Bloomberg Businessweek - USA (2021-03-01)

◼ BUSINESS Bloomberg Businessweek March 1, 2021

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Europe, the bloc now faces issues over consumer
acceptance for the doses it does have. Following a
study showing efficacy was considerably reduced
against a variant first identified in South Africa,
the rollout of Astra’s shot there was temporarily
halted. A lack of data on its effectiveness in older
adults and questions about optimal dosing inter-
vals haven’t helped.
The view of the vaccine as a lesser product is
particularly problematic given how key it is to
global immunization efforts. Astra Chief Executive
Officer Pascal Soriot has said the company plans
to make as many as 3 billion doses of the vaccine
available this year. Unlike the messenger RNA vac-
cines from Moderna and Pfizer and its German
partner BioNTech SE, which both have to be trans-
ported and stored at frozen temperatures, the
Astra-Oxford shot only needs to be refrigerated,
making it easier to distribute in less-developed
areas. Astra is also providing it at no profit during
the pandemic, and for low- and middle-income
countries in perpetuity, making it one of the most
accessible shots.
“A combination of mistakes and bad luck, com-
pounded by some unhelpful media coverage and
comments by senior politicians, have undermined
confidence in this vaccine,” says Martin McKee,
professor of European public health at the London
School of Hygiene & Tropical Medicine. “Once
trust is lost, even if unjustifiably, it’s very difficult
to  restore.”
Since Astra and Oxford announced their ini-
tial results last year, data on the vaccine’s effec-
tiveness in preventing symptomatic infection have
ranged from 60% to 90% because of different dos-
ing amounts and regimens in the trials. An analy-
sis published in February found the vaccine was
81% effective with a three-month gap between two
shots. But the European Medicines Agency puts
the efficacy at 60%, based on the trial data it used
to approve it.
Although the EMA approved the vaccine for all
adults in January, at least 10 EU countries haven’t
cleared it for use in people older than 65  because
of a lack of data for that population. French
President Emmanuel Macron called the shot
“quasi- ineffective” for people in that age group.
Responding to a lack of European confidence,
German Health Minister Jens Spahn said on Feb. 
that people who receive the Astra vaccine would
be able to get a different shot later if there were
enough supplies. As of Feb. 22, only a small frac-
tion of the almost 1.5 million Astra doses delivered
to Germany had been administered, partly fueled
by hesitancy about the shot.

U.S. data from trials of about 30,000 people

expected in the coming weeks could answer some

of the questions surrounding the vaccine. About

24% of the participants are older than 65, which

should provide sufficient information on the pro-

tection it offers older adults. Still, the trials have

been run on a four-week dosing regimen, shorter

than the 12-week gap the developers say is optimal.

An FDA decision on authorization is expected as

early as April.

The criticism started in September when global

trials of the shot were paused after a U.K. volun-

teer suffered unexplained neurological symptoms.

The British study resumed less than a week later,

but the pause stretched to almost seven weeks in

the U.S. Such events are common in trials, but the

developers were accused of a lack of transparency

over the piecemeal disclosure of information.

In November, when the partners reported ini-

tial data for the vaccine, there was more confusion.

Because of a manufacturing error, one group of

participants had received a lower first dose, which

produced an efficacy reading of 90%, compared

Vaccine Doses Distributed

As of Feb. 22

◼ Percentage of available doses administered

DATA: EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL

Germany Italy Spain

Pfizer/BioNTech 5.7m78% 3.3m84% 3.0m89%

AstraZeneca 1.5m9% 499k4% 418k15%

Moderna 336k34% 66k64% 192k64%

with 62% for those getting two standard doses.

Astra and Oxford said this produced average effi-

cacy of 70%.

Plans to run additional trials to clarify the

number were later walked back after further

analysis suggested the discrepancy could have

more to do with the dosing interval than the

amount. In January, Soriot said the company

would conduct a global study on the optimal inter-

val. A week later, Astra Executive Vice President

Mene Pangalos said the drugmaker probably

wouldn’t. Real-world data from places such as the

U.K., which has recommended a dosing gap of