POST 00411E : NEEDLE-FREE INJECTOR FOR MASS IMMUNIZATION CAMPAIGN
Follow-up on Posts 00405E and 00408E
16 January 2002
_________________________________________________________________
Bruce G. Weniger (mailto:[email protected] ) of the National Immunization
Program at the Centers for Disease Control and Prevention (CDC) offers us a
very documented opinion on the needle-free injector.
____________________________________________________________________________
This is feedback invited in follow-up to the posting about FDA's recent
510(k) "premarket notification clearance" for the BI-3M needle-free jet
injector manufactured by the Chemical Automatics Design Bureau
(www.fas.org/spp/civil/russia/kbkha.htm and
http://www.inspacemedia.com/english/info/industrylinks/2001/006.shtml)
in collaboration with Felton Medical International (www.feltonmedical.com/)
and PATH
(www.path.org/technos/ht_measles_elim_inject.htm).
"Clearance" of an injector device under the 510(k) route is far less
strenuous than an FDA "premarket approval" for a device (see:
http://www.fda.gov/cdrh/devadvice/3122.html#link_4). The former permits U.S. sales
solely on the basis of being "substantially equivalent" to an existing
legally-marketed predicate device
(www.fda.gov/cdrh/devadvice/314.html#contents). But the presumed predicate
device -- the multiple-use-nozzle Ped-O-Jet® -- aroused concern in the
mid-1990s from a Brazilian study which detected blood in in-vitro ejectates
collected during routine vaccination campaigns of humans
(www.aegis.org/pubs/aidsline/1994/dec/m94c3258.html). In 1997, it was
withdrawn voluntarily from the market by its manufacturer (Keystone
Industries, Inc.) because of liability fears, leading to a U.S. Department
of Defense recall from military use (see:
http://www.cdc.gov/nip/dev/jetinject.htm#policies).
Multiple-use-nozzle injectors have undergone published (Hoffman et al,
Vaccine 2001;19:4020-4027) and unpublished safety evaluation model testing
in cows, pigs, and humans in the UK, US, and Brazil. The method assays for
picoliter concentrations of blood (>20 pL/mL), which is theoretically
capable of transmitting hepatitis B infection, based on one titration study
in an HBsAg-carrier chimpanzee. The sensitivity, specificity, and relevance
to humans for these evaluations remain unvalidated. Nevertheless, for all
devices studied to date, blood was detected at levels within reliable
segments of their calibration standard curves in one or more ejectates
collected during series of up to approximately 100 in vivo injections.
The recent 510-k clearance of the BI-3m should not be interpreted to
represent a "clean bill of health" for this multiple-use-nozzle device. It
simply means the FDA considers it to be equivalent to a Ped-O-Jet® in
efficacy and safety. >From FDA's regulatory perspective, Ped-O-Jets are
still legally marketable in the U.S. WHO currently recommends that the
Ped-O-Jet® and similar devices NOT be used until their safety is
demonstrated (www.who.int/vaccines-documents/DocsPDF/www9665.pdf).
In contrast, an FDA "pre-market approval" -- for which the BI-3M was not
submitted and did not receive -- would require a much more rigorous
demonstration of both efficacy (which is not in any doubt) AND safety
(www.fda.gov/cdrh/devadvice/316.html#contents). In granting its
"clearance", the FDA made no thorough assessment of the safety of the
device with regard to the potential for transmission of bloodborne
pathogens between consecutive vaccinees.
Given the cloud of concern surrounding multiple-use-nozzle jet injectors,
the public health vaccination community should insist that all
multiple-use-nozzle injector devices undergo careful regulatory scrutiny,
i.e., a full "pre-market approval" by the FDA, or an equivalent process in
other countries. Also, the full studies of their safety and efficacy in
support of approval should be published in peer-reviewed journals, and thus
permit the public health agencies and organizations likely to use them to
make their own judgements based on the evidence.
Bruce G. Weniger
Assistant Chief for Vaccine Development
Vaccine Safety and Development Branch
National Immunization Program
Centers for Disease Control and Prevention
------------------------------------------
Postal Mail: 1600 Clifton Road (E-61)
Atlanta, GA 30333 USA
Couriers: 12 Corporate Boulevard
Atlanta, GA 30329 USA
------------------------------------------
Tel: [+1] 404-639-8779
Fax: [+1] 404-639-8834
[email protected]
http://www.cdc.gov/nip/dev
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