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[1/2] Test tubes are seen in front of displayed Pfizer and Biontech logos in this illustration taken, May 21, 2021. Moderna first sued Pfizer in August, accusing the company of violating its rights in three patents related to innovations that Cambridge, Massachusetts-based Moderna said it pioneered before the COVID-19 pandemic. Moderna has also filed a related lawsuit against Pfizer and BioNTech in Germany. In its lawsuit, Moderna asked for an undisclosed amount of money damages from Pfizer COVID-19 vaccines sold since March. Pfizer and BioNTech said in their Monday filing that they developed their vaccine independently, calling Moderna's lawsuit "revisionist history" and arguing its patents "far exceed its actual contributions to the field."

☆ Omicron boosters are weaker against BQ.1.1 subvariant that is rising in U.S., study finds
▼ + stars: | 2022-12-06 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

Covid shots designed to protect against the omicron variant trigger a weaker immune response against the rapidly emerging BQ.1.1 subvariant than the previously dominant strain, according to a new lab study. Scientists at the University of Texas Medical Branch, in a study published online Tuesday in Nature Medicine, found that the booster shots performed well against the BA.5 subvariant they were designed to target. People with a prior history of infection who received an omicron booster, however, had a stronger response to BQ.1.1. Omicron BQ.1.1 subvariant appears on track to become the dominant variant in the U.S. Omicron BA.5, on the other hand, now represents about 14% of new infections.

☆ Pfizer rejects Moderna claim it copied Covid vaccine, accuses rival of rewriting history
▼ + stars: | 2022-12-06 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Vials with Pfizer-BioNTech and Moderna coronavirus disease (COVID-19) vaccine labels are seen in this illustration picture taken March 19, 2021. Pfizer has rejected allegations made by rival Moderna that its Covid-19 vaccine is a copy, accusing the Boston biotech company of rewriting history to lay claim to technology developed by a field of scientists over many years. Pfizer asked a federal court in Massachusetts on Monday to dismiss Moderna's lawsuit seeking monetary damages for alleged patent violations related to the Boston company's Covid vaccine. "The Moderna inventions that Pfizer and BioNTech chose to copy were foundational for the success of their vaccine," the company claimed. Pfizer and BioNTech did not copy Moderna's technology," Pfizer said in its response.

☆ Britain's health regulator backs COVID vaccine for infants from six months
▼ + stars: | 2022-12-06 | by ( ) www.reuters.com time to read: +1 min

REUTERS/Clodagh Kilcoyne/File PhotoLONDON, Dec 6 (Reuters) - Britain's health regulator on Tuesday authorised a COVID-19 vaccine for infants as young as six months, opening the door for vaccinating the country's youngest children once the UK's Joint Committee on Vaccination and Immunisation (JCVI) agrees. Whether the vaccine is eventually deployed in this age group depends on a recommendation from the JCVI, which advises UK health departments on which shots should be used as part of the national vaccination programme. The vaccine is tailored for use in this age group - it is a lower dose version than the one used in children aged five to 11 years. U.S. officials rolled out this version of the Pfizer-BioNTech shot for the same age group earlier this year. Months ago, EU regulators also endorsed the use of COVID vaccines made by Pfizer-BioNTech and Moderna (MRNA.O) for under-fives.

☆ Myocarditis after Covid vaccine low among teens and young adults, large study finds
▼ + stars: | 2022-12-05 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +4 min

The incidence of myocarditis and pericarditis after Covid vaccination is low and most patients make a full recovery, a large international study from Nationwide Children’s Hospital found. The findings confirm earlier studies that found myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the outer lining of the heart, following Covid vaccination are rare. The review included more than 800 teens and young adults who developed myocarditis and pericarditis following Covid vaccination. The heart-related conditions usually occurred within four days after the second dose of a Covid vaccine, the study found. Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins University, said he would still like to see estimates of myocarditis risk by age, gender, vaccine type and spacing between doses.

