# American Big Pharma to stand against rushing COVID vaccine: sources
Source URL: 	https://www.theage.com.au/world/north-america/american-big-pharma-to-stand-against-rushing-covid-vaccine-sources-20200905-p55sol.html?ref=rss&utm_medium=rss&utm_source=rss_feed
Date: 		20200905T0300

A vaccine, which will need to be taken by millions of healthy people,
requires significant uptake to be effective in batting down the virus in
the US. One recent poll found that a majority of the public thought a
vaccine approval would be driven by politics.

Health officials inside the Trump administration have said the process
would be based entirely on science, and FDA Commissioner Stephen Hahn
has said he would not participate if he thought a vaccine were being
rubber-stamped.

At the same time, President Donald Trump has accused the agency of
slowing work to hurt him politically, and said he believed a vaccine
would be ready before election day on November 3.

At a news conference at the White House on Friday, Trump said a vaccine
could be ready "maybe even before November first" or "some time in the
month of October."

"I think you're going to see results that are shockingly good," Trump
said. It's not clear what Trump was talking about, since results of
trials are typically kept confidential while they're ongoing, with
occasional looks by a panel of experts to see if there are safety
issues, or overwhelming signs a product is working or failing.

Much of the vaccine work is being done under the umbrella of the
government's Operation Warp Speed, which has struck deals with
drugmakers to fund development and manufacturing.

Others in the administration including Moncef Slaoui, the chief adviser
for the program, have tamped down those expectations. Slaoui told
National Public Radio this week that it was "extremely unlikely" a
vaccine would be ready by election day.

In an interview with the news organisation Axios this week, Eli Lilly &
Co chief executive officer David Ricks said that most companies in the
industry wouldn't submit a COVID-19 product to the FDA until they were
confident in the science behind it. The company is developing a
treatment, but isn't among the companies party to the vaccine effort.

"Most of the principals in our industry and their scientific teams would
say we're not going to make something or we're not going to sell it
until we've proven to our own standards it's safe and effective,
subjected it to scientific scrutiny from the outside world," Ricks said.

Ricks is the head of the drug industry's lobbying group, PhRMA.

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Final-stage vaccine trials are rushing toward completion, and earlier
this week Pfizer said it could have results by October. The FDA has also
set an October 22 date for an outside group of experts to discuss a
potential vaccine.

Others associated with the industry have urged a similar strict
standard.

"I can say with complete authority that no company wants to have
anything approved but under the strictest standards, the gold standard
at the FDA," said Jim Greenwood, the former head of BIO, the trade group
representing biotechnology companies.

"It's in no biopharmaceutical company's interest to have a product
provided to patients that isn't proven to be completely safe and
effective," Greenwood said in an interview.

The head of the World Health Organisation said the UN health agency also
would not recommend any COVID-19 vaccine before it was proven safe and
effective, even as Russia and China have started using their
experimental vaccines before large studies have finished and other
countries have proposed streamlining authorisation procedures.

A technician tests samples of a potential COVID-19 vaccine at a
production plant of SinoPharm in Beijing in April.Credit:Xinhua/AP

Last week, Britain said it was preparing to revise its laws so that any
effective coronavirus vaccine could be used before it was fully
licensed.

“I would like to assure the public that WHO will not endorse a vaccine
that’s not effective and safe,” Dr Tedros Adhanom Ghebreyesus said.

Russia became the first country in the world to approve a COVID-19
vaccine in August after licensing a shot that had only been tested in
about 40 people.

On Friday, Russian scientists published data suggesting their Sputnik V
vaccine was safe and prompted an antibody response that would last "two
years or more", but the results were limited and experts said the shot
had not yet been proven to work. The vaccine is now being tested in
about 40,000 people and is offered to key workers like doctors and
teachers. Among those who have received it are one of President Vladimir
Putin's daughters and Defence Minister Sergei Shoigu.

China has reportedly begun inoculating some high-risk groups with one of
its experimental coronavirus vaccine while the large studies to prove
its efficacy and safety are ongoing. In July, the head of China's Centre
for Disease Control and Prevention announced that he had received the
shot, although he did not specify whether that was done as part of a
clinical trial.

 **Bloomberg, AP**

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