Saturday 01 Nov 2014

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Vaccine manufacturing capacity to increase, FDA announces prior to flu season

Published: 10:17 am CDT, June 20, 2014

The Food and Drug Administration has approved a new, U.S.-manufactured flu vaccine, which is expected to increase the domestic capacity for making shots by 50 million doses.

Health officials have been looking to increase flu vaccine manufacturing in the U.S. since most of the shots are made in other countries. The announcement on June 17 is expected to give the FDA increased oversight over quality and quantities of the vaccine, which is recommended for heart and stroke patients.

The approval is a first for the FDA, according to Robin Robinson, Ph.D., director of the Biomedical Advanced Research and Development Authority and deputy assistant secretary for preparedness and response.

“Our nation reached a milestone in battling influenza, with the U.S. Food and Drug Administration’s first approval to manufacture seasonal influenza vaccine using cell-based technology in a U.S. facility. That facility, owned by Novartis of Basel, Switzerland, and located in Holly Springs, N.C., now can manufacture cell-based vaccine against seasonal as well as pandemic influenza viruses. This new capability demonstrates the effectiveness of a multi-use approach to emergency preparedness,” she said in a released statement on the approval.

The vaccine, called FluCelVax, is made using dog cells cultured in a lab. The technology is expected to cut down response time in the case of an emerging health threat to weeks instead of months, Novartis told NBC News.

Vaccinations for flu are recommended annually before flu season starts, which varies each year. Seasonal flu activity can begin as early as October and continue to occur as late as May. While all children and adults should be immunized, vaccinations are particularly important for people living with a chronic condition like heart disease and stroke.

The flu can cause serious complications such as bacterial pneumonia or worsening of chronic heart problems, especially in those with an already weakened immune system.

According to the most-recent data available from the U.S. Centers for Disease Control and Prevention, among adults hospitalized with the flu during the 2010-2011 influenza season, heart disease was the most commonly-occurring chronic condition; 37 percent of adults hospitalized with flu during the 2010-2011 flu season had heart disease. In addition, studies have shown that influenza is associated with an increase of heart attacks and stroke.

Other vaccinations for those with chronic conditions include pneumococcal vaccine to prevent pneumococcal disease, which can present as pneumonia (lung infection), bacteremia (blood infection) or meningitis (infection of the covering of the brain and spinal cord).

These infections can lead to serious complications including brain damage, heart attack, hearing loss, amputations or death. Risks are heightened for people with heart disease or stroke.

More than 95 percent of pneumococcal deaths in the United States are in adults. Yet about 70 million adults at highest risk remain unvaccinated, leaving them vulnerable.

Most adults only need one or two doses of the vaccine during their lifetime – the number can vary depending on the age at which the first vaccine is given.

And shingles vaccine to prevent a painful localized skin rash often with blisters that is caused by the varicella zoster virus, the same virus that causes chickenpox. Shingles most commonly occurs in people age 50 or older.

A study published earlier this year from the United Kingdom showed that having shingles can increase the risk of heart attack and stroke. Compared to people who had not had shingles, those who had were 15 percent more likely to experience a mini-stroke and 10 percent more likely to have a heart attack.

Those who had shingles before age 40 were almost 2 ½ times more likely to have a stroke, 1 ½ times more likely to have a mini-stroke and more than 1 1/2 times more likely to have a heart attack than those who never had shingles.

Vaccines recommended for all adults, regardless of whether they have heart disease or stroke, include:

  • Tdap vaccine – This protects against tetanus, diphtheria and pertussis (whooping cough). Every adult needs this vaccine once in place of the Td booster that is recommended every 10 years.
  • HPV vaccine – This is recommended for young adults (through age 26 for females and 21 for males) to prevent infection with a virus that causes several types of cancer.       
  • Hepatitis B vaccine – This is recommended for all adults with diabetes through age 59 and others with certain risk factors.

Most adult vaccines are covered by Medicare and private insurers and are available in medical offices, pharmacies and public health departments.

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