for distribution, the peak of infection in the country had already passed.

Matthew Herper and Helen Branswell contributed reporting.

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Moderna Covid-19 vaccine trial delayed, but July start still possible - STAT

Global markets are on the rise Thursday on news of a potential effective vaccine for the novel coronavirus.

European markets are continuing to make gains in mid-morning trading the FTSE in London is up 0.8%, Pariss CAC-40 index is up 1.4%, and the DAX index in Frankfurt is 1.6% higher.

Asian markets posted a clean sweep of gains to begin the trading day. Japans benchmark Nikkei index finished 0.1% higher, while the Hang Seng in Hong Kong earned 2.7% and the Shanghai Composite closed 2.1% higher.

Australias S&P/ASX index was 1.6% higher, the KOSPI index in South Korea closed up 1.3%, and Taiwans TSEC index rose 0.8%. The Sensex in Mumbai is up 1.2% in late afternoon trading.

Investors were optimistic after U.S. pharmaceutical giant Pfizer and Germanys BioNtech said preliminary data from early-stage human trials of a new vaccine showed promise.

Oil markets are also trading well Thursday. U.S. crude is selling at $40.05 per barrel, up 0.5%, while Brent crude, the global benchmark, is selling at $42.29 per barrel, up 0.6%.

All three U.S. indexes are trending positively in futures trading ahead of Thursdays announcement of the latest U.S. unemployment figures.

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Global Markets Enjoy Boost on Promising News of COVID-19 Vaccine - Voice of America

When the World Health Organization (WHO) says that a given anti-coronavirus product is a leader, that's about as official as it gets in the fast-moving world of COVID-19 therapies and vaccines.

Earlier this year, a top WHO executive stated that Gilead Sciences' remdesivir was the leading therapy targeting COVID-19. Remdesivir, of course, has now become the de facto standard of care for the novel coronavirus disease.

Last week, WHO chief scientist Soumya Swaminathan stated in a news conference that one experimental COVID-19 vaccine appears to be "probably the leading candidate." Which vaccine is it?

Image source: Getty Images.

Swaminathan thinks that the COVID-19 vaccine being developed by AstraZeneca (NYSE:AZN) and the University of Oxford should be viewed as the top contender right now. There are two main reasons why.

First, the AstraZeneca-Oxford AZD1222 vaccine is already in a phase 3 clinical study. No other COVID-19 vaccine candidates have yet advanced to late-stage testing. Swaminathan specifically noted "how advanced they are" and "the stage at which they are" in naming the vaccine being developed by AstraZeneca and Oxford as the likely leader.

Second, Swaminathan said that she thinks "AstraZeneca certainly has a more global scope at the moment in terms of where they are doing and planning their vaccine trials." The late-stage testing of AZD1222 will be conducted in several countries, with trials already in progress in the United Kingdom, Brazil, and South Africa.

The vaccine candidate was originally developed by the University of Oxford's Jenner Institute. AstraZeneca teamed up with Oxford in April and owns the rights to distribute the COVID-19 vaccine globally. AZD1222 was one of only a handful of novel coronavirus vaccines selected by the Trump administration to receive federal funds as part of Operation Warp Speed, an initiative to rapidly develop a safe and effective COVID-19 vaccine.

Another COVID-19 vaccine is a close No. 2, according to the WHO chief scientist. Swaminathan views Moderna (NASDAQ:MRNA) as "not far behind" AstraZeneca and the University of Oxford in the race to develop a COVID-19 vaccine.

Moderna's messenger RNA (mRNA) COVID-19 vaccine mRNA-1273 is currently in phase 2 clinical testing. The biotech plans to begin a phase 3 study of the vaccine in July. Like AZD1222, Moderna's mRNA-1273 was included in the select group of COVID-19 vaccine candidates that are receiving federal funding in the Operation Warp Speed program.

Stephane Bancel, Moderna's CEO, is optimistic about the chances of success. He said in a CNBC interview recently that he believes that the probability of mRNA-1273 going on to win approval from the U.S. Food and Drug Administration is between 80% and 90%.

Investors should be wary of banking on AstraZeneca to emerge as the winner in the COVID-19 vaccine race just because it's the apparent leader right now. Nearly 150 COVID-19 vaccine candidates are currently being researched. Seventeen of those are in clinical trials, with more on the way.

It's impossible to know which, if any, of these experimental vaccines will be successful. It's not out of the question -- and perhaps even likely -- that multiple drugmakers will eventually win regulatory approvals for their COVID-19 vaccines.

