Mumps vaccine suspended in UK

Safety group concerned that materials in drug present infection risk

By Mindy Kay Bricker
Staff Writer, The Prague Post
(January 22, 2003)

What is good enough for the Czech Republic is not necessarily good enough
for the United Kingdom.

That was the message from a group of British medical officials who announced
Jan. 16 that the United Kingdom would suspend the importation of Pavivac, a
Czech-made mumps vaccine for children.

"There are a number of outstanding questions about the manufacture and
testing of the unlicensed vaccine Pavivac that are not answered by the
information currently available," said Alasdair Breckenridge, chairman of
the Committee on Safety of Medicines (CSM), an independent scientific
committee that advises the government on medicines.

The committee said it was rejecting the vaccine because kidney cells from
dogs are used to make it. The CSM said that using materials of animal origin
in humans might present a risk from unknown infections.

"There are no other vaccines in the Department of Health's vaccination
program which use this method of manufacture," reads a CSM press release.
"As a result, there are a number of additional questions not all of which
have been satisfactorily answered."

Miroslav Reinhardt, export director for Pavivac-maker Sevapharma, said the
vaccine was safe and that his company has been cooperative with UK
officials. He said the kidney cells were taken from dogs bred at farms that
follow laws regulating such practices.

"We cooperated with the Medicines Control Agency (MCA) intensely -- we
provided them with our documentation," he said, "and we hope they will
reconsider their decision."

The vaccine was not licensed for distribution in the United Kingdom. If a
medicine meets the special needs of individual patients, doctors in the
United Kingdom are allowed to obtain unlicensed drugs.

First, however, the drug must be approved by the MCA, the executive agency
of the Department of Health that ensures that all drugs meet the appropriate
standards of safety, quality and efficacy.

>From June to November, more than 5,000 doses of Pavivac were sent to the
United Kingdom. Physicians directly requested the vaccine from Sevapharma.

Pavivac first came under fire in the United Kingdom in November, when the
CSM suspended importation of the vaccine.

At the time, some British doctors criticized the action, calling the
suspension "appalling scaremongering."

When the vaccine was suspended, Czech health officials said they tried to
comply with the British government's demands for more information about

"Nothing [about the demands] was very specific or indicated that the product
was substandard," said Milan Smid, a doctor for the Czech Regulatory
Authority, the government agency that regulates drugs.

The agency reviewed the product, Smid said, and did not find any reason to
discontinue or halt production in this country.

"We didn't have any indicator to take action against the product here," he

Reinhardt said that no one who has taken the vaccine, which has been used
for 14 years, has experienced any serious adverse reactions. "More than 1.4
million children have been vaccinated with no problem," he said of the
single mumps jab used in the Czech Republic.

Smid agreed.

"Through the years of use, we had a normal spectrum of the side effects that
is comparable to other vaccines," he said. "There is no reason to take
actions against this vaccine."

United Kingdom health officials said they were unsure how many of those
doses imported into their country were administered to children.

The CSM has asked clinics to provide a record of children who received the
jab so that any adverse reactions can be quickly and thoroughly

Breckenridge said that Sevapharma provided adequate information that proved
Pavivac is effective in protecting children against mumps, as long as the
child receives a second mumps vaccine between six to 10 months after the
initial shot.

Currently, Pavivac is sold only in the Czech Republic and is not licensed in
any European Union country. The company also manufactures a single measles
vaccine, Movivac. British health officials are investigating its safety,
even though the measles vaccine has not been imported into the United

Mindy Kay Bricker's e-mail address is