In this month’s Bulletin we cover two pieces of news about the flu vaccine. One looks to the future of flu shots and the other examines the low rates of vaccination in the United States.
Then we resume the saga of Evenity (romosozumab), the new osteoporosis drug that Amgen and UCB have been developing and testing for several years. With this new turn of events, it is closer than it has ever been to receiving FDA approval, but not without controversy.
Universal Flu Vaccine In Development
Researchers have identified immune cells called killer T cells that they hope will allow them to create the first ever universal, one-shot flu vaccine. The discovery was made by University of Melbourne Ph.D. student Marios Koutsakos of the Doherty Institute.
The existing method of developing influenza vaccines is consistently ineffective, usually because the most common strains of the virus each year do not match the strains for which the vaccine was created. Researchers believe that a universal vaccine would solve this by protecting against any strain of flu.
“Influenza viruses continuously mutate to evade recognition by our immune system, and they are vastly diverse, making it nearly impossible to predict and vaccinate against the strain that will cause the next influenza pandemic,” Mr. Koutsakos said.
“We have identified the parts of the virus that are shared across all flu strains, and sub-strains capable of infecting humans, and then investigated if we could find robust responses to those viral parts in healthy humans, and influenza-infected adults and children.”
University of Melbourne Professor Katherine Kedzierska, study leader and laboratory head at the Doherty Institute, said this was an exciting discovery that clearly revealed killer T cells provide unprecedented immunity across all flu viruses, a key component of a potential universal vaccine.
“Influenza B immunology particularly has remained largely understudied because it doesn’t have pandemic potential. However, it is a serious virus that can lead to death and severe illness, mostly in children, and was one of the missing pieces of the universal flu protection puzzle,” Professor Kedzierska said.
The team now has a patent on the discoveries, which will enable them to develop a universal influenza vaccine approach to reduce the impact of pandemic and seasonal influenza around the world.”1
As that development process continues, more studies and information will emerge about just how effective this new approach might be, and what the potential side-effects will be for such a vaccine.
Researchers have identified a type of immune cell capable of fighting all influenza viruses, paving the way for the development of a universal flu vaccine.
More Than 40% Of Americans Reject Flu Vaccine
A survey conducted by the National Opinion Research Center at the University of Chicago in November of 2018 found that 41% of Americans had not gotten the flu vaccine and had no intention of getting vaccinated.
”People under the age of 45 were the least likely to report being vaccinated. The top three reasons why they didn’t want the shot were: bad side effects; thinking they’ll get the flu from the shot; or thinking it doesn’t work.
Some think the side effects are worse than the flu itself, but that’s just a myth. Usually the only side effect is a sore arm.
It’s also a myth that getting the vaccine gives you the flu. The flu vaccine is inactive and cannot cause the infection. If you do get sick after getting the vaccine, it’s just a coincidence.
And while it is true that the vaccine doesn’t work 100 percent of the time, the benefit is that it lessens the severity. If you do still get the flu you’re 60 percent less likely to need treatment.”2
Aside from their toxicity and treacherous potential side effects, flu vaccines, like all drugs, are acidifying. To counteract acidification and restore pH-balance, the body pulls alkalizing minerals from bone, decreasing bone mineral density. There are many natural, bone-healthy ways to boost your immunity and protect yourself from the flu. The Save Institute recommends against getting a flu shot and instead encourages an immune-boosting diet and regular exercise.
A survey conducted in November of 2018 found that 41% of Americans had no intention of getting a flu shot, citing concerns over side effects and efficacy.
FDA Panel Recommends Approval Of Evenity (Romosozumab), Despite Serious Cardiovascular (And Many Other) Risks
An FDA advisory committee has recommended Evenity (romosozumab) for approval in an 18-1 vote, concluding that the drug’s benefits outweigh its risks for treating osteoporosis in postmenopausal women at high risk for fracture.
This comes after the FDA rejected the drug’s initial application, submitted by developer Amgen in partnership with UCB in 2017 after concerns about cardiovascular (CV) risks. The current application was resubmitted a year later and has a proposal to include a boxed warning that will list potential CV safety risks. The developer also agreed to complete a post-approval observational study assessing the effects of those risks.
