Moderna sues Pfizer/BioNTech for patent infringement over COVID vaccine https://www.reuters.com/legal/moder...t-infringement-over-covid-vaccine-2022-08-26/ Aug 26 (Reuters) - Moderna sued Pfizer and its German partner BioNTech on Friday for patent infringement in the development of the first COVID-19 vaccine approved in the United States, alleging they copied technology that Moderna developed years before the pandemic. The lawsuit, which seeks undetermined monetary damages, was filed in U.S. District Court in Massachusetts. In a news release on Friday, Moderna said the lawsuit would be filed also in the Regional Court of Duesseldorf in Germany. "We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic," Moderna Chief Executive Stephane Bancel said in the news release. Moderna said its lawsuit was not meant to stop people from getting vaccines. Moderna Inc (MRNA.O), on its own, and the partnership of Pfizer Inc (PFE.N) and BioNTech SE (22UAy.DE) were two of the first groups to develop a vaccine for the novel coronavirus. Pfizer said the company was confident in its intellectual property and would vigorously defend against the allegations. "We are surprised by the litigation given the COVID-19 vaccine was based on BioNTech's proprietary mRNA technology and developed by both BioNTech and Pfizer," a Pfizer spokesperson said in an emailed statement. BioNTech did not immediately reply to separate requests for comment. Just a decade old, Moderna, based in Cambridge, Massachusetts, had been an innovator in the messenger RNA (mRNA) vaccine technology that enabled the unprecedented speed in developing the COVID-19 vaccine. An approval process that previously took years was completed in months, thanks largely to the breakthrough in mRNA vaccines, which teach human cells how to make a protein that will trigger an immune response. BioNTech had also been working in this field when it partnered with the U.S. pharma giant Pfizer. The U.S. Food and Drug Administration granted emergency use authorization for the COVID-19 vaccine first to Pfizer/BioNTech in December 2020, then one week later to Moderna. Moderna's COVID vaccine - its lone commercial product - has brought in $10.4 billion in revenue this year while Pfizer's vaccine brought in about $22 billion. Moderna is seeking royalty payments based on sales after March 8, 2022, and excluding sales to the U.S. government or to low-income countries. If it ultimately prevails, the royalty in such cases is usually a "high single digit" percentage of sales, according to Jacob Sherkow, a University of Illinois College of Law professor who specializes in biotech intellectual property issues. Wall Street analysts expect the dispute to take years. Moderna alleges Pfizer/BioNTech, without permission, copied mRNA technology that Moderna had patented between 2010 and 2016, well before COVID-19 emerged in 2019 and exploded into global consciousness in early 2020. Early in the pandemic, Moderna said it would not enforce its COVID-19 patents to help others develop their own vaccines, particularly for low- and middle-income countries. But in March 2022 Moderna said it expected companies such as Pfizer and BioNTech to respect its intellectual property rights. Jorge Contreras, a professor at the University of Utah College of Law, said that Moderna was reversing course on its public commitment that it would not enforce the patents. "You can’t just take it back because you’ve decided you'd like to make some more money," Contreras said. Sherkow said Pfizer could argue that the court should hold the company to that pledge, though added there were few if any legal precedents on whether it could be enforced. PATENT INFRINGEMENT Patent litigation is not uncommon in the early stages of new technology. Pfizer and BioNTech are already facing multiple lawsuits from other companies who say the partnership's vaccine infringes on their patents. read more In Friday's statement, Moderna said Pfizer/BioNTech appropriated two types of intellectual property. One involved an mRNA structure that Moderna says its scientists began developing in 2010 and were the first to validate in human trials in 2015. "Pfizer and BioNTech took four different vaccine candidates into clinical testing, which included options that would have steered clear of Moderna's innovative path. Pfizer and BioNTech, however, ultimately decided to proceed with a vaccine that has the same exact mRNA chemical modification to its vaccine," Moderna said. The second alleged infringement involves the coding of a full-length spike protein that Moderna says its scientists developed while creating a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS). Although the MERS vaccine never went to market, its development helped Moderna rapidly roll out its COVID-19 vaccine. Pfizer shares fell 1.3%, while BioNTech U.S.-listed shares and Moderna slipped 2% on Friday afternoon trading.
