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Bloomberg Businessweek March 8, 2021said in an open letter. “The vaccine must be proven safe.”
Pfizer ruffled feathers with some inside Operation Warp
Speed. The company had been pushing for the U.S. govern-
ment to place an additional order of 100 million doses, but
OWS officials were wary. The company was already failing to
meet its production targets for November, for reasons that
were unclear, according to the former senior administra-
tion officials. Pfizer says it kept the government informed
about production.
When Pfizer announced the results of its final-stage trial six
days after the election, the news was huge: The vaccine was
more than 90% effective at preventing Covid symptoms. Slaoui
says Bourla called him right before Pfizer issued a news release
at 6:45 a.m. on Nov. 9, and he was so excited that he had to
refrain from shouting for fear of waking up other guests in his
hotel in Washington. Nevertheless, amid the euphoria was some
bad news: Pfizer warned that it would be able to produce only
50 million doses worldwide by the end of the year, instead of
the 100 million it had projected.
Pfizer was running into major production problems at its
1,300-acre campus in Kalamazoo, Mich., where the company
set up a freezer farm the size of a football field to store doses
at the required -75C (-103F). Scaling up manufacturing of a new
product with a new technology required a steady flow of raw
materials. It turned out Pfizer needed the government’s help
after all. To clear supply chain holdups, company executives
were pressing Warp Speed for an order under the Defense
Production Act, which would give it priority access to sup-
pliers. Other OWS candidates had been taking advantage of
the DPA for months. OWS hesitated. The administration offi-
cials say they were worried that Pfizer would use its size and
market clout to muscle out Moderna in the supply chain if it
got equivalent status under the DPA.
Pfizer’s production holdups had a huge impact on the U.S.
vaccine rollout. Before the trial results were announced, OWS
had been expecting 20 million doses in November and 20 mil-
lion in December. Instead it got nothing in November and
20 million doses in December, some of them flown in from
Pfizer’s production site in Belgium, to make up for the gaps
from Kalamazoo.
The U.K., which was the first country to authorize the vac-
cine, on Dec. 2, had been expecting 10 million doses by the
end of the year but got about half that. Despite the supply chal-
lenges, Pfizer announced right before Christmas that it had
agreed to supply the U.S. with another 100 million doses. At
the same time, government officials finally agreed to provide
the company with priority under the DPA.
In late December a flurry of news stories from the Middle
East revealed that Pfizer had contracted to sell millions of
doses to countries in previously unreported deals. Dubai
got its first doses flown in from Belgium and announced it
would aim to inoculate 70% of its 3.3 million people with the
Pfizer vaccine. Officials in Saudi Arabia told TV broadcaster
Al Arabiya they were expecting 3 million Pfizer doses, with a
third of those to be delivered by the end of February. Omanordered 370,000, paying $30 a shot for early supplies arriving
in December and $24 a shot for later shipments, the health
minister told a government news outlet. This appeared to be
one of the highest prices outside Israel, though lack of disclo-
sure makes it impossible to say for sure.
Pfizer executives found a partial fix to their supply problem
in the vaccine vials themselves. They just needed authoriza-
tion to change the labels to say the vials contained six doses
instead of five. It’s standard practice in the pharmaceutical
industry to overfill vials slightly to avoid running the risk of
under shooting and violating FDA labeling laws. Pfizer was
overfilling each vial by just enough for an extra dose if vacci-
nators used what are called low dead-volume syringes.
But not all vaccination sites had the syringes. Moreover, the
company’s application to the FDA and other regulators spec-
ified five-dose vials. Pfizer needed to generate data showing
the extra shot could be reliably extracted.
The company did that and then began pressing FDA offi-
cials to change the authorization to recognize the sixth dose.
OWS officials were against the change, anticipating nightmare
logistical implications right when they were starting the big-
gest mass vaccination campaign in U.S. history, the former
senior administration officials say. Pfizer’s vaccine needed
to be kept at subarctic temperatures—it was already difficult
enough to distribute without last-minute rejiggering. (Recently
the FDA announced that it can be kept at normal freezer tem-
peratures for up to two weeks.)
The company’s lobbying efforts succeeded. On Jan. 6 the
FDA revised its fact sheet, allowing the sixth dose and effec-
tively boosting Pfizer’s production by 20%. Regulators in
Europe, the U.K., and elsewhere followed suit. The U.S. and
the U.K. had managed to source the syringes, but other coun-
tries were left scrambling. Sweden and Japan complained they
didn’t have enough special syringes to extract the sixth dose
and warned it would likely mean millions of doses would be
thrown away. Austria was also short of supplies.
Bourla defended the policy change by saying the companyVACCINE POLITICS
Daily first doses administered in Italy and Israel
◼ Under 30 ◼ 30-59 ◼ 60 and overItaly Israel80k40080k400
1/10/21 2/10/21 1/10/21 2/10/21
DATA: GOVERNMENT REPORTS