The Times - UK (2020-12-03)

the times | Thursday December 3 2020 1GM 9

News

The head of the medical regulator lik-

ened the task of approving the first

Covid-19 vaccine to the challenge of

scaling Everest as she dismissed the

idea that her agency’s work had been

anything but meticulous.

June Raine, chief executive of the

Medicines and Healthcare products

Regulatory Agency (MHRA), said that

a decision to begin a rolling review of

the Pfizer-Biontech jab during the sum-

mer had been critical.

“If you’re climbing a mountain, you

prepare and prepare — we started that

in June,” she said. “By the time the in-

terim results became available on No-

vember 10, we were at base camp.

“When we got the final analysis [on

November 18] we were ready for that

last sprint that takes us to today.”

Deborah Ashby, director of the

School of Public Health at Imperial

College, said that the MHRA was used

Regulator denies it gave jab approval too quickly

to moving at great pace when the safety

of an existing drug was in doubt. “When

it becomes apparent that drugs are

causing nasty events, they will assess

data very quickly indeed,” she said.

“Their processes are well rehearsed.”

Executives from Pfizer said that the

MHRA had been remarkably respon-

sive, sometimes requesting follow-up

data or asking further questions within

minutes of receiving information.

Penny Ward, professor in pharma-

ceutical medicine at King’s College

London, said the MHRA was more

nimble than its EU equivalent, the

European Medicines Agency (EMA).

“Unlike the EMA, they can ask ques-

tions as they go and obtain responses

faster as a single agency,” she said.

American scientists welcomed the

UK approval as a sign that the vaccine

was safe, although it is likely to re-

inforce President Trump’s frustration

at his own regulators’ slower progress.

Craig Spencer, director of global

health at Columbia University, said

that the MHRA green light was “really

heartening news” that would allay the

fears of some Americans who believed

that Mr Trump was exerting inordinate

pressure on the Food and Drug Admin-

istration (FDA), America’s regulator, to

approve a vaccine before it was ready.

“It’s good to know that another agen-

cy has looked at the information,

looked at the data and determined that

it is safe,” Dr Spencer said.

Mr Trump has repeatedly expressed

his frustration with the FDA, which he

had tried to pressure to approve a vac-

cine before the election.

Stephen Hahn, its commissioner, re-

sisted demands to loosen the emer-

gency approvals process. He was sum-

moned to the White House on Tuesday

to explain why the Pfizer vaccine had

not been approved.

When news of the meeting emerged,

Dr Hahn said: “Let me be clear: our

career scientists have to make the deci-

sion and they will take the time that’s

needed to make the right call.”

Rhys Blakely Science Correspondent

Henry Zeffman Washington

He’s the stand-out star of the Covid-

19 press briefings, acclaimed as the

government’s most effective

communicator. Jonathan Van-Tam

has won hearts and minds with his

courteous but deadly put-downs,

folksy references and elaborate

metaphors. It was natural therefore

to give the deputy chief medical

officer for England a turn at last

night’s briefing.

Professor Van-Tam turned to the

back catalogue to explain to the

country the next stage of the

vaccine programme. “I gave you the

train analogy many weeks ago now.

The train has now slowed down

safely. It has now stopped in the

station. And the doors have opened

— that was the authorisation by the

MHRA,” he said.

“What we need now is for people

to get on that train and travel safely

to their destinations... there will be

trains that come behind it, and that

is all going to take time.”

The medic suffered something of

a shunt, however, when Boris

Johnson reprimanded him for

suggesting that mask-wearing and

hand sanitising might remain part

of everyday life far into the future.

“Maybe... we may want to get

back to life as pretty much as close

to normal,” Mr Johnson said.

Or as “JVT” might have put it —

post-pandemic Britain will “tear the

pants out of it” as soon as possible.

Return ticket for Van-Tam

Francis Elliott Political Editor

News

thanks to Brexit, say ministers

Wednesday” predicted

by some (Andrew Ellson,

Will Humphries, Neil

Johnston and Charlotte

Wace write).

There were queues

outside some Primark

and Debenhams shops in

the biggest cities but

visitor numbers overall

were still significantly

down on the same day

last year.

One in four pubs

opened as the industry

issued a strong rebuke to

the government for

imposing “ridiculous”

restrictions that require

almost all venues to

serve a “substantial

meal” with drinks.

Nearly 40,

hospitality venues are

unable to open because

they are in areas under

Tier 3 restrictions. Tens

of thousands more in

Tier 2 areas decided it

was not financially

viable to welcome

customers back.

Data from

Springboard, a retail

research company,

suggested that the

number of shoppers

venturing out yesterday

was down more than a

quarter on the same day

last year. In central

London it was nearly two

thirds lower. The

analysis showed that

customers were more

likely to return to retail

parks than high streets.

Nonetheless bargain

hunters did show up in

big numbers at some

stores. At lunchtime

Debenhams’ flagship

shop on Oxford Street

had to stop customers

entering because the

store was too full. The

242-year-old retailer is

offering a fire sale of up

to 70 per cent off after

falling into liquidation

on Tuesday, putting

12,000 jobs at risk.

One shop assistant

said she was devastated

by the news. “I only got

my job in March so it’s

been an incredibly tough

year.”

Down the road,

Selfridges was far from

busy. An assistant on one

make-up counter said:

“It’s quieter than we

expected and nowhere

near as busy as this time

last year.”

Gyms, hairdressers

and golf courses also

welcomed customers for

the first time since the

beginning of last month,

when Boris Johnson

introduced the second

lockdown. Some gyms

opened at midnight,

while others had

haircuts at 1am. Most

reported brisk trade.

However, pub bosses

warned that the tougher

restrictions imposed on

their businesses meant

many would never

reopen. Emma

McClarkin, of the British

Beer & Pub Association,

said: “For those pubs

that are reopening, some

fear they could close

again as soon as this

week because they

expect trade to be so

low. Having invested

£500 million in safety

measures to ensure they

are Covid secure, it is

ridiculous so many of

our pubs are being

forced to remain closed.”

Some celebrated the end

of lockdown with a sunrise

swim at Charlton lido,

southeast London. Others

went for a haircut or

shopping on Oxford Street

VICTORIA JONES/PA; ADAM GERRARD/MIRRORPIX; GEORGE CRACKNELL WRIGHT/LNP