Category: Covid-19 Vaccine

The US government's top infectious disease expert is warning against the fast-tracked approval of a COVID-19 vaccine, saying that doing so "prematurely" could actually set back efforts to immunize the population against the novel coronavirus.

In an interview with Reuters, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said that the "one thing you would not want to see with a vaccine is getting an EUA [emergency use authorization] before you have a signal of efficacy."

The warning comes a day after the US Food & Drug Administration issued an EUA for COVID-19 plasma therapy under political pressure from the White House, with President Donald Trump himself claiming that the "deep state" was thwarting efforts to treat and prevent the spread of the coronavirus, an apparent reference to normal clinical trials for new medicines and vaccines.

The Financial Times reported Monday that the Trump administration is considering "bypassing normal US regulatory standards" and issuing an EUA, ahead of the 2020 election, for an experimental vaccine being developed by AstraZeneca and Oxford University. That vaccine has yet to advance to large-scale clinical trials.

Such a move would mirror efforts by Russian President Vladimir Putin, who announced the release of a COVID-19 vaccine after less than two months of testing on fewer than 100 people.

A Trump administration spokesperson denied the report.

Speaking to Reuters, Fauci urged caution.

"One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their [clinical] trial," he said.

Public health experts have warned that an ineffective or dangerous vaccine, released before it has been fully vetted, could enflame the anti-vaccination movement and prolong the spread of the coronavirus.

"To me, it's absolutely paramount that you definitively show that a vaccine is safe and effective, both," Fauci said. "We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective."

Have a news tip? Email this reporter: cdavis@insider.com

Read more:

Fauci warns against rushed approval of COVID-19 vaccine - Business Insider - Business Insider

Covid-19 vaccine trial at Brigham and Women's criticized for lack of diversity  Boston Business Journal

See the article here:

Covid-19 vaccine trial at Brigham and Women's criticized for lack of diversity - Boston Business Journal

Stocks rose Monday, with the S&P 500 and Nasdaq hitting fresh highs and adding to last weeks record levels, as market participants reacted to positive developments over a coronavirus treatment, and signs that a vaccine might be authorized in the near-term. The Dow closed above 28,000 for the first time since February, led by advances in shares of Boeing (BA) and Dow Inc. (DOW).

[Click here to read whats moving markets heading into Tuesday, August 25]

Travel, airline and other reopening stocks rallied, with shares of American Airlines (AAL), Norwegian Cruise Line Holdings (NCLH), Wynn Resorts (WYNN) and their peers each jumping. Apple (AAPL) shares advanced to their highest intraday level ever ahead of the stocks four-for-one stock split.

The U.S. Food and Drug Administration (FDA) on Sunday said it issued an emergency use authorization for investigational convalescent plasma to treat Covid-19 in hospitalized patients. While the treatment has not yet undergone full clinical trials, the FDA said that it deemed that the data so far suggest product may be effective in treating Covid-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.

President Donald Trump, speaking in a press conference, called the approval a very historic breakthrough, and said the treatment reduced mortality by 35%, based on a study of patients by the Mayo Clinic.

Meanwhile, the Trump administration is also reportedly considering fast-tracking a U.K. coronavirus vaccine candidate by bypassing typical U.S. regulatory standards, the Financial Times reported over the weekend. One of the options reportedly mulled would involve issuing the vaccine candidate being developed by AstraZenaca and Oxford University emergency use authorization. A spokesperson for the U.S. Health and Human Services department, however, also told the Financial Times that it was absolutely false that an emergency use authorization would be issued before the US presidential election.

This week, the Republican National Convention (RNC) kicks off in Charlotte, North Carolina, days after former Vice President Joe Biden formally accepted the Democratic nomination for president at the Democratic National Convention (DNC) last week. While mostly virtual, some Republican leaders and delegates will be present in-person for Mondays events. Speakers for Monday are scheduled to include Former Ambassador Nikki Haley, Sen. Tim Scott (R., S.C.) and House Republican Whip Steve Scalise (R., La.), along with President Donald Trump, who will speak during each day of the four-day event.

On the earnings front, software company Palo Alto Networks (PANW)is set to report quarterly results after market close.

Here were the main moves in markets as of 4:02 p.m. ET:

S&P 500 (^GSPC): +34.21 (+1.01%) to 3,431.37

Dow (^DJI): +378.54 (+1.36%) to 28,308.87

Nasdaq (^IXIC): +67.92 (+0.60%) to 11,379.72

Crude (CL=F): +$0.09 (+0.21%) to $42.43 a barrel

Gold (GC=F): -$14.30 (-0.73%) to $1,932.70 per ounce

10-year Treasury (^TNX): +0.6 bps to yield 0.6460%

The three major indices held higher in intraday trading Monday afternoon and the Dow tracked toward its first close of more than 28,000 since February 21. Shares of Boeing and Dow Inc. led advances in the 30-stock index, with each stock rising more than 4.5%.

The energy, financials and materials sectors areas of the market that had lagged in recent months during the height of the pandemic led advances in the S&P 500. Tech stocks and the Nasdaq also advanced, but underperformed relative to the other two major indices. Small caps also rose, and the Russell 2000 tracked toward its first gain in three sessions.

Stocks rose to record levels shortly after market open Monday morning, adding to last weeks gains. Here were the main moves in markets, as of 10:03 a.m. ET:

S&P 500 (^GSPC): +19.93 points (+0.59%) to 3,417.09

Dow (^DJI): +163.18 points (+0.58%) to 28,093.51

Nasdaq (^IXIC): +53.12 points (+0.47%) to 11,366.91

Crude (CL=F): +$0.09 (+0.21%) to $42.43 a barrel

Gold (GC=F): +$0.80 (+0.04%) to $1,947.80 per ounce

10-year Treasury (^TNX): -1.5 bps to yield 0.623%

Shares of Apple rocketed to a record high of $515.14 just after market open Monday morning, sending the iPhone-makers total market capitalization well above the $2 trillion mark it first exceeded last week.