Swiss regulator grants temporary authorization for Moderna bivalent COVID booster for adults age 18 and older https://www.marketwatch.com/story/s...ooster-for-adults-age-18-and-older-2022-08-29 Moderna Inc. MRNA, -3.77% said Monday the Swiss regulator has granted temporary authorization to its bivalent omicron-targeting COVID booster for use in adults aged 18 and older. "Spikevax Bivalent Original/Omicron is a next-generation bivalent vaccine that contains 25 ug of mRNA-1273 (Spikevax) and 25 ug of a vaccine candidate targeting the Omicron variant of concern (BA.1)," the company said in a statement. Swissmedic made the decision based on data from a Phase 2/3 trial showing the booster increased neutralizing antibodies against omicron roughly 8-fold above baseline levels, it added. It also produced higher neutralizing antibody titers against BA.4 and BA.5, which has become the dominant subvariant globally, according to the World Health Organization. Moderna is working to get product to Switzerland by early September. Moderna shares were down 0.6% premarket, and have fallen 46% in the year to date, while the S&P 500 SPX, -3.37% has fallen 11%.
It will take weeks after its release to determine the effectiveness of the Omicron booster against Covid infection. The booster release -- late in the Omicron wave -- also brings up the reality about the need to more quickly create boosters against future variants. Effect of omicron-specific boosters 'remains to be seen,' vaccine experts say https://www.washingtonexaminer.com/...osters-remains-to-be-seen-vaccine-experts-say Vaccine experts say the benefits of the COVID-19 booster shots expected to be rolled out in the coming weeks remain to be seen. The Biden administration hopes that the boosters, formulated to target the prevalent subvariants of the omicron variant, willprovide better protection against infection and severe disease, but it's unclear how large an additional effect it will have given that much of the population has already been vaccinated, been exposed to the omicron variant, or both. Some experts argue that shots should've already been in arms and that, given that the virus could evolve again, authorities should focus on accelerating updated shots for future variants much more quickly. "Whether or not the new formulation ... the addition of the second spike protein to the formulation, is going to dramatically improve the protection over the original formulation, that really remains to be seen," said Lisa Morici, professor of microbiology and immunology at Tulane University School of Medicine. "It also really depends on what the virus continues to do in the population. It may mutate again, omicron BA.4 and BA.5 may fizzle out, and something else may emerge." Both Moderna and Pfizer-BioNTech submitted their booster candidates for FDA authorization earlier this week, preparing to ship doses beginning in September if approved. Half of the updated vaccine recipe targets the original strain of the virus from 2020, and the other half targets omicron subvariants BA.4 and BA.5, which now account for most COVID-19 cases in the United States. Jeremy Kamil, a virologist at LSU Health Shreveport, said the months it will have taken to get an updated booster since identifying the omicron variant last November is "unacceptable," resulting in many people getting infected with omicron and needlessly getting sick as previous vaccines proved less effective against the variant. "March 2020 to December, we had the first mRNA vaccines out; that's nine months. Now, it's going to have been 10 months between identifying omicron and simply updating a vaccine recipe,” Kamil said. “That's a total failure to the American public." Whether or not the booster cuts down on transmission rates and case numbers this fall could also be contingent on if enough people get the shot. "We need to communicate to people that this bivalent vaccine is different. It's better than the previous boosters. And we need to get the buy-in, to get a large number of people to take those boosters," said Andy Pekosz, a virologist at Johns Hopkins Bloomberg School of Public Health. "More vaccinations could mean less people that are spreading the virus, and that may mean less total number of cases." Experts underscored that the boosters, like the previous vaccines, will not eliminate breakthrough infections (meaning someone who still gets infected despite vaccination), but they will provide protection from severe illness. "The point is that you're not being hospitalized, and you're not dying of the disease," said Morici. "Every year, we get the flu vaccine, we recommend the flu vaccine — again, to prevent you from severe disease, hospitalization, and death. You might get the flu still, but your chances of ending up in the hospital are much lower. That's the same thing now that we're seeing with COVID." The Biden administration has been eager to roll out boosters in anticipation of a spike in COVID-19 cases as people head indoors during the fall and winter and has already secured agreements with Pfizer and BioNTech to purchase 171 million doses of their bivalent boosters. The government plans to offer the boosters to those who have already received the initial two-shot series, prioritizing vaccinations for those with the highest risk of developing severe COVID-19 infections, including long-term care residents and people ages 65 and older. The Pfizer-BioNTech booster is expected to be authorized for people 12 and up, while Moderna's is for those 18 and older.
