SEOUL - South Korean vaccine maker Green Cross said it has received the green light from Korea FDA to use Novartis's MF59 adjuvanted A/H1N1 vaccine for production of an A/H1N1 vaccine.

"We received the temporary approval from KFDA on Tuesday, and we will submit quality-related trial data to KFDA after we receive Novartis's adjuvant in mid-December," Green Cross spokesman Park Jun-Young told PharmAsia News. "A formal approval from KFDA is expected at the end of December."

The initial approval was given after KFDA's evaluation of the clinical trials performed on Green Cross's Green Flu-S vaccine, which is armed with the Novartis adjuvant MF59.

The new one-injection vaccine will be used for adults ages 18 to 65.

Green Cross signed a deal with Novartis to buy the adjuvanted A/H1N1 vaccine to expand its own vaccine production volume. Of Green Cross's initially planned production of 12 million doses of the A/H1N1 flu vaccines, five million doses will be produced with the adjuvant, which will increase vaccine output by up to four times, said Park, who stressed that the purchase of the Novartis adjuvant was aimed at easing lingering concerns that South Korea might suffer a shortage of flu vaccine (Also see "Novartis To Sell Flu Vaccine Adjuvant To Korea's Green Cross" - Scrip, 10 September, 2009.).

In early July, Green Cross started test production of its own A/H1N1 flu vaccine, after receiving a virus strain from the UK's National Institution for Biological Standards and Control and from the U.S. Centers for Disease Control. The company plans to market the vaccine in Korea beginning in 2010 - at the latest - after acquiring KFDA's approval (Also see "South Korea's Green Cross Begins "Test Production" of Flu Vaccine" - Scrip, 8 July, 2009.).

Flu Attention On North Korea As President Obama's Special Envoy Visits Pyongyang

Although the spread of the flu appears to be slowing down in South Korea, it could be accelerating in North Korea, prompting South Korean President Lee Myung-bak to order cabinet ministers to seek emergency aid to help North Korea against the H1N1 virus.

The flu reportedly claimed 40 lives in the impoverished North. Schools went on winter vacation a month earlier than usual because of the fast spread of the virus. The World Health Organization is reportedly looking into the possibility of an influenza A outbreak in North Korea.

"[The South Korean government] should unconditionally provide drugs to treat the influenza from a humanitarian perspective," Lee was quoted as saying during the weekly cabinet meeting by his spokesman Park Sun-kyoo in the local press.

The South Korean government said it was moving to supply antiviral drugs Tamiflu and Relenza to workers in the North's Gaesung Industrial Zone as a gesture of compassion and reconciliation between the two Koreas (Also see "South Korea Plans To Provide Tamiflu and Relenza To North Korea" - Scrip, 1 December, 2009.)

More than 40,000 North Korean workers are currently working in the zone, and South Korea has already delivered enough Tamiflu and Relenza to treat 1,000 workers.

Currently, there are no South Korean or global pharmaceutical companies doing business in the North's economic zone. Aside from distributing foreign medical aid, it is not clear how North Korea provides drugs and medical devices to its citizens.

U.S. President Barack Obama's special envoy Stephen Bosworth arrived in the North Korean capital of Pyongyang on Dec. 8 for nuclear talks with the communist regime.

In South Korea, health officials said the spread of the virus will likely lose momentum as more people are vaccinated. Students will be less likely to be infected after schools nationwide release their pupils for winter vacation later this month.

- Peter Chang (p.chang@elsevier.com)

Korea's Green Cross Gets Green Light From KFDA To Produce Novartis Adjuvanted A/H1N1 Vaccine

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