The move higher comes just before the companys previously announced four-for-one stock split takes effect. Every shareholder of record as of the end of trading Monday will receive three additional shares. Shares will begin trading on a split-adjusted basis next Monday, Aug. 31.

Story continues

The Chicago Federal Reserves National Activity Index fell more than expected in July from June, as manufacturing production and employment growth each decelerated amid a resurgence of coronavirus cases in some parts of the US.

The headline index came in at 1.18 for July, from Junes upwardly revised 5.33. Consensus economists expected the July index would come in at 3.7. Readings of zero indicate the national economy expanding at its average historical rate of growth, while positive values signal above-average growth.

Manufacturing industrial production increased at a more moderate 3.4% rate in July following a 7.4% rise in June. Employment-related indices contributed 0.38 points to the headline index, down from a 1.94-point contribution in June.

Earlier this month, President Donald Trump authorized a program to implement a $300 supplemental federal unemployment benefit, directing some $40 billion in disaster relief funds for states to distribute as payments to individuals for up to an estimated three to five weeks.

While states are able to make payments to individuals retroactive to Aug. 1, the new program is unlikely to help support consumer spending the biggest component of US economic activity this month, according to a new note from Goldman Sachs titled, The New $300 Benefit: Too Little Too Late for August Spending.

The lapse in the $600 unemployment insurance payments will results in a roughly $70bn decline in monthly personal income in August a sequential drag on consumer spending power of as much as 6.5% of PCE [personal consumption expenditures] in the month. At best, the new $300 payment would cover half of this decline if implemented in full this month, Goldman Sachs economist Blake Taylor said. But given delays in implementing the program and disbursing funds, the new program is unlikely to meaningfully support incomes until September.

Despite a high saving rate, this hit to income is likely to weigh on consumer spending and retail sales in August, Blake added.

Here were the main moves in equity markets, as of 7:15 a.m. ET:

S&P 500 futures (ES=F): 3,420.00, up 27.5 points or 0.81%

Dow futures (YM=F): 28,130.00, up 271.00 points, or 0.97%

Nasdaq futures (NQ=F):11,661.5, up 99.5 points, or 0.86%

Crude (CL=F): +$0.29 (+0.68%) to $42.63 a barrel

Gold (GC=F): +$11.70 (+0.60%) to $1,958.70 per ounce

10-year Treasury (^TNX): +0.1 bps to yield 0.641%

NEW YORK, NY - APRIL 02: Traders exit the floor of the New York Stock Exchange at the end of the trading day on April 2, 2013 in New York City. The Dow Jones Industrial average and the S&P 500 rose to new record highs on April 2, with the Dow finishing at a record close of 14,662. All three major indexes are up between about 10 percent and 12 precent for the year. (Photo by Spencer Platt/Getty Images)

Follow Yahoo Finance onTwitter,Facebook,Instagram,Flipboard,LinkedIn, andreddit.

Find live stock market quotes and the latest business and finance news

For tutorials and information on investing and trading stocks, check out Cashay

Continued here:

Stock market news live updates: Dow tops 28,000 for the first time since February as Covid-19 vaccine, treatment hopes rise - Yahoo Finance

Longtime health care journalist Gary Schwitzer uses the language of disaster warnings when discussing the challenges of covering COVID-19. In a recent interview with ABC network affiliate KSTP, Schwitzer said the speedy publication of preliminary research findings related to the coronavirus may create conditions for a perfect storm of pandemic misinformation. In an interview with Journalists Resource, he stressed the need for reporters to help audiences make sense of the tsunami of COVID-19 information.

Schwitzer, publisher of HealthNewsReview.org, urges journalists to make sure audiences understand the limits of what scientists know to date about COVID-19, especially as the world awaits an effective vaccine. One piece of advice: Please do not project certainty where certainty simply doesnt exist, he says.

To help reporters make sense of whats known and yet to be learned about COVID-19 vaccines, Journalists Resource asked for insights from several people with expertise studying or reporting on vaccines: Howard Bauchner, editor in chief of the academic journal JAMA; Helen Branswell, senior infectious diseases and global health reporter for the online news outlet STAT; Paul Offit, the director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at the Childrens Hospital of Philadelphia; Zachary Brennan, a reporter with POLITICOProwith years of experience covering the U.S. Food and Drug Administration; and Schwitzer, who is also an adjunct associate professor at the University of Minnesota School of Public Health.

Here are some of the tips they offered.

#1. Reporters must understand what the various levels of clinical trials can and cant tell us. Be wary of announcements about scientific data made through press releases rather than academic journal articles.

The U.S. Food and Drug Administration is the gatekeeper that decides which medical treatments can be used and marketed in the United States. Research trials of vaccines and other medicines are conducted in multiple phases. Its worth noting that research to support FDA applications can take place in other countries. The initial stage of testing a vaccine Phase 1 usually involves recruiting 20 to 100 healthy volunteers to take a treatment, according to a primer on clinical research from the FDA.

This initial Phase 1 trial does not reveal much about the effectiveness of vaccines, Branswell says.

They cannot tell you if a vaccine works, she says. They are designed to figure out what dose should be used and to see if the vaccine is safe enough to continue testing. She adds, Phase 2s are larger and can start to give you hints about whether the vaccine works or not. Phase 3 is where it becomes clear if a vaccine works or doesnt.

A few of the companies racing to make COVID-19 vaccines have released information about vaccine trials by press release, rather than by scientific publication, Branswell notes.

Their stock values soar; the market is crazy about COVID-19 vaccine news, she says. But in some cases, there is very little actual information in these releases.

The Cambridge, Mass., biotech firm Moderna, for example, issued a May 18 press release saying eight people vaccinated in their Phase 1 trial of its COVID-19 vaccine all generated antibodies part of the human immune systems response to fighting COVID-19.

Thats definitely better than the alternative, but the company didnt release enough information to really tell anybody anything, Branswell says. But its stock valuation exploded.

At the end of trading on May 18, Moderna shares commanded about $80 each, an increase of 20% from the previous closing price.

The next day, I wrote a piece saying there wasnt much there there in their release, Branswell says. I didnt say the vaccine didnt work, only that we couldnt tell anything from what they released.