FDA authorizes Pfizer and Moderna’s updated Covid-19 boosters https://www.cnn.com/2022/08/31/health/fda-covid-vaccine-updated-booster-authorized/index.html The US Food and Drug Administration on Wednesday authorized updated Covid-19 vaccine booster shots from Moderna and Pfizer. This is the first time updated Covid-19 vaccines have received emergency use authorization in the United States. Both are bivalent vaccines that combine the companies’ original vaccine with one that targets the BA.4 and BA.5 Omicron sublineages. Both companies submitted applications to the FDA for emergency use authorization for their updated vaccines last week. Pfizer’s updated vaccine is a 30-microgram dose authorized for people age 12 and older. Moderna’s updated vaccine is a 50-microgram dose authorized for people age 18 and older. The shots can be administered only after they’re recommended by the US Centers for Disease Control and Prevention. The CDC’s vaccine advisory group is scheduled to vote Thursday on whether to support recommending the boosters for use.
Individuals infected with Polio are occurring in low vaccination areas among the unvaccinated... Mainly due to the anti-vaccine campaign against all vaccines while in a Covid Pandemic. I've stated before, that we're surrounded by complete idiots on social media helping to spread their anti-vaccine message. We live in times of a very unhealthy society...mentally and physically. A lot of people don't realize that Polio often can quietly spread with no symptoms from person to person until it reaches someone that's very susceptible to the virus. Thankfully, all 50 states require (not a federal law) Polio vaccination for children to be able to enroll in the school system for many decades now. Unfortunately, if there's an outbreak of Polio...some immune compromise adults can catch Polio from a child that's been recently vaccinated with the oral vaccine for Polio. --------- Polio is the disease most people thought we had put behind us here in the United States. But earlier this summer, an individual in Rockland County, N.Y., contracted the virus likely from exposure in this country, and ended up paralyzed. The last time there was community transmission of polio in the U.S. was 1979. The Americas were declared polio free in 1994. Though it's just one case of paralysis at the moment, public health officials — both locally and nationally — are taking the news very seriously. Wastewater testing and genetic sequencing have shown the virus has been quietly circulating in a couple New York counties since at least May. And it recently was detected in New York City's wastewater. "Even a single case of paralytic polio represents a public health emergency in the United States," the Centers for Disease Control and Prevention declared in a recent report. Low vaccination rates in Rockland county mean there's a risk of more paralytic cases in that community, the report said. The challenges that health officials are facing while managing the local response in New York may indicate where other spots in the country could soon be headed... https://www.npr.org/sections/health...fight-a-polio-outbreak-among-the-unvaccinated wrbtrader
Better COVID vaccines are on the way. What do they do? And what technology might we see in future? https://theconversation.com/better-...what-technology-might-we-see-in-future-189531 Regulators in Australia and the United States last week approved Omicron-specific boosters, following approval in the United Kingdom in mid-August. In Australia, a Moderna Omicron booster has been provisionally approved for use in adults aged 18 and over. Supplies are expected to arrive in the coming weeks, however the Australian Technical Advisory Group on Immunisation (ATAGI) is yet to advise the government on how the vaccine will be used. So what’s new about the Omicron booster? And what sorts of advances in vaccine technology might we see next? Why do we need new vaccines? The current COVID vaccines will go down in history as one of the greatest achievements of medical science. Developed at record pace – without omitting any of the usual steps to ensure safety and efficacy – the vaccines significantly decreased the risk of severe disease and death. But they’re less effective at reducing infection. Frequent boosters have been required to protect against new sub-variants. This is because the spike protein, which the vaccines target, has changed. And over time, our protection has reduced due to waning immunity. What are the Omicron-specific vaccines? Most manufacturers of approved COVID vaccines began making boosters targeting