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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 regime – Kariko 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.
Just over 1 million people in the U.S. have received their first dose of the coronavirus vaccine as of Wednesday morning, a far cry from the federal government’s goal of inoculating 20 million Americans by the end of the year.
Now that two Covid-19 vaccines have been approved for emergency use, the biggest hurdle to the pandemic in the U.S. is getting the doses to the roughly 331 million Americans across the country. The Centers for Disease Control and Prevention said 1,008,025 shots had been administered as of Wednesday at 9 a.m. ET.
It requires not only manufacturing of more than 600 million doses of the two-shot vaccine, but also transporting it to all corners of the country, making it accessible to Americans of all stripes, and persuading them it’s safe.
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.
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‘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.
China in recent months has been injecting hundreds of thousands of people with three preliminary coronavirus vaccines that are being tested for safety and efficacy. While the world awaits a proven drug to fight the pandemic, at least three vaccine candidates have been given to front-line medical professionals, staff of state-owned companies, and government officials since July under an emergency use program approved by Beijing.
China National Biotec Group (CNBG), a subsidiary of state-owned Sinopharm, has administered two experimental vaccine candidates to around 350,000 people outside its clinical trials, CNBG chairman Yang Xiaoming said recently. The company also donated 200,000 doses of one of the candidate vaccines that is still undergoing clinical trials in Wuhan, where the pandemic was first reported.
Another drugmaker, Sinovac Biotech, has injected 90% of its employees and their family members, or about 3,000 people, Yin Weidong, the company’s CEO, said this month.
“At present, tens of thousands of people in Beijing should have been vaccinated with Sinovac’s vaccine,” Yin told Chinese state media. Separately, Beijing also gave approval in June for members of the armed forces to receive an experimental vaccine developed by CanSino Biologics, a biopharmaceutical company that is backed by the military.
Under China’s law, vaccines developed for major public health emergencies can be deployed for urgent use if the National Medical Products Administration considers that the benefits of the treatment outweigh the risks.
Chinese manufacturers have been bullish about development, with companies Sinovac Biotech and Sinopharm even putting their vaccine candidates on display at a trade fair in Beijing this month. A China-developed coronavirus vaccine could be ready for the public as early as November, a Chinese official has told state television, as the global race to clear the final round of trials heats up.
Representatives of the firms told AFP that they hope their vaccines will be approved after phase 3 trials as early as year-end.
And on late Monday, the chief biosafety expert at the Chinese Centre for Disease Control told state broadcaster CCTV that a vaccine would be available to the general public “around November or December.”
Russian scientists have published the first report on their coronavirus vaccine, saying early tests showed signs of an immune response.
The report published by medical journal The Lancet said every participant developed antibodies to fight the virus and had no serious side effects. Russia licensed the vaccine for local use in August, the first country to do so and before data had been published.
Experts say the trials were too small to prove effectiveness and safety. But Moscow has hailed the results as an answer to critics. Some Western experts have raised concerns about the speed of Russia’s work, suggesting that researchers might be cutting corners.
Last month, President Vladimir Putin said the vaccine had passed all the required checks and that one of his own daughters had been given it. Two trials of the vaccine, named Sputnik-V, were conducted between June and July, The Lancet paper said. Each involved 38 healthy volunteers who were given a dose of the vaccine and then a booster vaccine three weeks later.
The participants – aged between 18 and 60 – were monitored for 42 days and all of them developed antibodies within three weeks. Among the most common side effects were headaches and joint pain. The trials were open label and not randomised, meaning there was no placebo and the volunteers were aware they were receiving the vaccine.
China National Biotec Group (CNBG) has won approval to run a large-scale “Phase 3” clinical trial of its novel coronavirus vaccine candidate in the United Arab Emirates (UAE), the company said on Tuesday. China is seeking to trial potential vaccines overseas because of a lack of new patients at home.
Over a dozen experimental vaccines are being trialled around the world. None of them has yet successfully completed a late-stage “Phase 3” test to determine efficacy in shielding healthy people from the virus, which has killed over 470,000 people around the world. Such trials involve thousands of participants and normally take place in countries where the virus is widespread, so that the vaccine can be observed in a real-life environment.
However, China, the origin of the global pandemic, reported fewer than 10 new local cases a day on average last month, and its researchers are now looking abroad. CNBG announced the move in a Weibo social media post, without naming the vaccine to be tested in the UAE. Units of CNBG, an affiliate of the state-owned China National Pharmaceutical Group (Sinopharm), have developed two potential vaccines, which have together been given to over 2,000 people in previous tests in China.
Other Chinese companies seeking to trial vaccines overseas include Clover Biopharmaceuticals, whose shots have been given to participants in Australia in an early study, and Sinovac Biotech (SVA.O), which is expected to begin a Phase 3 trial in Brazil with 9,000 volunteers.
Morgan Stanley, which recently named Moderna Inc (NASDAQ: MRNA) as one of the likeliest candidates to succeed in the coronavirus vaccine race, reviewed the interim Phase 1 data released by the company Monday. The Moderna Analyst Matthew Harrison maintained an Overweight rating on Moderna shares and increased the price target from $37 to $90.
Moderna’s ability to scale coupled with promising early results positions it well to compete in the market, Harrison said in a Wednesday note. The analyst expects Moderna to sell about 1.5 billion doses of the vaccine during the pandemic period and 150 million annual doses during the endemic period.
“Given the promising early results, we risk-adjust our estimates assuming a 65% probability of success, slightly higher than the ~56% of typical PhII vaccine candidates.”
Breaking down Morgan Stanley’s valuation model, Harrison said $23 of the firm’s price target increase is attributable to the coronavirus vaccine. $12 per share is assigned to year-end 2021 cash and lower dilution; $11 per share is attributed to the higher chance of success across the vaccine platform and $7 is for the increase in platform value, the analyst said. Morgan Stanley expects full Phase 1 data to be available by the time the Phase 3 study starts in July, and projects the Phase 2 data will be released in the fall of 2020.
Interim Phase 3 data is likely to be available as early as the end of the year, Harrison said.