Moderna to Trial HIV and Flu Vaccines With mRNA Technology

The astonishing success of COVID-19 vaccines may signal a breakthrough in disease prevention technologyModerna is developing influenza and HIV vaccines using mRNA technology, the backbone of its effective COVID-19 vaccine. The biotech company is expected to launch phase 1 trials for its mRNA flu and HIV vaccines this year. If successful, mRNA may offer a silver lining to the decades-long fight against HIV, influenza, and other autoimmune diseases. Traditional vaccines often introduce a weakened or inactive virus to one’s body. In contrast, mRNA technology uses genetic blueprints, which build proteins to train the immune system to fight off the virus. Since mRNA teaches the body to recognize a virus, it can be effective against multiple strains or variants as opposed to just one.

The mRNA platform makes it easy to develop vaccines against variants because it just requires an update to the coding sequences in the mRNA that code for the variant,”  said Rajesh Gandhi, MD, an infectious diseases physician at Massachusetts General Hospital and chair of HIV Medicine association.

Future mRNA vaccines have the potential to ward off multiple diseases with one shot, according to the Centers for Disease Control and Prevention (CDC).  Current mRNA vaccines, as demonstrated in their use against COVID-19, already appear to be less susceptible to new variants. “Based on its success in protecting against COVID-19, I am hopeful that mRNA technology will revolutionize our ability to develop vaccines against other pathogens, like HIV and influenza,” Gandhi says.

Moderna’s flu and HIV vaccines are still in early development stages, having yet to undergo their clinical trials. Still, if they prove successful, the mRNA-based treatment could dramatically change health care — both in expediting the route to immunity and by providing a solution to illnesses that have been around for decades. Scientists currently make annual alterations to the typical flu shot to keep up with the viruses in circulation. But a successful mRNA vaccine could provide a far more effective alternative.

An approved mRNA flu vaccine could be administered every other year rather than annually, explained virologist Andrew Pekosz, PhD. This is because mRNA accounts for variants and produces a stronger and longer-lasting immune response than that of the current flu vaccine, he says. The influenza vaccine is similar to the COVID-19 vaccine because the viruses have similar characteristics and necessary treatments, according to Pekosz.

However, a potential concern lies in the level of public immunity prior to receiving a vaccine. Since the flu has been around since the early 1900s, an mRNA vaccine could potentially boost older or less effective antibody responses rather than targeting current strains, Pekosz adds. “There’s no way to answer that question except to do some clinical trials, and see what the results tell us”.

Source: https://www.verywellhealth.com/

Moderna Is Testing new Vaccine Stored in Refrigerators, no More in Freezers

Moderna Inc said it had dosed the first participant in an early-stage study of a new COVID-19 vaccine candidate that could potentially be stored and shipped in refrigerators instead of freezers. The company said its new candidate could make it easier for distribution, especially in developing countries where supply chain issues could hamper vaccination drives.

The early-stage study will assess the safety and immunogenicity of the next-generation vaccine, designated as mRNA-1283, at three dose levels, and will be given to healthy adults either as a single dose or in two doses 28 days apart, the company said. Moderna also plans to evaluate the new vaccine, mRNA-1283, as a potential booster shot in future studies.

Last week, Moderna began dosing the first participants in a study testing COVID-19 booster vaccine candidates targeting the variant, known as B.1.351, that first emerged in South Africa.

The booster vaccine candidates, designated mRNA-1273.351, will be tested in a trial of both a variant-specific shot and a multivalent shot, according to the company’s announcement.

Janssen Vaccine could be Rolled Out in Europe by March 15

The European Medicines Agency (EMA) has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V. Janssen is a subsidiary of the giant pharma-company Johnson & Johnson.

EMA’s human medicines committee (CHMP) will assess the vaccine, known as COVID-19 Vaccine Janssen, under an accelerated timetable. The Committee could issue an opinion by the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust.

Such a short time for evaluation is only possible because EMA has already reviewed some data during a rolling review. During this phase, EMA assessed quality data and data from laboratory studies which looked at how well the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2 (the virus that causes COVID-19). The Agency also looked at clinical safety data on the viral vector used in the vaccine.

EMA is now assessing additional data on the efficacy and safety of the vaccine as well as its quality. If EMA concludes that the benefits of the vaccine outweigh its risks, it will recommend granting a CMA. The European Commission will then issue a decision on whether to grant a CMA valid in all EU and EEA Member States within days.