The biggest winners from an investing perspective could very well be the small biotech stocks in the race. Novavax, for example, has a phase 1/2 clinical study underway for its COVID-19 vaccine candidate. BioNTech, like Moderna, is testing an mRNA COVID-19 vaccine with its partner, Pfizer.

AstraZeneca claims a market cap of nearly $70 billion. Success for its COVID-19 vaccine would definitely be a major catalyst for the stock. But success for a small drugmaker like Novavax or BioNTech would almost certainly be transformational for either company.

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Here's the "Official" Leader in the COVID-19 Vaccine Race - Motley Fool

The news: An experimental covid-19 vaccine being developed by Pfizer and BioNTech provoked immune responses in 45 healthy volunteers, according to a preprint paper on medRXiv. The levels of antibodies were up to 2.8 times the level of those found in patients who have recovered. The study randomly assigned 45 people to get either one of three doses of the vaccine or a placebo. But there were side effects like fatigue, headache, and feverespecially at higher doses. The researchers decided to discontinue with the highest dose, 100 micrograms, after the first round of treatments.

Some caveats required: Its promising news,but this is the first clinical data on this specific vaccine, and it hasnt been through the process of peer review yet. Higher antibody levels in patients whod received the vaccine are a useful proxy for immunity to covid-19, but we dont yet know for sure that they guarantee immunity. In order to find out, Pfizer will start conducting studies in larger groups of patients, starting this summer. It says its goal is to have 100 million doses of a vaccine available by the end of 2020.

A common approach: Pfizer is using the same experimental technique as Moderna, one of the other pharmaceutical companies developing a vaccine. Both vaccines are designed to provoke an immune response against the coronavirus through its messenger RNA, the genetic instructions that tell the virus how to replicate inside the host. The method could provide a rapid way to develop a vaccine, but its yet to lead to a licensed one for sale. Currently, 178 vaccines are in various stages of development; 17 are now going through clinical trials.

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Another experimental covid-19 vaccine has shown promising early results - MIT Technology Review

The biohacker who injected himself with CRISPR is back. This time, hes setting out to solve a problem at the forefront of everyones mindthe need for a COVID-19 vaccineand he thinks he can beat biopharma to it.

Nevermind that companies like Moderna and AstraZeneca are racing vaccine candidates into and through the clinic at a speed never seen before, and the U.S. government has set up a Manhattan Project-style initiative aptly dubbed Operation Warp Speed, which aims to deliver 100 million doses of a viable COVID-19 vaccine by the end of the year. Thats still too slow for Josiah Zayner.

This is the perfect opportunity for biohackers, Zayner told Bloomberg. We can move science faster.

De-risking the Development of Biotherapeutics Using Early Stage In Vitro Expression and Genetic Characterisation Tools

There is a high attrition rate during the development of biotherapeutics impacting the high cost of development. Early identification of the preferred expression host for manufacturing, along with lead candidate screening and material supply can help to reduce both attrition rates and cost.

RELATED: COVID-19 vaccine leaders talk up the need for partners, potential for a working vax by October

His plan is based off a Science paper published in May showing that a DNA vaccine seemed to provoke an immune response against SARS-CoV-2, the virus that causes COVID-19. The researchers developed multiple vaccines expressing different forms of the virus spike protein and tested them in monkeys.

RELATED: After Operation Warp Speed picks 5 finalists, experts question why some vaccines were left out

Along with collaborators in Mississippi and Ukraine, Zayner wants to reproduce that experiment in humansthemselvesand livestream the process over several weeks, Bloomberg reported.

They said specifically what they used, which is really easy to recreate, Zayner told Bloomberg, speaking from the West Oakland, California, headquarters and lab of his company, The Odin. You know, it works in monkeys. Let's test it on humans.

RELATED: Pfizer, Merck, AZ, J&J and Moderna selected as 'Warp Speed' finalists: NYT

The scheme, dubbed Project McAfee, after the antivirus software, is possible thanks to the availability of new tools and technologiesincluding viral DNAto the general public. Zayner ordered the same spike protein the researchers used in their DNA vaccine from a DNA synthesis company, having it put in a solution that could be injected into his muscles, Bloomberg reported.

RELATED: Biopharma's no-holds-barred fight to find a COVID-19 vaccine: The full list

Zayner and his partners plan to inject themselves with the vaccine and then take antibody tests regularly to see if their bodies mount an immune response, Bloomberg reported.

Zayner and David Ishee, one of his partners and a self-taught scientist in Mississippi, think the project could pierce the veil on biotech research and scientific experiments.

I want people to learn something from this, he said, So it's no longer this big black box of what science, clinical trials and all this stuff is, Zayner told Bloomberg.

