Kinks In The Vaccine Pipeline

 

 

# 3895

 

The logistics of isolating a new virus, creating a seed strain that grows well, producing vaccine in quantity, getting through clinical trials, distributing it to the states, and getting it into the arms of the American public are nothing less than enormous. 

 

It was anticipated from the start that it would take 6 months to see a pandemic vaccine begin to roll off the assembly line, so the fact that we have any at all after just five months is actually an accomplishment.

 

But somewhere along the way, the decision was made to release `best-case’ estimates of how much vaccine could be made available by mid-October; an impressive (and reassuring) 120 million doses

 

And even though there were caveats provided (the proverbial `if all goes well’), officials had to know that all that people would hear was this (extremely) optimistic estimate. 

 

In August those estimates were dramatically cut to 45 million doses to be delivered by Oct. 15th.  And by October 1st, it became apparent that even that target wasn’t going to be met. 


Now, with the end of October at hand, we’ve less than 30 million doses `available’ (a nuanced point, since that doesn’t mean distributed – some of that is unshipped and in the warehouse) and suddenly the HHS finds itself in the unenviable position of having to defend what would otherwise have been perceived as a victory.

 

It is indeed regrettable that the release of overly optimistic vaccine projections three months ago should diminish the public’s perception of the work done by the HHS, and vaccine manufacturers, to get this vaccine out by October.

 

And even though more vaccine is on the way, we are a long ways from having it out and in the arms of the public. That `bumpy couple of weeks’ that the CDC warned us about in early October now looks likely to extend well into November.

 

Which may require some even more `explaining’ over the coming weeks, if people grow increasingly frustrated waiting for promised vaccines.

 

 

Maggie Fox, health & science editor for Reuters, brings us up to date on where vaccine deliveries stand, and what we know about the causes of these vaccine shortfalls.

 

Companies struggling to get H1N1 vaccine to U.S.

Tue Oct 27, 2009 3:01pm EDTBy Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) - GlaxoSmithKline has yet to get U.S. government approval for its swine flu vaccine, the company said on Tuesday, while Novartis said it was still struggling to make vaccines.

 

A U.S. senator accused the Health and Human Services department of over-promising how many and how quickly H1N1 vaccines could be delivered, as disgruntled people lined up outside clinics across the United States seeking immunization.

 

The United States has contracted with its five suppliers of seasonal influenza vaccine to also deliver H1N1 vaccine, but has sharply cut initial estimates of how much will be delivered this month and next. HHS says companies are having more trouble than anticipated making the vaccine, which is grown in chicken eggs using 50-year-old technology.

 

Glaxo, which signed a broad agreement earlier this year with HHS for $250 million of pandemic products including vaccines, says its vaccine has yet to be approved by FDA, although it submitted it in September.

(Continue. . . )

 

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