This is the fourth CMA application for a COVID-19 vaccine since the start of the current pandemic. It comes after EMA’s evaluation of vaccines from BioNTech/Pfizer, Moderna and AstraZeneca. These vaccines are now authorised in the EU and are among the tools Member States are using to combat COVID-19.

Source: https://www.ema.europa.eu/

Katalin Kariko, RNA Hero, Future Nobel Prize

The development of the Pfizer-BioNTech coronavirus vaccine, the first approved jab in the West, is the crowning achievement of decades of work for Hungarian biochemist Katalin Kariko, who fled to the US from communist rule in the 1980s.

When trials found the Pfizer-BioNTech coronavirus vaccine to be safe and 95 percent effective in November, it was the crowning achievement of Katalin Kariko’s 40 years of research on the genetic code RNA (ribonucleic acid). Her first reaction was a sense of “redemption,” Kariko told The Daily Telegraph.

I was grabbing the air, I got so excited I was afraid that I might die or something,” she said from her home in Philadelphia. “When I am knocked down I know how to pick myself up, but I always enjoyed working… I imagined all of the diseases I could treat.”

Born in January 1955 in a Christian family in the town of Szolnok in central Hungary – a year before the doomed heroism of the uprising against the Soviet-backed communist regimeKariko grew up in nearby Kisujszellas on the Great Hungarian Plain, where her father was a butcher. Fascinated by science from a young age, Kariko began her career at the age of 23 at the University of Szeged’s Biological Research Centre, where she obtained her PhD.

It was there that she first developed her interest in RNA. But communist Hungary’s laboratories lacked resources, and in 1985 the university sacked her. Consequently, Kariko looked for work abroad, getting a job at Temple University in Philadelphia the same year. Hungarians were forbidden from taking money out of the country, so she sold the family car and hid the proceeds in her 2-year-old daughter’s teddy bear. “It was a one-way ticket,” she told Business Insider. “We didn’t know anybody.”

Not everything went as planned after Kariko’s escape from communism. At the end of the 1980s, the scientific community was focused on DNA, which was seen as the key to understanding how to develop treatments for diseases such as cancer. But Kariko’s main interest was RNA, the genetic code that gives cells instructions on how to make proteins.

At the time, research into RNA attracted criticism because the body’s immune system sees it as an intruder, meaning that it often provokes strong inflammatory reactions. In 1995, Kariko was about to be made a professor at the University of Pennsylvania, but instead she was consigned to the rank of researcher.

Usually, at that point, people just say goodbye and leave because it’s so horrible,” Kariko told medical publication Stat. She went through a cancer scare at the time, while her husband was stuck in Hungary trying to sort out visa issues. “I tried to imagine: Everything is here, and I just have to do better experiments,” she continued. Kariko was also on the receiving end of sexism, with colleagues asking her the name of her supervisor when she was running her own lab.

Kariko persisted in the face of these difficulties. “From outside, it seemed crazy, struggling, but I was happy in the lab,” she told Business Insider. “My husband always, even today, says, ‘This is entertainment for you.’ I don’t say that I go to work. It is like play.” Thanks to Kariko’s position at the University of Pennsylvania, she was able to send her daughter Susan Francia there for a quarter of the tuition costs. Francia won gold on the US rowing team in the 2008 and 2012 Olympics.

It was a serendipitous meeting in front of a photocopier in 1997 that turbocharged Kariko’s career. She met immunologist Drew Weissman, who was working on an HIV vaccine. They decided to collaborate to develop a way of allowing synthetic RNA to go unrecognised by the body’s immune system – an endeavour that succeeded to widespread acclaim in 2005. The duo continued their research and succeeded in placing RNA in lipid nanoparticles, a coating that prevents them from degrading too quickly and facilitates their entry into cells.

The researchers behind the Pfizer-BioNTech and Moderna jabs used these techniques to develop their vaccines.

Source: https://www.france24.com/

Emergency Use Authorization of the J&J Covid Vaccine is Imminent

The Johnson & Johnson vaccine is getting a lot of people excited. Not only is it another potential option to protect more people from COVID-19, but their vaccine is only one dose, making it a lot easier to reach a broad swath of the population.