☆ Pfizer/BioNTech seek FDA authorization for updated Covid-19 vaccine for youngest kids
▼ + stars: | 2022-12-05 | by ( Jacqueline Howard | ) edition.cnn.com time to read: +2 min

CNN —Pfizer and BioNTech have submitted an application to the US Food and Drug Administration for their updated Covid-19 vaccine to be used as the third shot in the three-dose primary vaccine series for children ages 6 months through 4 years. The vaccine makers announced on Monday that if authorized for emergency use, children in that age group will still receive the original version of the Covid-19 vaccine as their first two doses and then the updated Covid-19 vaccine – formulated to target the coronavirus Omicron subvariants BA.4 and BA.5 – as the third dose. While the primary Covid-19 vaccine series for older children and adults involves receiving two doses of the Pfizer/BioNTech vaccine, a three-dose primary series has been the approach for children younger than 5. “With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization,” according to the companies’ announcement on Monday morning. There is no vaccine for RSV, but health officials have urged people to get their flu shots and updated Covid-19 boosters heading into winter.

☆ Pfizer to invest more than $2.5 bln to expand European manufacturing
▼ + stars: | 2022-12-02 | by ( Michael Erman | ) www.reuters.com time to read: +4 min

The Puurs site has played a key role in the production of COVID-19 vaccine shots Pfizer developed with its German partner BioNTech (22UAy.DE) using the messenger RNA (mRNA) technology. Output started there in late 2020 when Europe and the United States began rolling out shots to tackle the pandemic. "It is all aligned with the growth of our pipeline," Pfizer Chief Global Supply Officer Mike McDermott told Reuters. Pfizer has also been spending significantly to expand its manufacturing capacity in the United States. The New York-based drugmaker has announced plans to expand its Kalamazoo, Michigan, Rocky Mount, North Carolina, and McPherson, Kansas plants.

☆ COVID hit HIV detection in Europe, threatens eradication progress
▼ + stars: | 2022-11-30 | by ( Ajose Koilparambil | ) www.reuters.com time to read: +2 min

Hendrik Schmidt/Pool via Reuters/File PhotoLONDON, Nov 30 (Reuters) - The number of people in Europe with undiagnosed HIV has risen as testing rates fell during the COVID-19 pandemic, threatening a global goal of ending the disease by 2030, a report said. This region includes Russia and Ukraine, which have the area's highest rates of HIV infection. This setback was likely because services related to HIV, including testing, were sidelined in many European countries during the two years of the pandemic, the report found. The report used modelling to predict the number of estimated infections and compared that to testing data provided by 46 of the 53 countries in the WHO's European region. An estimated one in eight people living with HIV in that region remains undiagnosed, it found.

☆ Dr. Jha: The U.S. is ready to 'move on' from Covid if people 'keep their immunity up to date'
▼ + stars: | 2022-11-29 | by ( Renée Onque | ) www.cnbc.com time to read: +1 min

The U.S. is getting closer than ever to finally putting Covid in the rearview mirror, according to Dr. Ashish Jha. "The good news is: People can move on if they keep their immunity up to date." Currently, that means a primary series of Covid vaccines followed by a booster shot with an omicron component, according to the Centers for Disease Control and Prevention. The omicron booster shot provides a particularly strong immune response against omicron subvariants like BA.4 and BA.5, recent data from Pfizer and BioNTech shows. But Jha hopes that figure will rise in the coming weeks, as more people get flu shots and potentially knock out both vaccines simultaneously.

But it still refuses to use Western mRNA vaccines to innoculate the population more quickly. China's hesitancy to use Western vaccine technology is contributing to the mass protests against its COVID-19 restrictions. Despite that, China is still refusing to approve and distribute Western vaccines to innoculate its citizens. In lieu of the Western vaccines, which are based on mRNA, China has been relying on its own brand of jabs, which rely on inactivated, or killed, virus. Germany this week suggested China should use Western vaccines to speed up the process and protect the country from the virus, Politico reported.

