FDA Approves First H1N1 Vaccine

In a major achievement towards vaccinating people against the H1N1 virus, yesterday the US Food and Drug Administration (FDA) approved the long anticipated new "swine flu" vaccine. The approval is for four pharmaceutical companies -- Sanofi Pasteur, the vaccine division of Sanofi-Aventis (SNY - Analyst Report), Novartis Vaccines and Diagnostics Limited, the vaccine and diagnostics arm of Novartis (NVS - Snapshot Report), MedImmune LLC, a subsidiary of AstraZeneca (AZN - Analyst Report) and CSL Limited of Australia.

Another company that is in the race to produce the vaccine, GlaxoSmithKline (GSK - Analyst Report), has yet to gain approval.

The first batch of the vaccine is expected to be available in another four weeks. Although the US government has ordered 195 million doses, the Centers for Disease Control and Prevention expects about 45 million initially by mid-October. The vaccines approved are in injectable form other than that of MedImmune, which is a nasal spray vaccine.

The National Institute for Health is studying the vaccine dosage and safety. Trials on healthy adults found the vaccine to be effective (within eight to ten days) in one dose instead of the initial expectation of 2 doses. This is quite significant as more people can be vaccinated given the limited supply. However, studies with children and pregnant women continue.

We believe the approval is a big opportunity for these pharmaceutical companies. The only issue of concern is supply bottlenecks. The World Health Organization (WHO) had warned earlier that supply will be much lower than anticipated earlier. Per initial estimates from October onwards, about 94 million doses of vaccine could have been manufactured by the pharmaceutical companies, but this target has already been slashed by 50-75% due to poorer than expected yield from the virus strains.

Read the full analyst report on SNY

Read the full analyst report on NVS

Read the full analyst report on AZN

Read the full analyst report on GSK