Moderna shares fell May 19, closing at $71.67, a 10% drop from the previous day.

Schwitzer notes there has been a lot of highly optimistic promotion of early-stage research, even small studies involving animals. A May press release from the National Institutes of Health, for example, has the headline, Investigational ChAdOx1 nCoV-19 vaccine protects monkeys against COVID-19 pneumonia. The research the NIH highlighted rested largely on results seen in six rhesus macaques. The paper was posted to what is called a preprint server, to which the public generally has access.

The findings are not yet peer-reviewed but are being shared to assist the public health response to COVID-19, the NIH noted in its release.

In an effort to respond to the pandemic, there has been greater use of preprint servers to allow more sharing of information among scientists. Preprint servers allow researchers to post their findings without the layers of scrutiny, including peer review, required for publication in major journals, as Journalists Resource explained in this April tip sheet.

In a July article in JAMA about the challenges of reporting on COVID-19, Schwitzer and Richard Saitz, an associate editor at JAMA, said news coverage that focuses on a single study should stress that one piece of research alone rarely proves definitive. Journalists, they said, should consult other experts in the field and include their views in news stories about research.

#2. Let your audience know now they could experience at least some mild side effects from COVID-19 vaccines.

If these vaccines are going to make recipients feel crappy at least for a short time after vaccination people should be prepared for that, STATs Branswell says. Getting that information out in advance can effectively inoculate against the inevitable social media discussion that will come later, when people complain about how lousy they felt after getting vaccinated against COVID-19.

Medical professionals and scientists are working now to address public concerns about how safe the COVID-19 vaccines will be when ready for public use. In a May poll of more than 1,000 U.S. adults conducted for the Associated Press and NORC, a research institution at the University of Chicago, 31% indicated they were uncertain whether they would receive a COVID-19 vaccine and 20% indicated they would not take it.

Polling suggests that people are understandably a bit nervous about vaccines that are being developed at never-before-attempted speeds, Branswell says.

The reports available on early-stage trials of COVID-19 vaccines show many people enrolled in trials have experienced mild side effects that lasted for a few days. In July, for example, the journal The Lancet published early-stage results of one of the more advanced vaccine candidates, referred to as AZD1222, developed by Oxford University and the biopharmaceutical company AstraZeneca Plc in the United Kingdom. People who participated in the study were most likely to report side effects such as malaise and muscle aches and nausea in the days after the injection, with reports of these complications then ebbing, Pedro M. Folegatti of Oxfords Jenner Institute, and his co-authors reported in The Lancet.

The patients who participated in this study reported having one or more symptoms including temporary injection site pain and tenderness, mild-to-moderate headache, fatigue, chills, feverishness, malaise and muscle ache. At least two drug manufacturers have abandoned testing of their highest initial dose of their COVID-19 vaccine because they resulted in more severe Grade 3 side effects, Branswell said.

Grade 3 side effects are considered serious, but not life threatening, and could require medical care, according to the FDA.

#3. Explain to audiences the demographics of the pools of patients used to test vaccines.

Journalists should pay attention to the composition of the patient population when reporting on results of a clinical trial, JAMAs Bauchner says.

The question is who was in the study, he says. Was it people from 20 to 40 who were healthy? The results of such a trial might not apply to people aged 60 to 80, for example, or to unhealthy adults.

In medical journals, this demographic information usually appears in Table 1 of reported studies, Bauchner notes.

#4. Help your audience understand the limits of whats known about vaccines.

In an effort to share knowledge about the pandemic more quickly, major medical journals are publishing reports from preliminary stages of research, even Phase 1 testing, Bauchner says.

Because its the midst of a pandemic, were publishing studies that perhaps we may not have published at another time, Bauchner says.

Bauchner writes on this issue in a June editorial for JAMA, Editorial Evaluation and Peer Review During a Pandemic: How Journals Maintain Standards.

Audiences should also understand that it may take time for researchers to fully understand the side effects of the vaccine, Bauchner said. Clinical trials provide an initial gathering of safety data on treatments.

Also, Bauchner warns, reporting only the topline results of medical studies doesnt give readers a full picture of what scientists learned from their work. In medicine, researchers most often seek to calculate whats called a 95% confidence interval.

A National Institutes of Health backgrounder explains the 95% confidence interval with the following hypothetical example: If a study is 95% reliable, with a confidence interval of 47-53, that means if researchers did the same study over and over and over again with samples of the whole population, they would get results between 47 and 53 exactly 95% of the time. Confidence intervals, abbreviated as CI, can be set to 90% and 99%, but the 95% mark is most common in medicine.

Bauchner offers a hypothetical example of a study aimed at assessing whether a specific vaccine can prevent COVID-19 infections.

In this hypothetical trial, researchers find that the vaccine has a 40% success rate for preventing infection. But that number is simply researchers best estimate, based on a range of possible success rates reflected in the confidence interval.

In this hypothetical trial described by Bauchner, the confidence interval is fairly broad, with the actual rate of effectiveness likely ranging from a low of 20% to a high of 60%.

Thats a hard concept for people to understand, but its really going to be important, Bauchner says, referring to the 95% confidence interval. We dont ever have a definitive answer about how effective a vaccine is. We have a range and we try to express how likely that range is to be true.

#5. Build a network of sources, especially the kind who can walk you through study data.

POLITICO PROs Brennan recommends journalists covering COVID-19 vaccines get as many viewpoints as possible and be prepared to parse the data that companies present. STATs Branswell concurs.

Talk to vaccine experts. Find someone who can talk you through the appendices or the supplementary material the tables and figures, Branswell says. Reporters read words but the critical information in vaccine trial results is in the data. Sometimes, the data show things that the words dont describe, or at least downplay.

Journalists should also keep in mind the challenges of the new approaches used in developing many of the experimental COVID-19 vaccines. The FDA has not licensed the vaccines that use some of these new technologies in testing, such as an mRNA vaccine. Moderna describes its mRNA vaccine as a vehicle to introduce genetic codes for the proteins that pathogens use to cause a disease. Why does this matter? Says Branswell: The more experience the FDA has with a vaccine approach, the easier it is for their scientists to assess a new vaccine. Thats not the case with most of the COVID vaccines in development, at least the ones that are furthest along.

