In the new Phase I RSV on elderly in combination with an approved TIV. Did anyone find out who is the manufacturer of this TIV? I tried to do a brief search on this, but did not find anything concrete. Perhaps someone else was able to find it.
the elderly trial, with 220 subjects, started in mid october, shortly after the initiation of the maternal trial.
The maternal trial will have interim results in Q1... I assume March... Unless the elderly trial is more complicated to analyze, shouldn#$%$ resultes (interim) follow the maternal by weeks or a month? Thus in April..... long term results probably oct 2013...
The huge option call purchases for April (over 20,000), made in nov or dec.. might well be a signal that the elderly results will be known in April. Just a hunch.
A successful elderly trial might be a landmark even thought it's phase I.
In any case... the next three months will tell a story for Novavax. Given what we know about the RSV vaccine to date, the story will have a very happy ending.
Sentiment: Strong Buy
The elderly study is for a combo of RSV/flu, not RSV alone. It stands to reason that much more work is required to analyze and properly #$%$ the data. This study, although only phase I, is much more important than RSV phase II done on women.
The results of the latter are highly expected to be just as great as the previous study done on women. Not only are the results very predictable, but they also do not guarantee the all-important effect on kids, babies and new borns, where the real need is, and where the real money is.
The results on the elderly are much more important because:
1) They test RSV/flu combo, not only RSV. Huge revenue potential exist from RSV/flu combo for the elderly.
2) We won't be sure of the results until they come out. Don't be surprised if the results came out mediocre. The elderly have very poor immune systems.
3) If the results came out good, they would signal that the RSV vaccine could also be effective on all other groups with weakened immune system, namely kids, babies and new-borns. Don't understimate this point.
#$%$ somehow replaced an apostrophe t... I have seen this various times before and confused by its placement... took it to mean cursing... but evidently it's cause by some virus???
Sentiment: Strong Buy
Previously, I said, "NVAX didn't say. But, since Fluzone High Dose (Sanofi Pasteur) is the only one given to the elderly, I'm guessing it must be it"
I don't know what possessed to make that stupid statement. Fluzone High Dose received FDA fast-track approval for the elderly in 2009. So, how did they vaccinate the US elderly against the flu before 2009? Obviously, with regular dose flu vaccines that are used with young people. The high dose is supposed to give better protection, but it has worse side effects. The elderly can still ask for the regular flu shot, if they don't like the high dose. Obviously, everyone makes the regular dose (Sanofi and others).
Thus, I shouldn't have assumed that NVAX must have chosen Fluzone High Dose. They may have chosen the regular dose manufactured by anyone (including Sanofi Pasteur). However, if they chose Sanofi's, it's more likely that they chose the high dose.
If NVAX did the RSV/flu test in anticipation of a partnership with a particular big pharma, they would have chosen the regular dose flu vaccine of the big pharma. But, if the big pharma were Sanofi, they would have chosen Sanofi's high dose.
On the other hand, if NVAX is trying to attract any big pharma (not a particular one), then NVAX would have chosen a regular dose flu vaccine.
I say this because the high dose is still controversial.
Conclusion: No educated guess can be made about which pharma manufactures the flu vaccine NVAX is using in the RSV/flu combo test.
Thanks. So you are guessing Sanofi Pasteur?
That is quite interesting because Sanofi was one of the few that was awarded the pandemic flu preparedness contract by the US as well MedImmune, GSK, Novartis and CSL. I don't think Sanofi's pandemic flu vaccine is any good.
And since Emergent snapped up VaxInnate, the only easy game left is Novavax pandemic flu vaccine for faster response. It would not be a stretch to think Sanofi may need Novavax to fulfill the pandemic preparedness program. Novartis has its animal cell based pandemic flu vaccine, so they are unlikely.
Sanofi, GSK and MedImmune are not working on cell based vaccine, so they are still eggs...which would be very unfavorable in a pandemic flu outbreak.
I don't know, all these of these are potential partners if you ask me. Or perhaps, Stan wants to license out only the flu vaccine VLPs like VaxInnate, and then using that to fund the RSV independently.
"MedImmune is committed to conducting innovative infectious disease research to determine how best to prevent serious illness that can negatively impact pediatric health, especially during this time of year," said Alexander A. Zukiwski, M.D., executive vice president and chief medical officer. "We believe the data being presented at this meeting will help lead to important new healthcare solutions, and our company is proud to advance our already robust research base to identify the best ways to help protect children."
MedImmune abstracts to be presented at ICAAC/IDSA on RSV include:
Respiratory Syncytial Virus Therapy Utilizing Intranasally Delivered Motavizumab, a Monoclonal Antibody Against the Viral Fusion Protein (#V-4145) B. Richter, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM
BACKGROUND: A primary cause of pneumonia and bronchiolitis in young children is RSV infection. This preclinical study examined the therapeutic effect of topically administered motavizumab.
