First, there is no urgency to act here. There already is an effective and safe vaccine-- EngerixB. Thusthere is little reason for the FDA to overrule a panel decision that no matter how you spin it clearly voted against Heplisav due to a data set insufficiently powered. If you went simply on odds, the FDA agrees with the panel 80% of the time. Why should this time be different especially given there already is a safe and effective vaccine. Second, the world of vaccinations is a highly politized world and the FDA is a political entity. There is little reason for the FDA to upset tbe apple cart, go against the panel, and then should some adverse AI event take place have to take the heat for it. The FDA will agree with panel and demand a larger trial. DVAXwill then have to raise more funds. Look for 1.50 as an entry point.
" If you went simply on odds, the FDA agrees with the panel 80% of the time. Why should this time be different especially given there already is a safe and effective vaccine."
Here are some reasons why this one is different. If you were to look at the 80% in which FDA and adcomm agreed, you would find very few split votes with a thumbs up for efficacy and a thumbs down for safety. The safety vote itself was close, 5-8. You would aslo find very few instances in which the FDA briefing document clearly leaned in a direction counter to the adcomm vote. Also, in this case, there is more middle ground available that was not contemplated in the questions proposed to the committee. In this case, two of the no votes, specifically Drs. Wharton and Gellin specified that they would be satisfied with the additional safety database expansion done post approval if the indication were narrowed to a higher risk population. Those specific comments swing the safety vote to 7-6 in favor of safety if the indication were confined to a group with a higher benefit/risk profile.
Trader are you talking to the board or these guys
FEDERATED INVESTORS INC 28,500,486
FMR LLC 26,665,314
SAC CAPITAL ADVISORS LP 10,251,200
VANGUARD GROUP INC 9,358,383
STATE STREET CORP 9,168,898
HEALTHCOR MANAGEMENT, L.P. 8,000,000
BARCLAYS GLOBAL INVESTORS UK HOLDINGS LTD 4,635,396
REDMILE GROUP, LLC 3,823,407
BLACKROCK FUND ADVISORS 3,679,792
BLAIR WILLIAM & CO/IL 3,555,825
AMERIPRISE FINANCIAL INC 3,461,579
MILLENNIUM MANAGEMENT LLC 2,636,890
NORTHERN TRUST CORP 2,635,181
LORD, ABBETT & CO. LLC 2,424,111
AYER CAPITAL MANAGEMENT, LP 2,238,543
Good point. On the other hand it's true that delaying this vaccine signs a certain number of death warrants for the hard-to-treat that wouldn't respond to current vaccines but would respond to this more efficacious one.
An interesting situation for the FDA to be in, and it's not obvious which way this'll go.
An earlier post of mine that argues the exact opposite - except with actual data - not opinion.
"Bottom Line: Encouraging FDA approval of a novel vaccine made with new technology for a flu vaccine. Realize that while this technology is not directly related to Heplisav (i.e., TLR9 agonists adjuvants), it does demonstrate FDA's willingness to approve novel vaccines made under novel conditions.
FDA NEWS RELEASE
For Immediate Release: Jan. 16, 2013
Media Inquiries: Rita Chappelle, 301-796-4672, firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA, OCOD@fda.hhs.gov
FDA approves new seasonal influenza vaccine made using novel technology
The U.S. Food and Drug Administration today announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.
Unlike current flu vaccines, Flublok does not use the influenza virus or eggs in its production. Flublok’s novel manufacturing technology allows for production of large quantities of the influenza virus protein, hemagglutinin (HA) – the active ingredient in all inactivated influenza vaccines that is essential for entry of the virus into cells in the body. The majority of antibodies that prevent influenza virus infection are directed against HA. While the technology is new to flu vaccine production, it is used to make vaccines that have been approved by the FDA to prevent other infectious diseases.
“This approval represents a technological advance in the manufacturing of an influenza vaccine,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The new technology offers the potential for faster start-up of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus.”
Each year, the FDA, World Health Organization, the Centers for Disease Control and Prevention and other public health experts collaborate on the review of influenza disease surveillance and laboratory data collected from around the world in an effort to identify strains that may cause the most illness in the upcoming season. Based on that information and on the recommendations of the FDA’s Vaccines and Related Biological Products Advisory Committee, the FDA selects the different influenza strains each year that manufacturers should include in their vaccines for the U.S. population for the upcoming influenza season. The closer the match between the circulating strains causing disease and the strains in the vaccine, the better the protection against influenza.
Flublok contains three, full-length, recombinant HA proteins to help protect against two influenza virus A strains, H1N1 and H3N2, and one influenza virus B strain.
As it does with all influenza vaccines, the FDA will evaluate Flublok annually prior to use by the public each flu season. The recombinant HA proteins produced in the baculovirus expression system and included in Flublok will be assessed by the FDA.
The effectiveness of Flublok was evaluated in a study conducted at various sites in the United States that compared the use of Flublok in about 2,300 people to a placebo that was given to a control group of similar size. Flublok was about 44.6 percent effective against all circulating influenza strains, not just the strains that matched the strains included in the vaccine.
Flublok’s safety evaluation was conducted in a study of about 2,500 people who were vaccinated with Flublok. The most commonly reported adverse events included pain at the site of injection, headache, fatigue and muscle aches, events also typical for conventional egg-based, inactivated influenza vaccines.
Flublok has a shelf life of 16 weeks from the date of manufacture. Health care providers should check the expiration date before administering Flublok.
Flublok is manufactured by Protein Sciences Corp, of Meriden, Conn. Less