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There's no vaccine, says WHO chief

theforeigner

Well-known member
http://www.int.iol.co.za/index.php?set_id=1&click_id=117&art_id=nw20090715100029926C729524


There's no vaccine, says WHO chief
July 15 2009 at 10:16AM



London - The world's top health official cast doubt on Wednesday over plans to vaccinate millions of people against the "unstoppable" swine flu pandemic, saying immunisations would not be available for months.

The comments by World Health Organisation chief Margaret Chan came as Australia reported a spike in cases and Argentina dramatically upped its toll of those killed by the virus from 94 to 137 over the last three days.

Chan told the Guardian newspaper that a vaccine would not be available for several months, despite statements from health officials in Britain that the first stocks would start arriving in August.

"There's no vaccine. One should be available soon, in August. But having a vaccine available is not the same as having a vaccine that has proven safe," Chan said.
"Clinical trial data will not be available for another two to three months," she added.

With the global death toll from A(H1N1) now reaching at least 429, WHO director of vaccine research Marie-Paul Kieny had said Monday that a swine flu vaccine should be available as early as September.

Chan's comments cast doubt on plans announced by countries around the world to start vaccinating those most at risk of contracting swine flu as early as next month.

Germany said it envisioned having to order some 25 million doses of a vaccine now under development to immunise nearly a third of its population.

Australia, the Asia-Pacific region's worst-hit country, was bracing to immunise the entire population against swine flu and has already placed an advance order for 21 million courses of a vaccine.

Currently in the southern hemisphere's traditional winter flu season, Australia said its number of cases had risen to over 10 000 and warned that the real number could be much higher.

Meanwhile, Italy predicted it may have to deal with between three and four million cases of swine flu by March 2010, the country's deputy health minister Ferruccio Fazio said.

He added that by the end of this year about 8,6 million Italians would have been vaccinated against the A(H1N1) virus, with the most vulnerable and those working in the emergency services given priority.

Argentina said its death toll rose to 137, making it the worst-hit in terms of fatalities after the United States, which has 211 fatalities and 37 000 confirmed infections according to the latest tally by US health officials.

Mexico, the third worst-hit country with 124 deaths and 12 521 infections according to the latest numbers, said late Tuesday that swine flu cases were picking up in the southeast, especially in Chiapas state near Guatemala.

Health ministers from six South American countries were to meet on Wednesday to seek a coordinated response to fighting the epidemic. Argentina will host the meeting of ministers from Bolivia, Brazil, Chile, Uruguay and Paraguay.

Elsewhere on the continent, now in its winter season, Ecuador reported the disease has spread to 14 of the country's 24 provinces, with the total number of infections at 264 with three deaths.

And in Peru, about 15 000 doctors called for a nationwide protest on Wednesday to demand better prevention against swine flu, which has claimed at least five lives and infected around 2 000 people there.

"We demand addressing adequately the needs of hospitals in order to prevent further mistakes in the treatment of swine flu and to avoid more deaths," Leoncio Diaz, president of the Peruvian Medical Federation (FMP), told AFP.

A boy died in a Madrid hospital due to a medical error after his mother died from swine flu. She was Spain's first fatality from the disease. - AFP
 
Re: There's no vaccine, says WHO chief

Here is a partial summary of the WHO .pdf from the Extraordinary meeting of Sage regarding the status of the vaccine:

Candidate reassortant vaccine viruses:
A. Classical reassortment: IVR-153 & NYMC X-179 A
B. Reverse genetics: IDCDC-RG15, NIBRG-121 & CBER-RG2
C. Characterization/safety testing of the above reassortants:
* Antigenic and genetic analysis completed
* Ferret testing completed for the first 4.
* For CBER-RG2, after consulting a vaccine safety expert group, no ferret safety testing needed for this reassortant.
All above vaccine viruses are available from WHO CCs and ERLs
by 3rd Jul a total of 341 shipments made

Growth Property
Evaluation conducted jointly by ERLs and vaccine manufacturers
Yield evaluation
A. Wild type vaccine viruses:
* A/California/7/2009 - similar to normal seasonal H1N1 component in Vero-cell
B. Reassortant vaccine viruses based on evaluation conducted so far:
* NYMC X-179A has highest yield - ~ 50% of seasonal H1N1 component
* CBER-RG2, evaluated in CBER with initial result ~50% of seasonal H1N1 component
C. Manufacturers further optimizing the yield

First available pandemic vaccine reagents:
A. First available reference antigen:
* Egg-based (NYMC X-179A)
* Prepared by CSL and labelled by TGA
* 9000 vials to be filled and capped from Jul 8
* Expected distribution Jul 10-15 to requesting manufactures
B. First available reference antiserum:
* A/california/7/2009
* First lot prepared by NIBSC on Jun 24 = 2000 vials
* Limited ongoing distribution: 50 vials per ERL; 30 vials per manufacturers upon request
* Larger distribution from subsequent larger lots expected in 2-3 weeks

Subsequent expected availability of pandemic vaccine reagents
A. Reference antigen
* CBER - egg-based, 3rd week Jul
* NIBSC - cell-based and egg-based, end Jul
* NIID - egg-based, Aug-Sept
B. Reference antiserum
* CBER - end of Jul, A/California/7
* NIID and TGA - end Jul to early Aug, A/California/7

http://www.who.int/immunization/sage/4.Zhang_SAGE_vaccine_virus_reagents_-_Final.pdf
 
Re: There's no vaccine, says WHO chief

what about the swine-vaccine ?
We could give it to humans, or not
 
Re: There's no vaccine, says WHO chief

Novartis received vax-orders from USA of worth $1B
It is estimated that this is 80%<90% of current production capacity.
Novartis gets another big order from USA, because
they can produce vaccine quickly and in large amounts

--------------------------------------------

Bisher habe Novartis von der US-Regierung H1N1-bezogene Bestellungen von bis zu USD 1 Mrd. erhalten. Nach den Analystenschätzungen entspreche das etwa 80 bis 90% der derzeitigen jährlichen Fertigungskapazität von Novartis. Zusätzliche Kapazitäten würden derzeit aufgebaut, diese würden aber größtenteils erst nach 2012 zur Verfügung stehen.

Novartis erhalte einen weiteren großen Auftrag von der US-Regierung, da das Unternehmen Impfstoffe schnell und in großen Mengen anfertigen könne.

-------------------------------------------

well, Novartis has many other orders to fulfil, so I'm skeptical
with the 80-90%.
Also we had been told since years, that cell-based production
can be scaled up.
Germany just ordered 50M doses, most from Novartis and thy
are reflecting to increase this
 
Re: There's no vaccine, says WHO chief

In the above link they said:
A/California/7/2009 - similar to normal seasonal H1N1 component in Vero-cell
So they can grow California in either eggs or cells (but the cell production would be 1/2 as much)?

Then the reassortment vaccines:
NYMC X-179A has highest yield - ~ 50% of seasonal H1N1 component
* CBER-RG2, evaluated in CBER with initial result ~50% of seasonal H1N
Can these both be grown either way? If so, cell-based would give 1/4 as much production?
 
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