☆ Omicron boosters probably aren't very effective against mild Covid illness, but will likely prevent hospitalizations, experts say
▼ + stars: | 2022-11-25 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

The new omicron Covid boosters probably aren't very effective at preventing Covid infections and mild illness, but they will likely help keep the elderly and other vulnerable groups out of the hospital this winter, experts say. For seniors, the booster was 19% effective at preventing mild illness when administered as their fourth dose, compared to the unvaccinated. It was 23% effective against mild illness when given as their fifth dose. Though the vaccine's effectiveness against mild illness was low, people who received the boosters were better off than those who did not. Moore said people at higher risk from Covid have every reason to get a booster since it modestly increases protection.

☆ Researchers test mRNA technology for universal flu vaccine
▼ + stars: | 2022-11-24 | by ( Nancy Lapid | ) www.reuters.com time to read: +3 min

It delivers tiny lipid particles containing mRNA instructions for cells to create replicas of so-called hemagglutinin proteins that appear on influenza virus surfaces. A universal vaccine would not mean an end to flu seasons, but would replace the guess work that goes into developing annual shots months ahead of flu season each year. Moderna and Pfizer both have mRNA flu vaccines in late-stage human trials, and GSK (GSK.L) and partner CureVac (5CV.DE) are testing an mRNA flu vaccine in an early-stage safety trial in humans. These vaccines are designed to defend against only four recently-circulating influenza strains but could theoretically be changed up each year. The universal flu vaccine, if successful in human trials, would not necessarily prevent infection.

☆ Fact Check-Graph of unverified data is not evidence of increased miscarriage risk with COVID vaccination
▼ + stars: | 2022-11-22 | by ( Reuters Fact Check | ) www.reuters.com time to read: +6 min

The graph image has been circulated with remarks including, “THIS IS INSANE…4070% increase in VAERS miscarriage reports from 2019 to 2021. In contrast, VAERS shows 38 miscarriage reports in 2019 with 15 reported stillbirths, for a total of 53. VAERS data is unverified, and reporting rates are known to fluctuate, influenced by a variety of factors, including media attention to a particular illness or a new vaccine. Multiple studies around the world have found no increased risk of miscarriage or stillbirths associated with COVID-19 vaccination during pregnancy. Reuters has previously fact-checked claims that COVID-19 vaccination is associated with greater risk of pregnancy loss (here), (here), (here), (here), (here).

People who got the updated booster shots after two or more shots of the original vaccine were compared to another group of people who received only two or more doses of the original vaccine. The updated booster shots performed better in preventing infections in all adult age groups, with higher vaccine efficacy seen in people who waited longer before getting the updated booster, the CDC found. He noted that studies have shown longer intervals between Covid vaccine doses can lead to higher antibody levels. Previous Covid infections may be underreported, the agency said, and low uptake of the updated boosters could have affected the results. New subvariants BQ.1.1 and BQ.1 are on the rise in the U.S., she said, and it’s unclear how the updated boosters will perform against those strains.

☆ Updated COVID vaccines offer better protection than original -U.S. study
▼ + stars: | 2022-11-22 | by ( ) www.reuters.com time to read: +2 min

Nov 22 (Reuters) - Updated COVID-19 boosters offer increased protection against new variants in people who have previously received up to four doses of the older vaccine, a real-world study in the United States showed. The study of over 360,000 people, published in Morbidity and Mortality Weekly Report, offers the first evidence that the new vaccines by Pfizer-BioNTech (PFE.N)(22UAy.DE) and Moderna (MRNA.O) provide better protection compared to the original shots. Since their introduction in September, the vaccine boosters, which contain both original and Omicron BA.4/5 coronavirus strain, provided greater benefit to younger adults aged 18-49 years that those in the older age group. The variation in effectiveness was lower, in the range of 28-31%, when the boosters were given 2-3 months apart. The authors warned that the study may not be generalizable to future variants, as the dominant variants keep changing.

☆ Pfizer says omicron booster is better against new subvariants like BQ.1.1 than old shots
▼ + stars: | 2022-11-18 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

Pfizer said its omicron booster triggers a stronger immune response against a number of emerging Covid subvariants circulating the U.S. Pfizer developed its booster against omicron BA.5 at the request of the Food and Drug Administration. Among the emerging subvariants, the omicron booster elicited the strongest immune response against BA.4.6 with antibodies 11 times higher, and the weakest response against XBB.1 with antibodies about 5 times higher. Moderna on Monday said its omicron booster induces an immune response against BQ.1.1 though the company didn't provide specifics. Pfizer and Moderna's new boosters target both omicron BA.5 and the original strain of Covid that emerged in Wuhan, China in 2019.

