Pfizer-BioNTech begin Omicron vaccine trial

Pfizer and BioNTech have begun enrollment for a clinical trial to test the safety and immune response of their Omicron-specific Covid-19 vaccine in adults aged up to 55, the companies announced in a statement. The pharmaceutical giant could be ready to file for regulatory approval of the shot by March.

The company’s head of vaccine research Kathrin Jansen underscored that current data showed that boosters against the original Covid strain continued to protect against severe outcomes with Omicron. Still she recognizes the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future.”

This study is part of our science-based approach to develop a variant-based vaccine that achieves a similar level of protection against Omicron as it did with earlier variants but longer duration of protection.”

The trial will involve 1,420 people aged 18-55. It did not include people older than 55 because the goal of the study was to examine the immune response of participants dosed, rather than estimate vaccine efficacy. The trial is taking place across the United States and South Africa, and the first participant was dosed in North Carolina. The volunteers are split into three groups. The first involves people who previously received two doses of the current Pfizer-BioNTech vaccine 90-180 days prior to enrollment, and will receive one or two doses of the Omicron vaccine. The second will be people who got three doses of the current vaccine 90-180 days prior to the study and will receive either another dose of the original shot or an Omicron-specific vaccine. The third and final group are people who have never previously received a Covid vaccine, and will receive three doses of the Omicron-specific vaccine.

The Pfizer-BioNTech vaccine was the first Covid shot to be authorized in the West, in December 2020.

Source: https://www.france24.com/

Omicron: two doses of Pfizer offer 70% protection against hospitalisation

Pfizer-BioNTech’s COVID-19 vaccine has been less effective in South Africa at keeping people infected with the virus out of hospital since the Omicron variant emerged last month, a real-world study published on Tuesday showed.

Between Nov. 15 and Dec. 7, people who had received two doses of the shot had a 70% chance of avoiding hospitalisation, down from 93% during the previous wave of Delta infections, the study showed. When it came to avoiding infection altogether, the study by South Africa’s largest private health insurance administrator, Discovery Health, showed that protection against catching COVID-19 had slumped to 33% from 80% previously.

The findings from the real-world analysis are some of the first about the protection vaccines offer against Omicron outside of laboratory studies, which have so far shown a reduced ability to neutralise the virus.

Source: https://www.reuters.com/

Two Studies Assess Pfizer’s Effectiveness Against Omicron

The Omicron variant substantially reduced antibody levels generated by the Pfizer-BioNTech COVID-19 vaccine, according to preliminary results from a South African study that’s still awaiting peer review. These are the first laboratory results to see how a COVID-19 vaccine holds up to Omicron. A team of researchers led by Africa Health Research Institute‘s Alex Sigal tested 14 blood samples from 12 people against a live sample of the Omicron variant. All 12 people were vaccinated, and six were previously infected.

Overall, the scientists found a roughly 40-fold reduction in the levels of neutralizing antibodies, the virus-fighting proteins that play a key role in our immune response, compared with the original version of the virus. Omicron did not evade vaccine protection completely, Sigal wrote on Twitter, meaning there’s still benefit to being vaccinated against this new variant. But the marked reduction in antibodies raises questions of how durable vaccine protection will be against Omicron – namely, whether booster shots will sufficiently ward off disease or if new vaccines may eventually be required. Sigal called it a “very large drop in neutralization of Omicron.”

A good booster probably would decrease your chance of infection, especially severe infection leading to more severe disease,” Sigal said in an online presentation of his results on Tuesday, according to Bloomberg. “People who haven’t had a booster should get one, and people who have been previously infected should be vaccinated.”

Shortly after Sigal announced his team’s results, another group of researchers at Sweden‘s Karolinska Institutet disclosed their own findings that suggested a substantial but less dramatic decline in antibody levels. The Karolinska team found a seven-fold reduction across 17 blood samples. They noted the impact of Omicron varied greatly between samples, and they used a version of Omicron that was artificially made in a lab instead of the live virus. A lead researcher for that group said the findings make Omicron “certainly worse than Delta, but, again, not as extreme as we expected.” The results are not finalized and have not been published in a medical journal. Sigal cautioned on Twitter that the findings “are likely to be adjusted as we do more experiments.”

Source: https://www.sciencealert.com/

How to Use mRNA Technology in Vaccines to Fight Cancer

Until recently, most of the world had never heard of mRNA vaccines. To combat COVID-19, the United States Food and Drug Administration issued emergency use authorization in December 2020 for mRNA vaccines developed by Pfizer-BioNTech and Moderna. While the pandemic brought mRNA vaccines into the limelight, melanoma patient Bobby Fentress had experience with mRNA technology nearly a year prior. mRNA vaccines hold promise for fighting infectious diseases beyond the SARS-CoV-2 virus, including fighting cancer. At age 68, Bobby was an early participant in a clinical trial intended to see whether a vaccine made with mRNA could destroy his cancer cells and prevent recurrence.