The Association of Health Care Journalists routinely holds webinars and posts articles to aid journalists in covering the pandemic. This month, the AHCJ posted a piece written by its medical studies core topic leader, Tara Haelle, titled Press release reporting is irresponsible especially in a pandemic.

Johns Hopkins University has a free online course of short videos that covers the basics of COVID-19, including vaccine development.

Earlier this year, the Knight Center for Journalism in the Americas at the University of Texas at Austin, offered an online course, Covering COVID-19 now and in the future. Materials for this class, created in partnership with UNESCO and the World Health Organization, are available on the Knight Center website. The class was offered in Spanish, French and Portuguese as well as English.

HealthNewsReviews.org stopped actively publishing in 2018, but Schwitzer and other contributors still post new articles periodically. The site offers many resources for reporting on medicine, including tip sheets such as one titled Tips for analyzing studies, medical evidence and health care claims.

The Childrens Hospital of Philadelphia provides a quick overview of major issues around COVID-19 vaccines on its Questions and Answers about COVID-19 Vaccines webpage.

The U.S. Department of Health and Human Services offers information about the Operation Warp Speed initiative for COVID-19 vaccines, including a timeline of its agreements with companies.

Journalists Resource created a tip sheet on how to assess the newsworthiness of medical research. Journalists Resource also created a comprehensive research-based piece that addresses questions on safety, approval, distribution and adoption of COVID-19 vaccines.

More here:

Reporting on COVID-19 vaccines: 5 tips to help journalists get it right - Journalist's Resource

Late Friday night Moderna tweeted that their Phase III study had come close to the halfway mark in recruiting the 30,000 or so subjects needed for the pivotal test of their Covid-19 vaccine mRNA-1273.

So I thought it was a good time to catch up with CEO Stphane Bancel on the timing of the readout, which is of intense interest around the world and particularly in Washington DC, where the top regulators and scientists involved repeatedly insist they wont tolerate any political interference in pushing a premature announcement of a win ahead of the election November 3rd.

In response to my email query, Bancel observed:

We have said we should be done in September with enrollment.

Event driven read out.

So the 2 key drivers of when we will know is

Infection rate

Efficacy (a high efficacy vaccine will read out sooner than a low efficacy vaccine)

Base case scenario is November read out

Best is October

This is in line with what Pfizer and BioNTech execs have been saying about their mRNA candidate. On Thursday night Pfizer put out a statement saying that they had recruited more than 11,000 subjects for their pivotal and the investigators were in line for a read out as early as October.

The faster they recruit, the quicker they can get the second shot in, and assess efficacy. For Moderna $MRNA the second shot comes on day 29, and for Pfizer/BioNTech its day 21. And that leaves the leading players neck-and-neck.

Its worth noting here that it typically takes years, not months, to get a vaccine through development and onto the market. Heres our ranking of the 28 vaccines in or near the clinic.

At this point just about every prominent government official connected to this has completely rejected the idea that political influence from the Trump White House would be allowed to push a positive declaration ahead of the election. That was capped by Peter Marks, the CBER chief who flat out vowed to resign if he saw any meddling in the timeline.

But President Trump isnt making it easy for the FDA. On Saturday morning Trump declared that the FDA was purposefully slowing down recruitment for vaccine and drug trials. And he suggested the deep state inside the agency could be pulling strings to trip up investigators, urging commissioner Stephen Hahn to speed things up in his remarks.

Theres no evidence at all of any deep state anti-Trump group operating at the FDA.

Trump followed up with a tweet criticizing the FDA again for yanking the emergency use authorization for his favorite Covid-19 drug hydroxy, which has been widely panned after multiple trial failures. But so far, Hahn hasnt budged on that. And any move now would instantly reignite charges of political influence.

Trumps tweet earned a quick retort from House Speaker Nancy Pelosi, who called it a dangerous attempt to inject himself into the scientific decisions of the the FDA.

For a look at all Endpoints News coronavirus stories, check out our special news channel.

See the original post:

UPDATED: The leaders in the race to develop a Covid-19 vaccine say they could have pivotal data in October but Trump claims FDA is slowing...

Visit the News Hub

Nasal delivery produces more widespread immune response than intramuscular injection

Researchers at Washington University School of Medicine in St. Louis have developed a COVID-19 vaccine delivered via the nose that protects mice from the virus. Shown is mouse lung tissue infected with SARS-CoV-2, the virus that causes COVID-19. On the left is lung tissue from a mouse that received a control vaccine that produced no protective effects. It shows a large number of inflammatory cells. On the right is lung tissue from a mouse that received a nasal vaccine encoding the virus' spike protein. The vaccine protected against infection, and large numbers of inflammatory cells are absent.

Scientists at Washington University School of Medicine in St. Louis have developed a vaccine that targets the SARS-CoV-2 virus, can be given in one dose via the nose and is effective in preventing infection in mice susceptible to the novel coronavirus. The investigators next plan to test the vaccine in nonhuman primates and humans to see if it is safe and effective in preventing COVID-19 infection.

The study is available online in the journal Cell.

Unlike other COVID-19 vaccines in development, this one is delivered via the nose, often the initial site of infection. In the new study, the researchers found that the nasal delivery route created a strong immune response throughout the body, but it was particularly effective in the nose and respiratory tract, preventing the infection from taking hold in the body.

We were happily surprised to see a strong immune response in the cells of the inner lining of the nose and upper airway and a profound protection from infection with this virus, said senior author Michael S. Diamond, MD, PhD, the Herbert S. Gasser Professor of Medicine and a professor of molecular microbiology, and of pathology and immunology. These mice were well protected from disease. And in some of the mice, we saw evidence of sterilizing immunity, where there is no sign of infection whatsoever after the mouse is challenged with the virus.