☆ Pfizer/BioNTech's updated COVID shot shows strong response against BQ.1.1
▼ + stars: | 2022-11-18 | by ( ) www.reuters.com time to read: +2 min

Nov 18 (Reuters) - Pfizer Inc (PFE.N) and its German partner BioNTech SE said on Friday their Omicron-tailored shot produced higher virus-neutralizing antibodies in older adults against the emerging subvariant BQ.1.1 than its original vaccine. Antibody levels against the variant rose nearly nine-fold in older adults, aged 55 and above, who received the Omicron shot compared to a roughly 2-fold increase in participants with the original shot, according to data posted on online archive bioRxiv. The variant and related BQ.1 are gaining ground in the United States, and are expected to cause a rise in cases in the winter in Europe. The companies had recently released data that showed their Omicron-tailored shot produced a strong antibody response in older adults than the original shot after one month against the BA.4/5 subvariants. Pfizer and BioNTech said the bivalent shot also produced an immune response against newer Omicron subvariants including BA.4.6, BA.2.75.2 and XBB.1.

☆ German panel recommends COVID shot only for at-risk youngsters
▼ + stars: | 2022-11-17 | by ( Ludwig Burger | ) www.reuters.com time to read: +3 min

The recommendation also covers a version of Moderna's (MRNA.O) Spikevax vaccine for the age group but that product is in short supply in Germany at the moment, the expert panel said. European regulators in October authorised a low-dose version of Pfizer-BioNTech's first-generation vaccine for children from six months to four years, when given as a three-dose series. "When there are parents that absolutely want the vaccine for their healthy children, there are no legal reason for physicians to deny them that," said STIKO's Terhardt. STIKO also reaffirmed a recommendation it issued in May for five- to 11-year-olds, saying one COVID-19 shot was enough for healthy youngsters in that age group because most of them had already had an infection. Only slightly more than 22% of five- to 11-year-old children in Germany have so far received at least one COVID shot.

LONDON, Nov 17 (Reuters) - Pharmaceutical companies could be made to disclose prices and deals agreed for any products they make to fight future pandemics, under new rules being drawn up by the World Health Organization and reviewed by Reuters. During the pandemic, many deals that governments made with pharmaceutical companies have been kept confidential, giving them little scope to hold drugmakers accountable. A spokesperson for the WHO said it was member states that were driving the current process towards a new agreement. "The process is open, transparent, and with the input from other stakeholders, including any interested stakeholders and public, able to submit comments at public consultations." The draft will be presented to them in full in a meeting on Friday, after being circulated earlier in the week.

☆ These biotech stocks look cheap — and analysts give 2 more than 100% upside
▼ + stars: | 2022-11-16 | by ( Weizhen Tan | ) www.cnbc.com time to read: +2 min

U.S. biotech stocks have been on the up recently. To identify biotech stocks that look cheap and are expected to rally looking ahead, CNBC Pro screened the iShares Biotechnology ETF on FactSet. The ETF, which tracks U.S. biotech stocks, has jumped around 10% in the past month, and risen more than 4% in the past week. Two stocks stood out as having average potential upside of more than 100%, and a buy rating from all analysts who cover them. One stock — Chimerix — had an average price target upside of 266% from analysts, 83% of whom gave it a buy rating.

Moderna’s updated Covid booster appears to increase the immune response to omicron subvariants BA.4 and BA.5, as well as another subvariant, called BQ.1.1, that's gaining ground in the United States, the company said in a release Monday. The results are based on blood samples taken from 511 adults who got the updated booster, which targets BA.4 and BA.5, along with the original coronavirus strain, in a single shot. In people who got the updated booster, neutralizing antibodies against BA.4 and BA.5 were about fivefold higher in those with a previous Covid infection and sixfold higher in those without a documented infection, the company said. Moderna also said an additional analysis of 40 people found the updated booster demonstrated “robust neutralizing activity” against the subvariant BQ.1.1, though the response wasn’t as strong as what was seen against BA.4 and BA.5. Earlier this month, Pfizer and BioNTech said their updated booster shot generated a stronger immune response against BA.4 and BA.5 compared with their original Covid vaccine.