I would like to see a future where biotech is less arcane, Ishee said. But the most realistic thing that will come of this is that maybe people will understand the news theyre reading better.

But Hank Greely, a bioethicist at Stanford University, said the approach has its limits.

If he has and uses the appropriate biosafety precautions, I see nothing wrong with his efforts to replicate the macaque work in living human cells, Greely told Bloomberg. If he can do that, it might be a somewhat useful scientific finding.

The keywords are living human cells. Compare that to the massive clinical trials underway, or soon to be, for vaccines from Moderna, AstraZeneca, Pfizer and BioNTech. Earlier this month, Moderna finalized the design for a 30,000-patient phase 3 study, while AstraZeneca and the University of Oxford have already started a phase 2/3 study involving more than 10,000 people.

At best hell have three people who have received this DNA vaccine, he said.Its hard for me to see his administration of a vaccine to three people as producing any useful scientific knowledge, except perhaps in the unhappy result that they have terrible reactions to it. But even then, its just anecdotal, a caution but not a proof.

And thats not allZayner may pull off his experiment, but copycats may not.

Even if he does it well, people copying him poorly could be hurt. And for what? Greely said. Uncontrolled experiments with doubtful, non-standardized ingredients and conditions are not likely to lead to scientific knowledge that will produce vaccines faster.

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DIY vaccine maker aims to beat pharma to a COVID-19 shotand he'll start by injecting himself - FierceBiotech

Factually is a newsletter about fact-checking and accountability journalism, from Poynters International Fact-Checking Network & the American Press Institutes Accountability Project. Sign up here

Last month, FactCheck.org debunked a meme, still floating around on Facebook, that had a couple of made-up quotes attributed to the U.S. governments top infectious disease official. It was called The two faces of Dr. Anthony Fauci.

The first quote falsely had him saying that even though hundreds of doctors have cured people with the drug hydroxychloroquine, it still needs to be studied some more. The other face of Fauci had him saying this: As soon as a COVID-19 vaccine is manufactured, it must be delivered to healthcare professionals for immediate human injection. Proper studies can be done later. Fauci never said that either.

The meme was a triple play on anti-vaccine emotions anger that government officials are hypocrites, fear that they are trampling on individual liberties with the diktat that the vaccine must be deliveredfor human injection, and distrust in the government to implement proper safety studies.

Its this kind of emotional manipulation that scientists like Fauci are up against. The New York Times Kevin Roose recently called it the vaccine information war.

The anti-vaxxers, Roose wrote, are savvy media manipulators, effective communicators and experienced at exploiting the weaknesses of social media platforms.

But if government health officials are outgunned in this conflict, at least they are now acknowledging it. They have indicated in recent days that they are forming their messaging for when a COVID-19 vaccine is ready, perhaps late this year or early in 2021.

At a Senate hearing Tuesday, Fauci and other public health officials said the government would be putting boots on the ground in community engagement efforts to ensure that people understand the importance of getting the COVID-19 vaccine once its developed and shown to be safe.

There are similar issues in Canada, where a vaccine expert at the University of Toronto told the CBC that the public health community was facing a major, major challenge given how early the anti-vaxxers have geared up their campaigns. And in Africa, an early trial was marked by a worrying level of resistance, the Associated Press reported.

The stakes are high. If not enough people get the vaccine, populations will not reach the herd immunity needed to halt the spread of the virus.

Getting there will involve careful messaging. While Faucis been wildly popular among people who like his focus on facts and science (there are positive Fauci memes, too, and even Fauci cupcakes and candles) he thinks he might not be the best messenger for everybody.

They may not like a government person in a suit like me telling them, even though I will tell them, Fauci told CNN this week. They really need to see people that they can relate to in the community sports figures, community heroes, people that they look up to.

That is especially true if the government person in a suit is also portrayed in a manipulative meme that falsely quotes him. People will get confused about which quotes are real and which arent. Which, of course, is the point.

Susan Benkelman, API

A hoax circulating in Spain falsely alleged that COVID-19 is mainly spread by contaminated flu vaccines. The claim further asserts the flu vaccine contains portions of other viruses such as HIV and herpes, and advocates the public should pass on the flu naturally saying the vaccine will only weaken ones immune system.

Spanish fact-checking organization Agencia EFE pointed out the genetic differences between the flu and the novel coronavirus, and pointed to European Union quality controls to reaffirm the safety of vaccines. EFE also noted that most flu vaccines were administered in September and October, but Spains spike of COVID-19 patients occurred several months later.

What we liked:

This fact-check helps readers distinguish between COVID-19 and seasonal flu. It also serves as a warning for fact-checkers and members of the public that this kind of misinformation could become more prevalent as we get closer to a COVID-19 vaccine.