Bobby’s story began in 2019. He found an odd bump on his middle finger and assumed it was a wart. After his wife urged him to be seen by a dermatologist, he received a call that he would need a biopsy – which ultimately revealed that he had stage 2c melanoma. Several months later, Bobby had most of his middle finger amputated and was told that there was a 50% possibility that the cancer would reoccur.  That’s when Bobby decided to enroll in a clinical trial with HCA Healthcare’s Sarah Cannon Research Institute in Nashville, Tennessee. He received his first shots of a personalized mRNA vaccine created by Moderna in April 2020. These vaccines are developed from a patient’s specific tumor DNA. The DNA of the tumor is analyzed to determine the differences between the tumor and a patient’s own cells and which proteins might elicit the best immune response. The mRNA vaccine is then developed to instruct the body to make these proteins and stimulate an immune response. Patients such as Bobby then receive a series of these vaccine treatments.

Bobby finished his year of treatment earlier this spring. While it is too early to know if the therapy will work, Bobby’s oncologist, Dr. Meredith McKean, is optimistic.  Immunotherapy has been a game changer for melanoma. With mRNA, the hope is that personalized therapy would offer additional treatment benefit above our standard treatments that we offer for patients broadly. Even for patients like Bobby that had surgery, ten years ago we wouldn’t be able to give him anything but highly toxic therapy options. It’s refreshing to offer a clinical trial like this. While the trial is not yet complete, we have enough data to be hopeful. It’s a very encouraging area that I’m excited about as a provider,” says Dr McKean, associate director of the melanoma and skin cancer research program at Sarah Cannon Research Institute.

https://hcahealthcaretoday.com/

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/

Half of Israel’s Population Will Be Vaccinated by the End of the Month

Israel‘s Health Minister Edelstein provided ministry data showing that 2,272,000 people have so far had the first of the two-shot Pfizer-BioNTech vaccine, including 550,000 who have also had their second dose. The number represents close to a quarter of Israel’s 9.3 million citizens and maintains its position as the country with the highest per capita vaccination rate in the world, according to monitoring groups.

Edelstein on Wednesday presented figures showing that over 210,000 vaccination shots were administered the day before, a new record for the country’s mass inoculation program.

Israelis recieve a Covid-19 vaccine, at a vaccination center operated by the Tel Aviv Municipality

Urging continued adherence to Health Ministry lockdown guidelines, which on Tuesday were extended until January 31, Edelstein wrote “a little more and this will be behind us.

His figures were more optimistic than numbers released by the ministry during the morning, which showed that 56,008 people had their first dose on Tuesday and another 114,769 had the second shot for a total of 170,777. It was not clear why there was a discrepancy in the numbers.

The ministry said 8,511 new cases were confirmed Tuesday, a drop of some 1,500 from the record-shattering 10,058 cases detected on Monday. The figure for Tuesday was the lowest weekday daily caseload in over a week. The positive test rate also dropped to 9.2%, having reached 10.2% on Monday.

Source: https://www.timesofisrael.com/

Norway Raises Concern Over Vaccine Jabs for the Elderly

Norway expressed increasing concern about the safety of the Pfizer Inc. vaccine on elderly people with serious underlying health conditions after raising an estimate of the number who died after receiving inoculations to 29. The latest figure adds six to the number of known fatalities in Norway, and lowers the age group thought to be affected to 75 from 80. While it’s unclear exactly when the deaths occurred, Norway has given at least one dose to about 42,000 people and focused on those considered most at risk if they contract the virus, including the elderly.

There are 13 deaths that have been assessed, and we are aware of another 16 deaths that are currently being assessed,” the agency said. All the reported deaths related to “elderly people with serious basic disorders,” it said. “Most people have experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local reactions at the injection site, and worsening of their underlying condition.”

Official reports of allergic reactions have been rare as governments rush to roll out vaccines to try to contain the global pandemic. U.S. authorities reported 21 cases of severe allergic reactions from Dec. 14-23 after administration of about 1.9 million initial doses of the Pfizer vaccine. The first Europe-wide safety report on the Pfizer-BioNTech vaccine is due to be published at the end of JanuaryUntil Friday, the vaccine produced by Pfizer and BioNTech SE was the only one available in Norway, and “all deaths are thus linked to this vaccine,” the Norwegian Medicines Agency said in a written response to Bloomberg on Saturday.

Source: https://www.bloomberg.com/