In Orange County, the fourth-highest county in the state for vaccine distribution, more than 82,000 initial doses have gone out. Across the sunshine state, more than 1.6 million Floridians have received at least their first dose with nearly 300,000 having completed their vaccine series. Nationwide, the U.S. is inching closer toward 30 million Americans having received at least one dose of the vaccine to protect them against COVID-19.

Johnson & Johnson’s vaccine isn’t approved just yet but it is expected to become  the third vaccine for roll out across the country. With just a single dose needed, health leaders say this could be a game changer.  Johnson & Johnson’s vaccine is only 66 percent effective compared to the 90 plus efficacy rate of both Pfizer and Moderna’s vaccine. However, health leaders stress that data is still promising. And Johnson & Johnson’s doses can remain stable for two years at -4 degree temperatures or at least three months when stored at 36 to 46 degree (8 degree  Celsius) temperatures.

Johnson & Johnson say they have product ready to ship out immediately pending approvals. They’re expected to file for emergency use authorization for their vaccine early February.

https://www.baynews9.com/

New Oxford/AstraZeneca’s Coronavirus Vaccine To Cost Just £2 Per Dose

Britain could have 19million doses of Oxford and AstraZeneca‘s coronavirus vaccine by the end of the year after clinical trials showed it is up to 90 per cent effective at preventing infection and can be stored cheaply in a fridge. President of AstraZeneca, Tom Keith-Roach said today that, on top of the four million doses on standby for the UK, a further 15million could be ready to roll out by the end of next month. They will be given to healthcare workers and the elderly first, subject to approval by regulators.

The vaccine is expected to cost just £2 per dose and can be stored in ordinary equipment, unlike other jabs made by Pfizer and Moderna that showed similarly promising results last week but need to be kept in ultra-cold temperatures using expensive equipment.  It’s also a fraction of the price, with Pfizer‘s costing around £15 per dose and Moderna‘s priced at about £26 a shot.

Oxford‘s trials found the jab has a nine in ten chance of working when administered as a half dose first and then a full dose a month later. Efficacy drops to 62 per cent when someone is given two full doses a month apart.

https://www.dailymail.co.uk/

Pfizer Says Its COVID-19 Vaccine Is 95% Effective

Pfizer and BioNTech said Wednesday that a final data analysis found their coronavirus vaccine was 95% effective in preventing COVID-19 and, in addition, appeared to fend off severe disease.

Vaccine, called BNT162b2, was highly effective against the virus 28 days after the first dose, and its effectiveness was consistent across all ages, races and ethnicities, the drugmakers said. Additionally, the elderly, who are seen as at high risk of severe illness from COVID-19, saw vaccine effectiveness of more than 94%, they added.

The final analysis underlines the results of the positive interim efficacy analysis announced on November 9,” BioNTech CEO Ugur Sahin said in a statement. “The data indicates that our vaccine … is able to induce a high rate of protection against COVID-19 only 29 days after the first dose. In addition, the vaccine was observed to be well-tolerated in all age groups with mostly mild to moderate side effects, which may be due in part to the relatively low dose.”

The vaccine also appeared to prevent severe disease in volunteers. There were 10 cases of severe cases of COVID-19 observed in the phase three trial, with nine of the cases occurring in the placebo group, the companies said. There were also no “serious” safety concerns, they said, with most adverse events resolving shortly after vaccination. The company’s shares jumped 3% in premarket trading.

The final analysis evaluated 170 confirmed COVID-19 infections among the late-stage trial’s more than 43,000 participants. The companies said 162 cases of COVID-19 were observed in the placebo group versus eight cases observed in the group that received its two-dose vaccine. That resulted in an estimated vaccine efficacy of 95%, they said.

The news comes more than a week after the companies announced that their vaccine was more than 90% effective and two days after Moderna said preliminary phase three trial data showed its vaccine was 94.5%. Both vaccines use messenger RNA, or mRNA, technology. It’s a new approach to vaccines that uses genetic material to provoke an immune response.

A safe and effective vaccine is seen by investors and policymakers as a solution to get the global economy back on track after the pandemic wreaked havoc on nearly every country across the globe and upended businesses. The virus continues to spread rapidly, with more than 55.6 million cases worldwide and at least 1.33 million deaths as of Wednesday, according to data compiled by Johns Hopkins University.