To develop the vaccine, the researchers inserted the virus spike protein, which coronavirus uses to invade cells, inside another virus called an adenovirus that causes the common cold. But the scientists tweaked the adenovirus, rendering it unable to cause illness. The harmless adenovirus carries the spike protein into the nose, enabling the body to mount an immune defense against the SARS-CoV-2 virus without becoming sick. In another innovation beyond nasal delivery, the new vaccine incorporates two mutations into the spike protein that stabilize it in a specific shape that is most conducive to forming antibodies against it.

Adenoviruses are the basis for many investigational vaccines for COVID-19 and other infectious diseases, such as Ebola virus and tuberculosis, and they have good safety and efficacy records, but not much research has been done with nasal delivery of these vaccines, said co-senior author David T. Curiel, MD, PhD, the Distinguished Professor of Radiation Oncology. All of the other adenovirus vaccines in development for COVID-19 are delivered by injection into the arm or thigh muscle. The nose is a novel route, so our results are surprising and promising. Its also important that a single dose produced such a robust immune response. Vaccines that require two doses for full protection are less effective because some people, for various reasons, never receive the second dose.

Although there is an influenza vaccine called FluMist that is delivered through the nose, it uses a weakened form of the live influenza virus and cant be administered to certain groups, including those whose immune systems are compromised by illnesses such as cancer, HIV and diabetes. In contrast, the new COVID-19 intranasal vaccine in this study does not use a live virus capable of replication, presumably making it safer.

The researchers compared this vaccine administered to the mice in two ways in the nose and through intramuscular injection. While the injection induced an immune response that prevented pneumonia, it did not prevent infection in the nose and lungs. Such a vaccine might reduce the severity of COVID-19, but it would not totally block infection or prevent infected individuals from spreading the virus. In contrast, the nasal delivery route prevented infection in both the upper and lower respiratory tract the nose and lungs suggesting that vaccinated individuals would not spread the virus or develop infections elsewhere in the body.

The researchers said the study is promising but cautioned that the vaccine so far has only been studied in mice.

We will soon begin a study to test this intranasal vaccine in nonhuman primates with a plan to move into human clinical trials as quickly as we can, Diamond said. Were optimistic, but this needs to continue going through the proper evaluation pipelines. In these mouse models, the vaccine is highly protective. Were looking forward to beginning the next round of studies and ultimately testing it in people to see if we can induce the type of protective immunity that we think not only will prevent infection but also curb pandemic transmission of this virus.

This work was supported by the National Institutes of Health (NIH), grant and contract numbers 75N93019C00062, R01 AI127828, R01 AI130591, R01 AI149644, R35 HL145242, HHSN272201400018C, HHSN272201200026C, F32 AI138392 and T32 AI007163; the Defense Advanced Research Project Agency, grant number HR001117S0019; a Helen Hay Whitney Foundation postdoctoral fellowship; and the Pulmonary Morphology Core at Washington University School of Medicine.

Diamond is a consultant for Inbios, Vir Biotechnology, NGM Biopharmaceuticals, and on the scientific advisory board of Moderna. The Diamond laboratory has received unrelated funding support from Moderna, Vir Biotechnology, and Emergent BioSolutions. Diamond, Curiel, Ahmed Hassan and Igor Dmitriev have filed a disclosure with Washington University for possible development of ChAd-SARS-CoV-2. Michael Holtzman is a member of the DSMB for AstroZeneca and founder of NuPeak Therapeutics. The Baric laboratory has received unrelated funding support from Takeda, Pfizer and Eli Lily.

Hassan AO, et al. A single-dose intranasal ChAd vaccine protects upper and lower respiratory tracts against SARS-CoV-2. Cell. Aug. 19, 2020.

Washington University School of Medicines 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Childrens hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Childrens hospitals, the School of Medicine is linked to BJC HealthCare.

Read the rest here:

Nasal vaccine against COVID-19 prevents infection in mice - Washington University School of Medicine in St. Louis

Two U.S. pharmaceutical giants, Pfizer and Moderna, are in the final phase of coronavirus vaccine development, and Oxford University is expected to start large-scale human trials of its vaccine in the U.S. this month. CBS News got an inside look at what happens during this phase, before the vaccine is approved for public use.

For Dr. Victoria Smith, who practices family medicine near New Orleans, COVID-19 is personal. She's lost three patients to the virus.

"I wanted to be part of the solution," she told CBS News chief medical correspondent Dr. Jon LaPook. So in late July, Smith became one of the first of 30,000 participants in Pfizer's Phase 3-vaccine trial.

"I'm not an immunologist, but by being part of a trial, I can be part of that research front as well," she said.

She received her first dose at Ochsner Medical Center in Louisiana. It's a double-blinded study, meaning neither she nor the researchers know whether she received the vaccine or just a placebo.

Every week, Pfizer sends packages of the vaccine and placebo to the Ochsner Phase 3 trial site. The vaccine is then stored in a freezer at a temperature of at least -60 degrees celsius (-76 Fahrenheit) to keep it stable.

Smith said she didn't have any doubts about the trial. "I trust the process," she said.

To be approved by the Food and Drug Administration, a COVID-19 vaccine must prevent or decrease the severity of the disease in at least 50% of vaccinated people.

"There's no evidence that the vaccine makes the disease worse at all. So that's really, really very encouraging," said Dr. Kathryn Edwards, who is on Pfizer's vaccine safety committee.

Once a week, the five members of the committee video chat to carefully look over data and scan for any adverse effects especially serious ones that lead to hospitalizations.

"We're very, very cautious in how we look at the data," Edwards said. "Certainly if there were severe reactions, we would get that information right away."

Edwards said there's no evidence so far that the vaccine causes serious reactions, but that mild reactions are common, and should not deter anyone from getting vaccinated.

"You may have a sore arm or you may have a little tenderness or you may have a little headache or you may have a little fever. So those are things to be expected," she said. "It's just your immune system getting tweaked and you're making a better response."

Trial participants are required to self-monitor and log their symptoms on an app, recording their temperature and any reactions every day for a week after each injection. They will be asked to continue logging any symptoms on a weekly basis for two years.

On Wednesday, after 21 days, Smith received her final dose. Early trial results show a second shot boosts neutralizing antibodies that block the virus' ability to attack our bodies.