Harrison Mantas, IFCN

Thats it for this week! Feel free to send feedback and suggestions to factually@poynter.org. And if this newsletter was forwarded to you, or if youre reading it on the web, you can subscribe here. Thanks for reading.

Susan and Harrison

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Government officials are readying for battle against COVID-19 vaccine misinformation - Poynter

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The international race for a Covid-19 vaccine is on. Who will win? - HealthLeaders Media

COVID-19 vaccine trials are well under way, but Bill Gates is not optimistic that phase III of these trials, which measures the efficacy and safety of a vaccine in a wide group of users, will be successful before the end of the year.

Gates spoke about the work toward a COVID-19 vaccine and how the coronavirus pandemic will continue to shape our future in a TED2020 live conversation with Chris Anderson on Monday. When asked about where we are in the quest for a vaccine, Gates mentioned three companies thatif they workare on track to have vaccines the earliest: Moderna, Johnson & Johnson, and AstraZeneca.

Those three will be gated by the safety and efficacy trial, he says. That is, well be able to manufacture thosealthough not as much as we wantbefore the end of the year. Whether the phase III will succeed, and whether it will be complete before the end of the year, I wouldnt be that optimistic about.

This echoes what leaders in the health tech industry think, according to a recent 300-person survey. Even though at least 90 vaccine candidates for COVID-19 are in development, seven of which had advanced to phase I trials by April, only 31% of the experts surveyed thought a vaccine would be broadly available by 2021.

Chinese officials did just approve a COVID-19 vaccine for use in its military, but the Chinese government is skipping phase III trials for this vaccine. Studies so far have shown this vaccine is safe and has some efficacy, according to Reuters, but phase III trials are a more robust consideration of a vaccines effects.

How helpful a vaccine is to curbing this pandemic still depends, ultimately, on how many people get the vaccine. Gates says that like mask wearing, vaccines have a huge community benefit. Getting a vaccine and wearing a mask are important to protect your community from the novel coronavirus, not only yourself.

In the U.S., mask wearing has become a point of political contention rather than something unilaterally adopted by the public as part of a collective effort to curb the viruss spread. Some have held onto the fact that the World Health Organization (WHO) initially did not advise people to wear masks. When asked if that was a terrible mistake the organization made, Gates replied, Yes.

The fact that the medical mask was a different supply chain than the normal mask, the fact that you could scale up the normal mask so well, the fact that it would stop that presymptomatic and never-symptomatic transmission, he says. Its a mistake, but its not a conspiracy. Its something that we now know more. And even now, our error bars on the benefit of masks are higher than wed like to admit, but its a significant benefit.

Looking forward to fall, Gates does not expect the COVID-19 pandemic to wane in the U.S., especially without widespread mask wearing, vaccines, or other drugs or innovative tools. While there is good progress on such tools, he says, theres nothing that would fundamentally alter the fact that this fall in the United States could be quite bad, and thats worse than I would have expected a month ago.

The degree to which shelter-in-place behavior has lapsed, the amount of people not wearing masks, and the presence of COVID-19 in cities it had not been in previously pose a challenge for the upcoming months.

Theres no case where we get much below the current death rate, which is about 500 deaths a day, but theres a significant risk we go back up to the even 2,000 a day that we had before because we dont have the distancing, the behavior change to the degree that we had in April and May, he says. We know this virus is somewhat seasonal, so that the force of infectionthrough temperature, humidity, more time indoorswill be worse as we get into the fall.

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Bill Gates says he's 'not optimistic' COVID-19 vaccines will successfully complete trials before end of the year - Fast Company

Dr. Scott Gottlieb offered hope over the weekend for those worried over the coronavirus pandemic and the need for a vaccine.

Gottlieb said the U.S. and the world will likely see a successful vaccine in early 2021. Thats almost more than six months away.

In the meantime, Gottlieb said there are two things that can help stop the spread right now. One of those is a mask. Wearing a mask can help protect you and others from spreading the coronavirus pandemic.

But Gottlieb said theres hope for something coming in the fall that could help Americans.

2020 will be a hard year but then well more fully vanquish COVID with our technology. It will recede into a more manageable threat. Preserving things most central to our lives requires all of us to work together to reduce risks every day. Collectively we can stop these epidemics

A vaccine is probably an early 2021 event based on publicly available data. But dont lose sight of therapeutic antibodies. They should be available this fall and could be produced at scale by the end of the year. Theres a lot of technology in development in addition to vaccines.

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Coronavirus: When will there be a COVID-19 vaccine? Therapeutic might come first - Deseret News