Re: U.S. Could Have Had Many More Doses of Monkeypox Vaccine This Year, Xavier Becerra failure.

[Daily Mexican]

In article <t2ii9d$3laf0$8...@news.freedyn.de>
<governo...@gmail.com> wrote:
>
> I believe Biden is incompetent and insane. Facts speak for themselves.
>

WASHINGTON — The shortage of vaccines to combat a fast-growing
monkeypox outbreak was caused in part because the Department of
Health and Human Services failed early on to ask that bulk
stocks of the vaccine it already owned be bottled for
distribution, according to multiple administration officials
familiar with the matter.

By the time the federal government placed its orders, the
vaccine’s Denmark-based manufacturer, Bavarian Nordic, had
booked other clients and was unable to do the work for months,
officials said — even though the federal government had invested
well over $1 billion in the vaccine’s development.

The government is now distributing about 1.1 million doses, less
than a third of the 3.5 million that health officials now
estimate are needed to fight the outbreak. It does not expect
the next delivery, of half a million doses, until October. Most
of the other 5.5 million doses the United States has ordered are
not scheduled to be delivered until next year, according to the
federal health agency.

To speed up deliveries, the government is scrambling to find
another firm to take over some of the bottling, capping and
labeling of frozen bulk vaccine that is being stored in large
plastic bags at Bavarian Nordic’s headquarters outside
Copenhagen. Because that final manufacturing phase, known as
fill and finish, is highly specialized, experts estimate it will
take another company at least three months to gear up.
Negotiations are ongoing with Grand River Aseptic Manufacturing,
a Michigan factory that has helped produce Covid-19 vaccines, to
bottle 2.5 million of the doses now on order, hopefully shaving
months off the timetable, according to people familiar with the
situation.

Health and Human Services officials so miscalculated the need
that on May 23, they allowed Bavarian Nordic to deliver about
215,000 fully finished doses that the federal government had
already bought to European countries instead of holding them for
the United States.

At the time, the nation had only eight confirmed monkeypox
cases, agency officials said. And it could not have used those
doses immediately because the Food and Drug Administration had
not yet certified the plant where the vaccine, Jynneos, was
poured into vials.

But it could now. Some states are trying to stretch out doses by
giving recipients only one shot of the two-dose vaccine.
California, Illinois and New York have declared public health
emergencies. In New York City, every available slot for a
monkeypox shot is taken.

Lawrence O. Gostin, a former adviser to the Centers for Disease
Control and Prevention who has consulted with the White House
about monkeypox, said the government’s response has been hobbled
by “the same kinds of bureaucratic delays and forgetfulness and
dropping the ball that we did during the Covid pandemic.”

The obstacles to filling and finishing vials follow other
missteps that have limited vaccine supply. The United States
once had some 20 million doses in a national stockpile but
failed to replenish them as they expired, letting the supply
dwindle to almost nothing. It had 372,000 doses ready to go in
Denmark but waited weeks after the first case was identified in
mid-May before requesting the delivery of most of those doses.
Another roughly 786,000 doses were held up by an F.D.A.
inspection of the manufacturer’s new fill-and-finish plant but
have now been shipped.

The government also owns the equivalent of about 16.5 million
doses of bulk vaccine produced and stored by Bavarian Nordic.
But by the time the health agency ordered 500,000 doses worth to
be vialed on June 10, other countries with outbreaks had
submitted their own orders and the earliest delivery date was
October.

Another order for 110,000 doses for European nations soon
followed. When the United States came back with two more orders
of 2.5 million doses each on July 1 and July 15, the bulk could
only be delivered next year.

Xavier Becerra, who oversees both the C.D.C. and the Food and
Drug Administration, has been under attack for months for what
critics describe as his hands-off approach to public health
crises.Credit...Pete Marovich for The New York Times

https://www.nytimes.com/2022/08/03/us/politics/monkeypox-vaccine-
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