Pfizer and BioNTech‘s initial results on Nov. 9 were based on the first interim efficacy analysis conducted by an external and independent Data Monitoring Committee from the phase three clinical trial. The independent group of experts oversees U.S. clinical trials to ensure the safety of participants. Medical experts note it remains unclear how long the vaccines will provide immunity and whether or how often people may need periodic booster shots.

These vaccines are going to be approved and then rolled out with basically a few months’ worth of data. You’re not going to do a two-year study to see whether it’s effective for two years with more than 200,000 people dying this year” in the U.S., Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said in a recent interview.

Pfizer said it plans to submit an application for emergency use authorization to the Food and Drug Administrationwithin days.” Pfizer CEO Albert Bourla said at Tuesday’s New York Times Dealbook conference that the company had accumulated enough safety data needed to submit the vaccine for review.

The companies reiterated that they expect to produce up to 50 million doses this year and up to 1.3 billion doses in 2021. They also said they are “confident” in their ability to distribute the vaccine, which requires a storage temperature of minus 94 degrees Fahrenheit. By comparison, Moderna‘s vaccine can be stored for up to six months at negative 4 degrees Fahrenheit.

Source: https://www.nbcdfw.com/

Moderna’s coronavirus vaccine is 94.5% effective

The Moderna vaccine is 94.5% effective against coronavirus, according to early data released Monday by the company, making it the second vaccine in the United States to have a stunningly high success rate.”These are obviously very exciting results,” said Dr. Anthony Fauci, the nation’s top infectious disease doctor. “It’s just as good as it gets — 94.5% is truly outstanding.”

Moderna heard its results on a call Sunday afternoon with members of the Data Safety and Monitoring Board, an independent panel analyzing Moderna‘s clinical trial data.
It was one of the greatest moments in my life and my career. It is absolutely amazing to be able to develop this vaccine and see the ability to prevent symptomatic disease with such high efficacy,” said Dr. Tal Zacks, Moderna‘s chief medical officer.

Vaccinations could begin in the second half of December, Fauci said. Vaccinations are expected to begin with high-risk groups and to be available for the rest of the population next spring.

The company says its vaccine did not have any serious side effects. A small percentage of those who received it experienced symptoms such as body aches and headaches.
Moderna plans to apply to the US Food and Drug Administration for authorization of its vaccine soon after it accumulates more safety data later this month.

Fauci says he expects the first Covid-19 vaccinations to begin “towards the latter part of December, rather than the early part of December.”

Coronavirus Vaccine: Moderna and Pfizer Final Test Results Imminent

Moderna should have enough data from its late-stage trial to know whether its coronavirus vaccine works in November, CEO Stephane Bancel said Thursday. The company could have enough data by October, but that’s unlikely, Bancel said during an interview on CNBC’s “Squawk Box.

If the infection rate in the country were to slow down in the next weeks, it could potentially be pushed out in a worst-case scenario in December,” he added.

Moderna is one of three drugmakers backed by the U.S. in late-stage testing for a potential vaccine. The other two are companies Pfizer and AstraZeneca.

Moderna‘s experimental vaccine contains genetic material called messenger RNA, or mRNA, which scientists hope provokes the immune system to fight the virus. In July, the company released early-stage data that showed its potential vaccine generated a promising immune response in a small group of patients.

Bancel’s comment came four days after the CEO of Pfizer said its vaccine could be distributed to Americans before the end of the year. CEO Albert Bourla told CBS’ “Face the Nation” that the company should have key data from its late-stage trial for the Food and Drug Administration by the end of October. If the FDA approves the vaccine, the company is prepared to distribute “hundreds of thousands of doses,” he said.

Source: https://www.cnbc.com/

First data for Moderna Covid-19 vaccine show it spurs an immune response

Moderna’s Covid-19 vaccine led patients to produce antibodies that can neutralize the novel coronavirus that causes the disease, though it caused minor side effects in many patients, according to the first published data from an early-stage trial of the experimental shot.


It certainly is a good beginning,” said Betty Diamond, director at the Feinstein Institutes for Medical Research.

The results were published Tuesday in the New England Journal of Medicine. Moderna had previously released some results in a press release, but many experts said they were not sufficient to draw many conclusions. Even now, many are withholding judgment. The study, which was run by the National Institutes of Health, showed that volunteers who received the vaccine made more neutralizing antibodies than have been seen in most patients who have recovered from Covid-19. But a second injection, four weeks after the first, was required before the vaccine produced a dramatic immune response.

https://www.statnews.com/