Wednesday, June 23, 2021

US vaccine trials set for October result, year-end rollout

Pfizer Inc and BioNTech say they have vaccines stockpiled and awaiting the nod from the FDA.

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The race to find an effective Covid-19 vaccine is well underway in several countries with trials of experimental vaccines now being carried out.

The chief executive of Pfizer Inc, which is teaming with German drug maker BioNTech, said it should know if its experimental Covid-19 vaccine works by the end of October.

If then approved, it could be in US pharmacies by the end of the year.

Talking to CBS News, CEO Albert Bourla said there is a “good chance” of getting key data from late-stage trials to the Food and Drug Administration (FDA) by the end of October.

“We already started manufacturing and we have stockpiled doses, so just in case we have a conclusive study result, and the FDA approves, we’ll be ready to go.”

He said Pfizer will absorb a financial loss if the vaccine fails, but he is adamant about not taking government money.

“I gave our scientists an open cheque book so that they need worry only about scientific challenges, nothing else. Also, I wanted to keep Pfizer out of politics.”

He said Pfizer has already invested about US$1.5 billion into the vaccine hunt.

“At the end of the day, it’s only money.”

On Saturday, Pfizer and BioNTech sought FDA approval to expand their vaccine trial to 44,000 participants.

Bourla told CBS, “This study has recruited very quickly. Volunteers from all over the country raised their hands to participate. We are almost done with 30,000 people, so we now want to expand the study to more vulnerable populations.”

In July, the company signed a US$1.95 billion deal with the US government to produce 100 million doses of the vaccine if it gains federal approval.

“As to who will get the vaccine, I think that’s something the authorities should decide. In the US for example, that’ll be the CDC.”

The Centers for Disease Control and Prevention is the US national public health institute.

Pfizer and BioNTech’s hunt for a vaccine is one of many vaccine hunts currently underway globally.

British-Swedish multinational pharmaceutical company AstraZeneca, headquartered in Cambridge, England, is currently running trials on its own vaccine, together with Oxford University.

On Saturday, they said they have resumed testing their vaccine after temporarily halting clinical trials worldwide last week while investigating an adverse reaction in a trial participant in the UK.

Pausing a vaccine trial is not uncommon, health experts say.

AstraZeneca is running several large trials around the world, including one in the US.

Michele Meixell, AstraZeneca spokesperson, told USA Today, “We shall continue to work with health authorities across the world, including the FDA in the US, and produce this vaccine at no profit to the company during this pandemic.”

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