"If you look at the immune responses in the people that got one dose and two, the two doses, their immune response was higher. So I think that... they're probably going to need two doses," Edwards said.

But a vaccine is not expected to mean an immediate return to the way things were.

"If the vaccine's 50% effective, it's not going to reduce all the disease," Edwards said. "There's social distancing, the masks, these things may need to continue and people will continue to need to have some thought about what their activities have and the implications that they have for the rest of the community."

Originally posted here:

Inside the "very cautious" U.S. human trial of a COVID-19 vaccine - CBS News

As fall approaches rapidly, many are wondering if the race for a vaccine will bear fruit as early as January 2021.

I am a physician-scientist and infectious diseases specialist at the University of Virginia, where I care for patients and conduct research into COVID-19. I am occasionally asked how I can be sure that researchers will develop a successful vaccine to prevent COVID-19. After all, we still dont have one for HIV, the virus that causes AIDS.

Here is where the current research stands, where I think we will be in five months, and why you can be optimistic about the delivery of a COVID-19 vaccine.

In as many as 99% of all COVID-19 cases, the patient recovers from the infection, and the virus is cleared from the body.

Some of those who have had COVID-19 may have low levels of virus in the body for up to three months after infection. But in most cases these individuals can no longer transmit the virus to other people 10 days after first becoming sick.

It should therefore be much easier to make a vaccine for the new coronavirus than for infections such as HIV where the immune system fails to cure it naturally. SARS-CoV-2 doesnt mutate the way that HIV does, making it a much easier target for the immune system to subdue or for a vaccine to control.

A vaccine will protect, in part, by inducing the production of antibodies against the spike protein on the surface of SARS-CoV-2, the virus that causes COVID-19.

The virus needs the spike protein to attach to and enter human cells to reproduce. Researchers have shown that antibodies, like those made by the human immune system, bind to the spike protein, neutralize it, and prevent the coronavirus from infecting cells in laboratory culture.

Vaccines in clinical trials have been shown to raise anti-spike antibodies that block virus infection in cells in the lab.

At least seven companies have developed monoclonal antibodies, laboratory-manufactured antibodies that recognize the spike protein. These antibodies are entering clinical trials to test their ability to prevent infection in those who are exposed, for example, through a household contact.

Monoclonal antibodies may also be effective for treatment. During an infection, a dose of these monoclonal antibodies could neutralize virus, giving the immune system a chance to catch up and manufacture its own antibodies to combat the pathogen.

The spike protein has many locations where antibodies can bind to and neutralize the virus. Thats good news because with so many vulnerable spots, it will be difficult for the virus to mutate to avoid a vaccine.

Multiple parts of the spike would need to mutate to evade neutralizing anti-spike antibodies. Too many mutations to the spike protein would change its structure and render it incapable of binding to ACE2, which is key to infecting human cells.

Safety of a new COVID-19 vaccine is improved by researchers understanding of potential vaccine side effects and how to avoid them.

One side effect seen in the past was antibody-dependent enhancement of infection. This occurs when antibodies dont neutralize the virus but instead allow it to enter into cells via a receptor intended for antibodies. Researchers have found that by immunizing with the spike protein, high levels of neutralizing antibodies can be produced. This lessens the risk of enhancement.

A second potential problem posed by some vaccines is an allergic reaction that causes inflammation in the lung, as was seen in individuals who received a respiratory syncytial virus vaccine in the 1960s. This is dangerous because inflammation in the lung air spaces can make it difficult to breathe. However, researchers have now learned how to design vaccines to avoid this allergic response.

The U.S. government is supporting the development of several different vaccines via Operation Warp Speed.

The goal of Operation Warp Speed is to deliver 300 million doses of a safe and effective vaccine by January 2021.

The U.S. government is making a major investment, committing US$8 billion to seven different COVID-19 vaccines.

By supporting multiple COVID-19 vaccines, the government is hedging its bets. Only one of these vaccines needs to prove safe and effective in clinical trials for a COVID-19 vaccine to be made available to Americans in 2021.

Phase I and phase II trials test if a vaccine is safe and induces an immune response. Already the results to date from three different vaccine trials are promising, triggering the production of anti-spike neutralizing antibodies levels that are two- to four-fold higher than those seen in people who have recovered from COVID-19.

Moderna, Oxford, and Chinese company CanSino have all demonstrated the safety of their vaccines in phase I and phase II trials.

During a phase III trial, the final step in vaccine development process, the vaccine is tested on tens of thousands of individuals to determine if it works to prevent infection with SARS-CoV-2, and that it is safe.

The vaccine produced by Moderna and NIH and the vaccine from Oxford-AstraZeneca began phase III trials in July. Other COVID-19 vaccines will be starting phase III within weeks.

Operation Warp Speed is paying for the production of millions of doses of vaccines and supporting vaccine manufacturing at an industrial scale even before researchers have demonstrated vaccine efficacy and safety.

The advantage of this strategy is that once a vaccine is proven safe in phase III trials, a stockpile of it will already exist and it can be distributed immediately without compromising full assessment of safety and efficacy.

This is a more prudent approach than that of Russia, which is vaccinating the public with a vaccine before it has been shown to be safe and effective in phase III.

McKesson Corp., the largest vaccine distributor in the U.S., has already been contracted by the CDC to distribute a COVID-19 vaccine to sitesincluding clinics and hospitalswhere the vaccine will be administered.

I believe that it is realistic that we will know sometime in late 2020 whether some COVID-19 vaccines are safe, exactly how effective they are, and which ones should be used to vaccinate the U.S. population in 2021.

William Petri is a professor of medicine at the University of Virginia

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

Follow this link:

9 reasons to be optimistic that a COVID-19 vaccine will be widely available in 2021 - Fast Company

Public health experts in San Diego and Mexico caution that the best way to control COVID-19 long-term is with a safe, effective vaccine available on both sides of the U.S.-Mexico border.

The U.S. government has inked deals with leading vaccine developers in a bid to deliver 300 million doses of a COVID-19 vaccine by January 2021. But its going to take a global approach to quell the worst pandemic the world has faced in a century, says Steffanie Strathdee, UC San Diegos associate dean of global health sciences.