previous variants as far back as Alpha. But until Omicron, these variant-specific boosters offered no significant advantage over vaccines targeting the original, or Wuhan, strain. The new Omicron boosters combine two different targets in the one vaccine, known as a bivalent vaccine. This provides broader cross-protection – against the currently circulating variants but possibly against future variants too. The first of these boosters, manufactured by Moderna, targets the BA.1 Omicron sub-variant in addition to the original or Wuhan strain. It also provides some protection against BA.4 and BA.5. This is now approved in the UK, Australia and US. The US has also approved the Pfizer bivalent booster, which targets the spike of BA.4/BA.5 as well as the original strain. What vaccine technology might we see next? Scientists are working to develop COVID vaccines that: offer longer lasting protection protect against new variants and sub-variants provide similar levels of protection from a single dose don’t require freezing or refrigeration, and that have an extended shelf life deliver a strong response from lower doses of active ingredient. More than 120 potential COVID vaccines are in clinical trials. Here are some of the improvements they’re working on. More robust protection against new variants Most vaccines approved so far target the entire spike protein. But many vaccines under development specifically target the part of the spike protein that binds to the corresponding receptor on our cells. This is less likely to change than other parts of the spike protein, delivering more robust protection against new variants. Candidate vaccines using this approach include Icosavax and one from the Serum Institute of India. Easier storage DNA-based vaccines are similar to mRNA vaccines (Pfizer and Moderna) but are more temperature-stable, making them easier to transport and store. One such vaccine, by manufacturer Zydus, has already received an emergency use authorisation in India and is injected into the skin. Another, by Inovio, is undergoing phase three trials. Greater immune responses from lower doses With current COVID vaccines, the body is given instructions to make the spike protein, or the spike protein itself is delivered. The vaccines cannot replicate or reproduce themselves. Vaccines that can replicate have the potential to generate stronger immune responses or strong enough responses from lower doses. Variant-proof vaccines Finally, many vaccines under development have the ambitious target of protecting against all coronviruses or vaccines that are essentially variant-proof. While this has not so far been achieved for any similar family of viruses, there are many promising candidates. Many rely on combining antigens from many different parts of the virus or even multiple coronaviruses. Others combine multiple receptor-binding domains (potentially allowing the vaccine to give a broader immune response against a range of variants) with other innovative technologies. Different routes of administration Current vaccines rely on administration via a needle and syringe. This is an issue for people with needle phobias, and presents challenges for the disposal of sharps. So many vaccines being developed are given via alternate routes. One way to deliver vaccines is through the nose, known as intranasal vaccination. Rather than injecting, you breathe it in. Giving the vaccine via the same route the virus gains entry has the potential to generate a response that’s better able to stop the virus entering in the first place. One of the main limitations of nasal vaccines is getting a strong enough immune response to be effective. However there are many promising candidates, including one I’m working on. Vaccines given via the skin are also a promising area. In addition to the DNA vaccines injected into the skin, others are being developed using vaccine coated onto patches, essentially made of microscopic needles. This is easier to administer. It may also have some advantages in terms of immune response and its ability to be stored at room temperature. One such vaccine that looks promising has been developed by a group originally from the University of Queensland. Finally, oral vaccines you drink are also under development. While potentially the most convenient method of administration, it’s also one that poses great challenges in terms of getting a strong enough response for the required effect. While up to five vaccines in development are exploring this avenue of administration, including one I’m involved in, they are in relatively early phases of clinical trials.