Evenity could have been on the market last year but the FDA rejected it because of an unexpected cardiac safety signal in one of the phase 3 studies in Amgen’s dossier.
Amgen, which developed the drug in partnership with Belgium’s UCB, has come back with new data, and a request for approval in a narrower indication of women with osteoporosis at high risk of fracture, instead of in the population of all postmenopausal women.
This could limit its commercial prospects, and there is no guarantee that the FDA will approve Evenity (romosozumab) as decisions of its advisory committees are not binding.
Nevertheless 18 out of 19 of the experts from the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) voted in favour of approval.
The BRUDAC reviewed data from the phase 3 FRAME study, testing the drug in 7,180 postmenopausal women at risk for fracture, and ARCH, an active comparator-controlled study with 4,093 postmenopausal women with osteoporosis and with prior history of fracture.
They also reviewed data from STRUCTURE, an active comparator-controlled study with 436 postmenopausal women with osteoporosis.
It was the ARCH study that threw up the unexpected cardiovascular safety signal that has caused the problems.
But things seem to be turning in Amgen’s favour now – the Japanese regulator approved it last week and UCB has filed it in Europe, where it is also under review.
Pascal Richetta, head of bone and executive vice president at UCB, said: “Evidence suggests that many women who sustain a fragility fracture are not appropriately treated for osteoporosis. This is why new treatment options, like Evenity, are so important.”
Evenity works by inhibiting the activity of sclerostin, which enables the body to increase bone formation and reduce bone resorption simultaneously.
Amgen sees Evenity as a successor to its older osteoporosis drug, Prolia (denosumab), which is nearing the end of its patent life and could face competition from cheaper biosimilars.3
Given the 18-1 vote in favor of approval, Evenity (romosozumab) may finally be about to make it to the market, Nothing about this drug has changed between the first and second application to the FDA. The risks now are just as dire as they were then.
Evenity (romosozumab) caused terrible side-effects in addition to stroke and other cardiovascular events. Trial participants experienced atypical fractures and osteonecrosis of the jaw4 but still, the advisory panel disregarded them, and recommended the drug for approval.
Like the rest of the osteoporosis drugs, Evenity (romosozumab) sclerostin alters the natural bone remodeling process, instead of supporting it naturally.
An FDA advisory committee has recommended that the agency approve the new osteoporosis drug Evenity (romosozumab), in spite of its serious medical risks.
Fortunately, Savers know that there’s no need to risk dangerous side effects caused by ineffective drugs to reverse osteoporosis and osteopenia. A natural course of action, including a pH-balanced diet and regular weight-bearing exercise, can not only increase your bone strength and resilience, but it can also improve your health and your quality of life.
Stop Worrying About Your Bone Loss
Join thousands of Savers from around the world who have reversed or prevented their bone loss naturally and scientifically with the Osteoporosis Reversal Program.
1 Doherty Institute. “‘Killer’ immune cells provide solution to elusive universal flu vaccine.” Press Release. 19 February 2019. Web. https://www.doherty.edu.au/news-events/news/killer-immune-cells-provide-solution-to-elusive-universal-flu-vaccine
2 “Over 40 percent of Americans say no to flu vaccinations.” Fox5. 11 December 2018. Web. http://www.fox5ny.com/news/over-40-percent-of-americans-say-no-to-flu-vaccinations
3 PharmaPhorum. “FDA Advisers Back Amgen/UCB’s Osteoporosis Drug Evenity.” January 17, 2019. Web. https://pharmaphorum.com/news/fda-advisers-back-amgen-ucbs-osteoporosis-drug-evenity/
4 Kolata, Gina. “Fearing Drugs’ Rare Side Effects, Millions Take Their Chances With Osteoporosis.” The New York Times. June 1, 2016. Web. http://www.nytimes.com/2016/06/02/health/osteoporosis-drugs-bones.html?_r=0