Were going to need to make sure that we dont leave segments of our population behind. We have a shared population in the border region, said Strathdee, who has studied public health at the U.S.-Mexico border for more than 15 years.

We cant just think that we need a shot for every American and that will take care of it.

Tens of thousands of people cross the U.S.-Mexico border at San Ysidro every day for work, tourism and to visit family.

Thats slowed a bit since both countries banned nonessential travel in March. But theres still plenty of traffic at the border, and travelers in both directions could carry the coronavirus, even if they feel fine.

San Diego County recently opened a free, voluntary COVID-19 testing site outside San Ysidros PedEast crossing. But by the time someone gets a positive test result back, they could have already infected family, friends or coworkers.

The best way to tamp down on transmission would be to have nearly everyone on both sides of the border vaccinated, says Dr. Andrs Smith, medical director of emergency services at Sharp Chula Vista Medical Center.

Whatever happens on one side is going to affect the other, said Smith, president of the board of directors for Cruz Roja de Tijuana. Both countries, by doing the vaccination, are going to faster control the spread.

During the 2009 swine flu pandemic, San Diego County set up vaccination clinics along the border for those entering the U.S., according to county public health officer Dr. Wilma Wooten.

More than likely, once vaccines are available for COVID-19, we will have stations there to do the same thing, said Wooten during an Aug. 14 press briefing.

But a study led by researchers at the Centers for Disease Control and Prevention showed that, of a sample of nearly 560 people who crossed the border in early 2010, only about one in four had been vaccinated.

About half of study participants entered the U.S. through the San Ysidro port of entry. The most common reasons people cited for not getting a vaccine were time constraints and their belief that they were unlikely to get infected.

The virus that causes COVID-19, however, is not the flu. The coronavirus is deadlier and more contagious than influenza, and researchers are just beginning to understand COVID-19s lingering effects in patients whose bodies have cleared the virus.

Thats made some people open to receiving a COVID-19 vaccine if one were available.

Erica Gomez, who lives in Tijuana and used to work in San Ysidro, is one of them. She crossed the border by foot to pick up an unemployment check and got tested for the coronavirus at PedEast.

Gomez said she is willing to make the trek again once a vaccine is available.

I would definitely get one, she said. But first, I want to see if there are any side effects.

According to a recent poll, roughly one in three Americans would not take a free COVID-19 vaccine approved by the Food and Drug Administration. Vaccine skepticism doesnt pose nearly as much of a problem in Mexico, said Dr. Carlos Magis, professor of public health at the National Autonomous University of Mexico.

Mexico has a very good vaccination program, Magis said. We are not charging. We are doing vaccination in the street. We are going to the houses of people.

Instead, the main challenge could be access.

Theres precedent for such concerns. Mexico was one of the first countries hit by swine flu but didnt get access to a vaccine until after the United States and Europe.

The country is trying to ensure that doesnt happen again.

Mexico and Argentina recently announced a deal with AstraZeneca to produce and distribute 150 to 250 million doses of the British Pharma giants COVID-19 vaccine throughout Latin America if it proves effective in clinical trials. Manufacturing could start as soon as early 2021, said Sylvia Varela, head of AstraZeneca Mexico. During an Aug. 13 press briefing, President Andrs Manuel Lpez Obrador assured that the vaccine would be provided at no cost to all Mexicans.

But Mexico is still moving forward with backup plans just in case.

Researchers (from left to right) Manuel Alejandro Carballo, Julio Enrique Valencia and Manuel Aguilar Yaez, working at the UABC Faculty of Science laboratory

(Courtesy photo)

Researchers at the Autonomous University of Baja California in Ensenada are participating in one of Mexicos four ongoing COVID-19 vaccine projects.

The team recently designed their candidate vaccine and are conducting preliminary studies in mice in collaboration with the University of California San Diego.

We had some concern that in Mexico, as has happened before, there would not be a supply of vaccines, said Jos Manuel Aguilar Yez, leader of the Jonas Salk Initiative, a social non-profit currently developing one of the vaccines.

Both Mexican officials and a spokesman with the Jonas Salk Initiative confirmed recently that the vaccine projects continue despite the announced deal with AstraZeneca.

Go here to read the rest:

Why you cant control COVID-19 in San Diego without a vaccine on both sides of the US-Mexico border - The San Diego Union-Tribune

CHICAGO - Christina Glover gets a flu shot each year and has always ensured her daughters pediatric vaccines are on schedule.

Yet the 36-year-old from the South Side of Chicago said shed be nervous about getting a COVID-19 vaccine once one emerges and hits the market.

Its the fact that its new, Glover said. You have your right to be concerned about anything - vaccines, any type of medication - you have a right to be concerned with how its going to interact with your body. ... You want to see the reaction its going to have on other people.

As scientists across the globe race to create a COVID-19 vaccine that is safe and effective, the American public appears sharply divided when it comes to the prospect of getting vaccinated against the new virus, which has so far infected roughly 5.5 million and killed more than 172,000 in the United States.

A survey earlier this week from NBC News/SurveyMonkey Weekly Tracking Poll showed that more than half of American adults either wouldnt get a COVID-19 vaccine once one is available or are unsure whether theyll get immunized. The poll found 44% said they would get the vaccine, while 22% reported they wouldnt get one and another 32% remain uncertain.

A Gallup survey earlier this month indicated that 35% of Americans would not get a free vaccine against COVID-19, if one were available and approved by the Food and Drug Administration. Another 65% responded that they would get the shot, with those identifying as Democrats far more in favor than Republicans.

Political leaders and health experts have taken up the challenge of getting the public on board, calling a future COVID-19 vaccine the key to fighting the virus and a return to normalcy. Gov. J.B. Pritzker has said Illinois wont be able to move on to phase five of the state reopening plan until a vaccine or highly effective treatment is widely available, or new cases are eliminated over a sustained period.

Chicago Mayor Lori Lightfoot earlier this month announced plans for a vaccine education initiative, fearing some residents will have reservations about getting a COVID-19 immunization.