Most of the medical community and public health entities typically urge that different vaccines be given two weeks apart. This is important from the perspective of tracking adverse reactions. If you got two vaccines on the same day and had an adverse reaction then which vaccine is responsible for the adverse reaction? The one thing the White House's Covid Response Coordinator gets right is that a Covid booster is likely to be annual -- just like the flu -- for quite a while. We are at least five years away from a longer lasting Covid vaccine according to most estimates. White House wants simultaneous COVID, flu shots: ‘This is why God gave us two arms’ The remark comes as the Biden administration says COVID shots are likely to be annual https://www.foxnews.com/politics/th...e-house-suggests-simultaneous-covid-flu-shots The Biden administration on Tuesday encouraged all Americans to get an updated COVID shot as soon as possible, even if it means getting it the same day as an annual flu shot. "The good news is you can get both your flu shot and COVID shot at the same time. It's actually a good idea," said White House COVID-19 Response Coordinator Dr. Ashish Jha. "I really believe this is why God gave us two arms, one for the flu shot and the other one for the COVID shot." Jha spoke along with other members of the administration’s COVID-19 response team, including Biden’s chief medical advisor Dr. Anthony Fauci. Jha noted that the Food and Drug Administration just approved new vaccines for Americans aged 12 and up that are designed to fight the omicron variant that is now prevalent around the world. "For the first time since December of 2020, these vaccines, our vaccines, have caught up with the virus," Jha said. He added that the administration has been working over the last several days to distribute the new vaccines across the country. Fauci said that barring the appearance of some unseen new variant, most Americans should be able to receive annual COVID vaccinations, a move away from the sporadic shots and boosters that were recommended earlier in the pandemic. But Fauci did say that some "particularly vulnerable groups" of Americans may still need "more frequent vaccination against COVID-19." Jha acknowledged that it "hasn’t always been super simple" for people to understand vaccine requirements but said the newer vaccines should make life easier for most. "So, barring any new variant curveballs -- we've seen curveballs -- but barring those variant curveballs for a large majority of Americans, we are moving to a point where a single annual COVID shot should provide a high degree of protection against serious illness all year," Jha said. "That's an important milestone." Dr. Jha said the only exceptions to the administration’s recommendation for immediate vaccination are people who were recently infected or recently vaccinated. He said it’s "reasonable" for those people to wait a few months before getting a new shot.
The anti-vax crowd driving this shareholder lawsuit just got their asses handed to them by a judge who outlined everything they alleged in the suit was complete fabrications before dismissing their suit. US Judge Dismisses Shareholder Lawsuit Over AstraZeneca's COVID-19 Vaccine Disclosures: Report https://www.benzinga.com/general/bi...razenecas-covid-19-vaccine-disclosures-report Reuters reports that a U.S. judge dismissed a shareholder lawsuit claiming AstraZeneca Plc AZN concealed problems in developing its COVID-19 vaccine, making it unlikely to win FDA approval. The judge said the proposed action failed to identify any misleading statements or adequately allege that AstraZeneca intended to defraud shareholders. Shareholders said AstraZeneca stock fell in late 2020 and early 2021 as it became clear that clinical trials for its vaccine had been "hamstrung" by design and execution flaws and poor communications with regulators and the public. The shareholders said the failures included giving some participants half the designed dosages, not testing enough people over age 55, and allowing subtle differences among patient subgroups to undermine the validity of the finding. Oetken said AstraZeneca had no "generalized duty" to disclose "negative facts" about the trials. Chief Executive Pascal Soriot was not liable for saying AstraZeneca was "moving quickly but without cutting corners" and that the company was not liable for general pledges to "follow the science" and make safety a priority. "Even if defendants had access to the omitted facts, the nondisclosures here do not raise a strong inference of conscious misbehavior or recklessness," the judge wrote. Price Action: AZN shares are up 0.32% at $61.95 during the premarket session on the last check Tuesday.