11◼ REMARKS Bloomberg Businessweek November 23, 2020ILLUSTRATION BY 731
● An alphabet soup of regulators
raises the prospect of vaccine chaos● By Vernon Silver, James Paton, and
Suzi RingMaking vaccines that are safe and effective is certainly the hard
part of the race to pull humanity from the pandemic brink.
Promising results are pouring in. On Nov. 9, Pfizer Inc. and its
German partner BioNTech SE said early findings indicated their
vaccine prevented more than 90% of symptomatic infections
among volunteers. On Nov. 16, Moderna Inc. reported a 94.5%
prevention rate for its vaccine. Two days later, Pfizer-BioNTech
matched that with a final analysis of its data.
Yet if triumph in this scientific, corporate, and nationalis-
tic contest is defined as the first vaccine to get approved and
administered on a large scale, the victory is still anyone’s to
win. The final phase will require navigating the maze of reg-
ulators, scattered across continents and agencies, who will
determine when, which, and where shots of the most promis-
ing candidates will be approved, produced, and distributed.
Indeed, Pfizer-BioNTech said it would file for the first approval
of a Covid shot with the U.S. Food and Drug Administration.
These gatekeepers are an overlooked logistical reality of
the vaccine contest. This isn’t just a single race among a hand-
ful of corporate front-runners but a more fractured process in
which individual nations hold the power of approval. Yes, the
FDA is important, but the contours of a splintered final push
are already coming into focus—and they are global.
The U.K. release of the shot by AstraZeneca Plc, developed
with the University of Oxford, may well be pitted against its
European Union-approved identical twin. Canada has issued
new rules that allow its regulators to more quickly approve
a Covid-19 vaccine—and in the past few weeks, AstraZeneca,
Moderna, and Pfizer have all applied for the Canadian autho-
rization. Germans who funded the Pfizer-BioNTech jab may
want first dibs, even though President Trump has virtually
taken personal credit for it. Even New York state will have its
own vaccine vetters, according to Governor Andrew Cuomo, as
a backstop to the mistrust of the Trump administration’s FDA.
A handful of other states—including California—will follow suit.
In Brazil, the vaccine quest has turned into a multinational
regulatory soap opera. President Jair Bolsonaro’s government
has said it’s spent 2 billion reais ($369 million) to develop a vac-
cine with AstraZeneca and Oxford, which is being tested in
Brazil. At the same time in São Paulo state—run by Bolsonaro’s
rival governor, João Doria—China’s Sinovac Biotech Ltd. has
been partnering locally with the Butantan Institute, con-
ducting trials there of its CoronaVac shot. While Doria prom-
ised to deliver a vaccine to the 44 million people in his state,
Bolsonaro slammed the Chinese vaccine on safety terms “due
to its origin.” The head of the Butantan Institute complainedthat Brazil’s health agency, Anvisa, was hampering imports of
raw materials from China to produce Sinovac’s vaccine. Doria,
the São Paulo governor, snapped at Bolsonaro that denying
access to the shot “is criminal.”
The conflict hit a critical point when the national health
agency suspended Sinovac’s trials in the state after a trial sub-
ject died—without consulting the researchers and despite a
claim by the Butantan Institute that there was no link between
the death and the shot. On Nov. 11, Anvisa said it was allow-
ing Sinovac’s trial to resume, but added the next day that it’s
sending a team to China to inspect the company’s facilities.
For the pharmaceutical companies working at record speed
to save lives and the global economy, any regulatory splintering
is a distracting burden, says Richard Hatchett, chief executive
officer of the Coalition for Epidemic Preparedness Innovations,
which is funding a number of the front-runner vaccines. If
every country were to carry out its own review of a vaccine,
that would force the manufacturer to go through 190 different
regulatory processes, he says. “The requirements are largely
similar, but they’re not going to be completely aligned, and that
creates a queuing problem that is unacceptable in the context
of a pandemic,” Hatchett says.
As infections soar, deaths mount, and the coming months
promise to be a “dark winter,” in the words of U.S. President-
elect Joe Biden, nations may sprint ahead with emergency
approvals. “I really discourage this,” says Guido Rasi, who was
executive director of the European Medicines Agency (EMA) for
nine years until he stepped down on Nov. 13 to return to teach-
ing. Any speeding of the process should happen only at the
completion of clinical trials, and not in a way that fuels “vac-
cine hesitancy,” Rasi says. Undermine trust and nobody will
want your shot. Exhibit A is the risibility of Russian President
Vladimir Putin’s claim to have already won the race with a vac-
cine that hasn’t yet completed large-scale trials.
The scientific, patriotic, and bureaucratic strands of
urgency might help explain what happened after global trials
of the Oxford-AstraZeneca vaccine were halted on safety con-
cerns in early September. Within a week, U.K. regulators gave
a green light to restart them in that country. Days later, Brazil
and South Africa followed. Yet it took almost seven weeks for
U.S. regulators to allow a resumption. One apparent issue:
Bureaucracies process data differently in the EU and the U.S.,
so a lot of the information had to be made FDA-friendly. But
the upshot was clear: The U.K.’s vaccine candidate got its most
friction-free treatment at home.
In August, the U.K. signaled it would grant a temporary
authorization for an unlicensed vaccine if there was a com-
pelling case to move more quickly than the EMA, even while
the U.K. is still subject to the approval process of the EMA until
the end of the Brexit transition process on Dec. 31. U.K. health
authorities published detailed plans and legal rationales in sub-
sequent months. Could the U.K.’s Medicines and Healthcare
products Regulatory Agency give the Oxford shot the home-
town advantage with a pre-Brexit thumbs-up? With 2020
almost over, a split would be an advantage of only weeks, at