Therapeutic Addition of Motavizumab, a Monoclonal Antibody Against Respiratory Syncytial Virus, Modulates Epithelial Cell Responses to RSV Infection (#V-4146) S. Krishnan, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM
BACKGROUND: RSV infection of epithelial cells leads to inflammatory host responses. This preclinical study tested whether motavizumab, a humanized monoclonal antibody against the RSV fusion (F) protein, could modulate epithelial cell immune responses to RSV. Lower and upper airway epithelial cells were infected with RSV and motavizumab or a control antibody was subsequently administered at various points post-infection to evaluate the therapeutic addition.
Total Healthcare Costs of Preterm Infants with Medically Attended Respiratory Syncytial Virus Lower Respiratory Infection (#K-1429 ) D. Stewart, Sunday, October 26, 2008, Hall C from 12:15 PM to 1:15 PM
BACKGROUND: While RSV lower respiratory infection (LRI) is the most common cause of hospitalization among infants under one year of age, the total healthcare costs of medically attended RSV LRI for babies of this age group is unknown. This retrospective, propensity-matched cohort assessment sought to determine first-year healthcare costs by examining premature infants born over a five-year period who were insured by a national U.S. health plan, including a subgroup analysis of babies born between 33 and 36 weeks gestation.
In Vitro Mechanism of Action Studies of the RSV-Neutralizing Monoclonal Antibodies Palivizumab and Motavizumab (#V-4146) K. Huang, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM
BACKGROUND: Synagis is the only licensed drug product available to help prevent lower respiratory tract RSV infection in premature infants, a leading cause of hospitalizations in this patient population. An affinity-optimized version of Synagis, motavizumab, has been subsequently developed. Since both Synagis and motavizumab bind the RSV fusion (F) protein, which plays a role in virus attachment and mediates the process of virus-cell fusion and cell-to-cell fusion, this study aimed to determine exactly how the drugs neutralize RSV. Four assays were used, which target four distinct steps during virus replication, to identify the mechanism.
In Vitro and In Vivo Characterization of a Motavizumab-Resistant RSV A Mutant (#V-4148) F. J. Palmer-Hill, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM
BACKGROUND: This study investigated the growth characteristics - both in vitro and in vivo - of an RSV mutant that was created in the laboratory and is resistant to neutralization by motavizumab, an affinity-optimized MAb directed against the RSV fusion (F) protein. The F protein of the MAb differs from a wild type RSV F protein, so comparisons were made.
Characterization of Respiratory Syncytial Virus (RSV)Mutants Resistant to Antibody Neutralization with Novel Amino Acid Changes in the RSV Fusion Protein (#V-4149) N. K. Patel, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM
BACKGROUND: Synagis is a MAb approved for the prevention of serious lower respiratory tract RSV infection in premature infants. Motavizumab was developed by affinity optimization of Synagis and is characterized by greater in vitro and in vivo neutralization activity against RSV. Previously, the selection of RSV mutants resistant to Synagis has been reported, characterized by amino acid changes in the RSV fusion (F) protein. This study sought to identify the selection and characterization of additional Synagis MAb-resistant mutants, as well as a novel motavizumab MAb-resistant mutant.
MedImmune abstracts to be presented at ICAAC/IDSA on influenza include:
Influenza-like Illness and Employee Productivity - Results from the Child and Household Influenza-illness and Employee Function (CHIEF) (#K-4207) M. D. Rousculp, Tuesday, October 28, Room 150B from 2:450 PM to 3:00 PM
BACKGROUND: This prospective cohort study of nearly 2,293 U.S. households evaluated the effect of employee and household member influenza-like illness on worker productivity. The households studied were employees from three large Fortune 500 companies. All households included in the study had at least one child. Households were surveyed monthly throughout the 2007-2008 influenza season to determine the impact of influenza-like illness on employees' work absenteeism and decreased productivity while on the job.
Impact of Early and Late Influenza Vaccine Availability on In-Office Vaccination Opportunities (#G1-1208) R. Judelsohn, Sunday October 26, Hall C from 11:15 AM to 12:15 PM
BACKGROUND: The CDC now recommends all children from six months to 18 years of age receive an annual influenza vaccination; however, a key barrier to implementation is the inconvenience to parents and providers around scheduling additional office visits to administer the vaccination. This study examined how many more vaccination opportunities exist if influenza vaccination availability were expanded beyond the typical October-to-December timeframe.
Benefits Versus Risks of Live Attenuated Influenza Vaccine (LAIV) in Young Children (#G1-1204) G. Oster, Sunday October 26, Hall C from 11:15 AM to 12:15 PM
BACKGROUND: In September 2007, approved use of LAIV in the U.S. was expanded to include children aged 24-59 months but with warning/precautions against use in younger children and children 24-59 months with a history of recurrent wheezing or asthma. Since some latter children may receive LAIV in clinical practice, its risks and benefits versus trivalent influenza vaccine (TIV) in this setting must be considered.