☆ Germany's BioNTech says to set up mRNA vaccine facility in Singapore
▼ + stars: | 2022-11-14 | by ( ) www.reuters.com time to read: +1 min

[1/2] Test tubes are seen in front of a displayed Biontech logo in this illustration taken, May 21, 2021. REUTERS/Dado Ruvic/IllustrationNov 14 (Reuters) - BioNTech SE (22UAy.DE), the German biotech that developed a widely used COVID-19 vaccine with Pfizer Inc (PFE.N), acquired a manufacturing facility in Singapore, its first in Asia, the company said on Monday. The facility, bought from a Novartis (NOVN.S) unit, will be its first messenger ribonucleic acid, or mRNA, facility in Singapore and support its vaccines production for the Asia Pacific region, BioNTech said in a statement, without disclosing financial details. The aim is to eventually expand production to other drug classes such as cell therapies, said BioNTech, which also plans to set up research and manufacturing centres in Australia. The Singapore facility is expected to be fully operational by 2023 and create more than 100 jobs by 2024.

☆ Moderna's Omicron shots shows better immune response than original COVID vaccine
▼ + stars: | 2022-11-14 | by ( ) www.reuters.com time to read: +1 min

Nov 14 (Reuters) - Moderna Inc (MRNA.O) said on Monday its Omicron-tailored vaccines produced a better immune response against the BA.4/5 subvariants in a mid-to-late stage study, when given as a booster dose, compared with its original shot. Data shows that both of Moderna's Omicron-tailored shots, mRNA-1273.214 and mRNA-1273.222, produced a higher antibody response against BA.4/5 subvariants than its original shot in vaccinated and boosted adults, the company said. Moderna, however, said levels of neutralizing antibody response dropped nearly 5-fold against the emerging subvariant BQ.1.1 when compared with BA.4/5, in an analysis of about 40 participants, although the virus neutralizing activity still remained "robust". Rival Pfizer Inc (PFE.N) and its German partner, BioNTech SE , said earlier this month their Omicron-tailored shot targeting the BA.4/5 subvariants produced a strong antibody response in older adults than the original shot after one month. Reporting by Bhanvi Satija in Bengaluru; Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.

In October 2021, Da’Vion Miller was found unconscious in the bathroom of his home in Detroit a week after receiving his first dose of Pfizer's Covid vaccine. Courtesy Da’Vion MillerMiller is one of a very small group of people in the United States who have experienced myocarditis following vaccination with the Pfizer-BioNTech or the Moderna Covid vaccines based on mRNA technology. Video: CDC says waiting longer between Covid vaccine doses could reduce myocarditis risk. Cooper joined an expert advisory panel formed by Moderna to monitor its Covid vaccine safety. The Pfizer study will include people who were previously hospitalized with vaccine-associated myocarditis, and it will also follow those who were more recently diagnosed.

☆ Sanofi, GSK score late win with EU COVID booster approval
▼ + stars: | 2022-11-10 | by ( Ludwig Burger | ) www.reuters.com time to read: +3 min

The shot is based on lab-made viral proteins provided by Sanofi and an adjuvant ingredient from GSK that increases the immune response. Adapting the older protein technology chosen by Sanofi and GSK to a new virus variant requires several months longer than under the mRNA approach, which saw a breakthrough during the pandemic. Work on the shot by Sanofi and GSK, two of the world's largest vaccine makers by sales, was delayed repeatedly. The partners later pivoted to targeting the Beta variant, requiring months in additional development time. While the shot tested at the time was bivalent - meaning it was based both on original Wuhan strain of the virus and Beta - Sanofi and GSK later focused on a monovalent shot based on Beta only.

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