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◼ REMARKS Bloomberg Businessweek November 23, 2020best. But to win this race—and save lives—every day counts.
“Yes, I could see the U.K. being first or one of the first, but
it will be entirely subject to the data that are submitted,” says
David Salisbury, Britain’s former health department director of
immunization, now at the global health program at Chatham
House, the London think tank. “The issue is clearly the start-
ing gun, which is licensing. It will depend on the data submit-
ted to the regulators, be they MHRA, EMA, or FDA, and we
mustn’t forget other regulators around the world.”
Among these gatekeepers’ most potent tools for speeding
local approvals is the so-called rolling review—a process that
allows regulators to see clinical data in real time and have dis-
cussions with companies about ongoing trials and manufac-
turing processes so that approvals can happen more quickly.
The approach is designed to speed up access to drugs and vac-
cines when there is a public health need. The EMA announced
in October that it was starting rolling reviews of the Pfizer and
AstraZeneca jabs in Europe. The British regulator then took
a similar path, with Moderna announcing that the U.K.’s drug
agency had started a rolling review, followed on Oct. 30 by a
Bloomberg News report that the MHRA was doing the same
for the Pfizer and AstraZeneca vaccines.
In Canada, the government cast a wide net in its own global
quest to protect its population, even partnering with China’s
CanSino Biologics Inc. That deal fell through in August, after
China refused to allow research to be exported to Canada amid
a separate spat over the arrest of a Huawei Technologies Co.
executive. As a result, Canada’s National Research Council
turned its focus to other partners and put the nation on track
to pick a winner on its own terms.
On Sept. 16, Canadian Minister of Health Patty Hajdu
signed an interim order that introduced a “temporary reg-
ulatory pathway” to help expedite Covid-19 drugs and vac-
cines. The Western front-runners all jumped aboard. On Oct. 1,
AstraZeneca became the first to apply for the Canadian rolling
review, followed on Oct. 9 by Pfizer and BioNTech. Three days
later, Moderna threw its hat into the ring.
In the process, Moderna, based in Cambridge, Mass.,
opened a window on another crucial part of the regulatory
maze: the production chains. Its announcement said that the
20 million doses of Moderna vaccine ordered by the Canadian
government would be sourced from its European production—
made by a Swiss partner and bottled by a Spanish one. Put
another way, the company isn’t relying on American industry
to supply the U.S.’s next-door neighbor.
Such quirks of the production chain could be determinative.
Even if vaccines soon clear hurdles of efficacy and safety, the
final push to victory relies on production, distribution, and,
again, the regulators pulling the levers.
AstraZeneca’s global production is handled by local regu-
lators whose governments are aching to inoculate their peo-
ple. In Europe, the company is using a pharmaceutical plant
near Rome owned by New Jersey-based Catalent Inc. to bottle
hundreds of millions of vaccine doses. It also has been getting
a bespoke service from the Italian pharmaceutical regulator,AIFA, according to Mario Gargiulo, the company’s global head
of biologics operations. “They are really helping us a lot,” says
Gargiulo, who has been on-site at Catalent’s Italian outpost.
A crucial step has been the preparing of documents to qual-
ify his company’s stainless-steel fill-and-finish machinery for
the bottling project. Usually, Gargiulo says, that can take six
to nine months and involves submitting all the paperwork
for approval at once, then waiting for an inspection visit. But
thanks to documentation being reviewed as it’s produced, “It’s
been a 10-times reduction,” he says. “They are much closer to
us, much faster. They are very interactive with us.”
That cooperation puts any U.K.-EU rivalry in a more com-
plicated light. In May, U.K.-Italian cooperation helped Oxford-
AstraZeneca beat the competition to the start of Phase III
trials—the first major milestone in a vaccine’s march to effi-
cacy. British regulators assisted in streamlining the process in
which thousands of doses were being produced in Italy, accord-
ing to Stefania Di Marco, the scientific director of Advent Srl,
the Pomezia, Italy-based company that produced thousands of
doses for the trials. “This was always done in a fast-track way,”
she says. “We could compress time.”
On May 20, her team sent the first batch, around 400 vials
each containing 10 doses, from Rome to London. On arrival the
next day in Oxford the vaccine batch “immediately” began a
final process of approvals based on a book-size document pre-
pared by the Italian team, Di Marco says—“it was given prior-
ity.” Seven days later, on May 28, a member of the Oxford group
authorized as a qualified inspector by the MHRA released
the doses for use. That evening, the Oxford team started the
Phase III trial—putting it weeks ahead of the competition, at
least until the September pause.
Shrinking the timeline further in the bottling operation,
the Italian regulator has been exchanging documents and data
with the EMA, meaning that multiple processes are happening
in parallel rather than serially, speeding the ultimate goal of
releasing the vaccine to the entire continent—whether or not
Britain goes first. “AIFA is collaborating very strongly with the
EMA. We have seen that in the production process,” Gargiulo
says. “They will fast-track, as long as the vaccine is approved.
What’s at stake is public health.”
Speed is good. But speed with cooperation is better. Experts
warn that any moves by individual nations to protect their
own populations at the expense of others would actually leave
everyone vulnerable, allowing the virus to continue to spread.
“Multilateral cooperation between regulatory authori-
ties will be critical in ensuring there is a level playing field,
that Covid-19 vaccines and medicines are safe, effective, and
quality-assured, and that all countries may benefit from such
products equitably and at the same time,” the World Health
Organization said on Nov. 6 in a joint statement with the
International Coalition of Medicines Regulatory Authorities,
whose members include U.S., European, and Japanese regula-
tors. Says Hatchett of the Coalition for Epidemic Preparedness
Innovations, “I’m optimistic, but everyone has to agree to work
together.” <BW> �With Simone Preissler Iglesias