I worry that even once we get a vaccine, that because of the speed with which its going to be brought into production, that people are going to be reluctant to take it, Lightfoot had said. So were starting now to do a lot of education about vaccines in general.

As for Glover, she said she recognizes the tension between individual health care rights versus the need to quell an international pandemic.

As a licensed practical nurse, she said she might have to get a future COVID-19 vaccine if it becomes required by her employer. And Glover said she understands the gravity of the illness: She said she contracted the coronavirus in late March. She suffered from aches, chest pains, a sore throat, shortness of breath and a loss of taste and smell through early April.

But she believes everyone should have the right to make their own medical decisions, noting that some might have religious objections or other personal concerns. While she always gets immunized to protect herself against the flu, she said she doesnt judge others who forgo the shot.

I just believe people should have a choice, they should be able to decline if they dont want to get it, she said. I understand why health care facilities would want to make it mandatory to help prevent the spread. But at the same time, to each their own. Its an individual choice.

William Taylor, 36, of the Lakeview neighborhood, said hes eager to get a coronavirus vaccine, even an early version of the vaccine if it were available to me.

I am hopeful that we could see a vaccine sooner than usual because of the serious upheaval (COVID-19) has caused and all of the resources being thrown at this, he said.

While there is no vaccine available yet, about two dozen potential COVID-19 vaccines are in various stages of testing across the globe. The Trump administration project Operation Warp Speed has dedicated billions of taxpayer dollars to fast-track a safe, effective and widely distributed vaccine against the new virus, with the goal of producing 300 million doses by January. The nations top infectious disease expert, Dr. Anthony Fauci, last month said he remained cautiously optimistic that we will have a vaccine by the end of this year and as we go into 2021.

Yet once a vaccine is available, getting the greater public on board and immunized could be the next hurdle.

I personally will not, said Lisa Casas, 54, of west suburban Itasca. The flu vaccine has been around forever and most years its not even the correct strain. I dont believe in vaccines for viruses.

While Casas has sidestepped the flu shot, she said she made sure her daughters had childhood vaccines required for school.

I believe being healthy, eating right and exercise help to fight viruses and diseases, she added. But in saying that, it should still be everyones choice as to what they do with their health.

Public health officials already have some difficulty convincing adults to get flu shots each year. A poll in late 2019 showed 37% of adults didnt plan to get the flu vaccine that season, according to research from NORC at the University of Chicago. Some reasons for forgoing the shot included concerns about side effects, a belief that the vaccine didnt work very well, the respondent reported never getting the flu and a dislike for needles, according to the survey.

Policymakers and medical experts also face opposition from anti-vaxxers, individuals and groups opposed to vaccines already on the market, whose opinions are often based on discredited research or debunked claims linking vaccines to other illnesses.

Even though no vaccine currently exists, an online petition opposing mandatory COVID-19 vaccines on the website LifeSite has garnered more than 800,000 signatures. Tens of thousands have also signed a change.org petition opposing mandatory COVID-19 vaccines in Canada.

Freedom and individual choice are main themes in both petitions.

We have managed to convince ourselves that the people whose healths are affected by a virus are much more important than the people whose lives, freedoms and livelihoods are being destroyed by this same virus, the Canadian petition reads.

Sometimes perceptions of the severity of the virus can shape vaccination views. David Cassiere, 52, of west suburban Sleepy Hollow, said he would most likely not get a COVID-19 vaccine, mostly due to concerns over possible side effects.

I would not be one of the first people lined up, he said.

He said the only way hed be convinced is if 99% or more of those immunized dont contract the virus - and even then hed likely wait at least a couple of seasons or calendar years to learn more about its safety.

Cassiere added that he fears the economic devastation caused by quarantines and stay-in-place orders more than he fears the actual virus.

I think weve erred too far restricting peoples livelihoods and commerce by quarantining everybody rather than asking people who are more at risk to do quarantining themselves, he said. Im not saying Illinois is wrong and Wisconsin is right - but I think there are other states that might be more in the middle, that are closer to having it right.

Like Cassiere, some Chicago-area residents who expressed reluctance to get vaccinated against COVID-19 were concerned about possible side effects; others worried about contracting the coronavirus from the shot, even though most of the leading vaccine candidates currently being tested dont contain a live virus and wouldnt cause infection.

Public uncertainty about whether to get a vaccine that hasnt even been developed doesnt surprise Dr. Kelly Michelson, professor of pediatrics and director of the Center for Bioethics and Medical Humanities at Northwestern University Feinberg School of Medicine.

First of all, and I think importantly, there is no vaccine now, said Michelson, who is also an attending physician at Ann and Robert H. Lurie Childrens Hospital. We dont really have the relevant information. Is it an effective vaccine? How effective is it? ... So it doesnt surprise me that people are unwilling to commit to taking a vaccine they know nothing about.

Once more is known about a future coronavirus vaccine, communication between patients and clinicians will play an important role, Michelson said.

She says good information and an open dialogue can often allay the concerns of patients who have questions about existing vaccines that have been around for years, with proven records of safety and effectiveness.

The vaccines that we have on the market that are currently tested, we have a good amount of information about, and I can say with certainty that people should get their flu vaccines, that its good for them, she said. If we do have a coronavirus vaccine, its going to be very important for clinicians - and for the public - to have good information about what it is.

Michael Barrett, 70, of northwest Indiana, said he looks forward to the day when a COVID-19 vaccine is widely available.

I would have no problem with it, even with limited trials, said Barrett, who was born and raised in Chicago but now lives in the Chesterton, Indiana, area. Weve got way more to gain at our age than to not try it. Its crazy not to. Hopefully if everyone gets it, life can go back to normal.

Hes concerned that some parts of the country are reopening too quickly, spurring outbreaks of the virus. Even as governments are loosening regulations, he believes that many retirees and individuals with underlying health conditions will continue to be worried about venturing out, further hampering the economy.

He wants to go out to dinner with family and friends. He and his wife long to travel again.

We so much miss that life we had before the virus, he said.

View original post here:

A COVID-19 vaccine still hasn't emerged but some are already wary of it - Ponca City News