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'Near-perfect' coronavirus vaccine could be ready for approval by October

Agencies/Berlin, Germany
Filed on September 9, 2020 | Last updated on September 9, 2020 at 06.45 am
Pfizer, biontech, coronavirus, covid-19, vaccine, near perfect

(Reuters)

Pfizer and BioNTech are bidding to offer 100 million doses of their vaccine candidate, BNT162, by the end of the year.

US drug giant Pfizer and German firm BioNTech have bullishly predicted that they can have a Covid-19 vaccine available for regulatory approval by the middle of October or early November, BioNTech CEO and co-founder Ugur Sahin told CNN on Tuesday.

"It has an excellent profile and I consider this vaccine ... near perfect, and which has a near-perfect profile," Sahin said in an exclusive interview with CNN.

Pfizer and BioNTech are bidding to offer 100 million doses of their vaccine candidate, BNT162, by the end of the year, and up to 1.3 billion doses in 2021.

In July, US Department of Health and Human Services and Department of Defense confirmed a $1.95 billion (Dh7.16 billion) agreement with Pfizer to produce 100 million doses of a Covid-19 vaccine. The US Government can procure an extra 500 million doses of the vaccine as part of the agreement.

Sahin told CNN that he thinks regulatory approval for the vaccine will be provided quickly given that it's showing up well in trials.

He said the candidate had elicited strong antibody responses in both young adults and the elderly, with few side effects.

"Yes, we believe that we have a safe product and we believe that we will be able to show efficacy," he said. "We don't see frequent fever. So only a minor proportion of participants in this trial have fever. We see also much lower symptoms like headache or like feeling tired.

"And the symptoms that are observed with such vaccines are temporary, they are usually observed for one or two days and then are gone."

US President Donald Trump has suggested America could secure a coronavirus vaccine by October.

Trump told a media briefing at the White House on Monday that the US would have a "wonderful vaccine" very soon, making "the people of the world very happy".

"We will end the pandemic under Operation Warp Speed," he said.

"We have pioneered ground-breaking therapies and reduced the fatality rate by 85 per cent since April. Under my leadership, we will produce a vaccine in record time. 

"Joe Biden and his new liberal running mate [Kamala Harris] will destroy this country and would destroy the economy, and should immediately apologise for their anti-vaccine rhetoric that they are talking right now.

"This vaccine could have taken two to three years but instead it is going to be done in a very short period of time, and we could even have it during the month of October."The vaccine will be very safe and very effective. The people of the world will be very happy."

More than 150 potential vaccines are being developed and tested globally to stop the Covid-19 pandemic, with 34 in human trials, according to the World Health Organization.

Russia's vaccine, which was granted approval in the country last month, produced antibody response in all participants in early-stage trials, according to results published by The Lancet.

Meanwhile, public health officials have expressed doubt that adequate data on vaccine safety and effectiveness would be available before November. They also worry if Americans stay away from the vaccine because they don't trust it, Covid-19 will be harder to control.

The pledge announced on Tuesday was signed by the chief executive officers of American drugmakers Johnson & Johnson, Merck, Moderna, Novavax and Pfizer, and European companies AstraZeneca, BioNTech, GlaxoSmithKline and Sanofi. BioNTech has partnered with Pfizer on one of the three vaccines now in the final round of human testing.

The companies said they will seek approval or authorisation for emergency use only after they have confirmed the vaccines work and are safe through a large, final round of human testing.

"We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which Covid-19 vaccines are evaluated and may ultimately be approved," the pledge states.

The CEOs also promised to "ensure a sufficient supply and range of vaccine options, including those suitable for global access." The statement noted the nine companies previously created more than 70 new vaccines against deadly diseases, helping to eradicate some of them.

The executives likely worry that scepticism about the their medicines could limit sales, given an AP-NORC poll in May found that only about half of those surveyed planned to get the vaccine. The country already has a small, but vocal, group of "anti-vaxxers" who oppose giving their children the many standard vaccines.

The FDA's credibility also has been shaken by its emergency authorisations - at the urging of the Trump administration - for two unproven treatments, convalescent plasma and malaria drug hydroxychloroquine. Both were heavily criticised by many medical experts.


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