* 3 deaths in October after Prevenar vaccination
* Cause of deaths to be determined-Dutch health authority
* Suspended batch contains 110,000 doses
(Adds details on vaccine)
AMSTERDAM, Nov 5 Dutch authorities say they
have banned use of a batch of Pfizer Inc's (PFE.N) Prevenar, or
Prevnar, after three infants died within two weeks of receiving
the anti-infection vaccination.
"On average about 5 to 10 deaths are reported annually
after babies get vaccines," said a spokeswoman for the Dutch
health institute RIVM.
"We now have three cases in a short period; that is
unusual, and the reason for suspending the batch."
She said RIVM is investigating the cause of the infants'
deaths. Other batches of Prevenar, known as Prevnar in the
United States, will continue to be used.
Pfizer spokeswoman Gwen Fisher said preliminary
investigations by the company and health authorities had found
no link between the vaccinations and the deaths.
She said the company initiated the "quarantine" of the
batch, which she said contained 110,000 doses of Prevenar, used
to prevent pneumonia and related infections.
Fisher said the three infants also received two unrelated
other vaccines as part of routine immunizations.
No other Prevenar batches were suspended, and infants in
the Netherlands will continue to be vaccinated with it as part
of routine immunization, she added.
A spokesman for the European Medicines Agency in London
said its officials are working with the Dutch authorities to
find out whether there were any safety issues with the vaccine
The vaccine is one of the most widely used in the world and
generated sales for U.S. drugmaker Wyeth of $2.7 billion in
Wyeth, which has just been acquired by U.S. rival Pfizer,
had asked for the suspension of batch D66977 of Prevenar, RIVM
said in a statement.
Pfizer is awaiting U.S. approval of a new form of the
vaccine, called Prevnar 13, that would protect against
additional strains of a bacterium called streptococcus
pneumoniae that can cause an array of diseases, ranging from
ear infections to pneumonia and meningitis.
Pfizer hopes to eventually seek approval of Prevnar 13 for
adults, a new market that could ensure continued strong sales
growth of the Prevnar franchise for years to come.
In late New York Stock Exchange trading, Pfizer shares were
up 7 cents to $17.00.
(Reporting by Gilbert Kreijger, with additional reporting by
Ben Hirschler in London and Ransdell Pierson in New York;
editing by Simon Jessop, David Cowell and Gerald E. McCormick)