Vaccine updates: Early US approval for eventual COVID-19 shot ‘possible’

US floats idea of early approval for eventual vaccine

WASHINGTON: The head of the US Food and Drug Administration (FDA) raised the possibility in an interview published Sunday that a future vaccine against the coronavirus might be given emergency approval before the end of trials designed to ensure its safety and effectiveness.

A request for such extraordinary approval would have to come from the vaccine developer, Stephen Hahn told the Financial Times.

“If they do that before the end of Phase Three,” which involves large-scale human testing, “we may find that appropriate. We may find that inappropriate, we will make a determination.”

But Hahn insisted he was not acting under pressure from President Donald Trump, who has been pushing hard for a vaccine, saying one might be ready before US elections November 3.

“This is going to be a science, medicine, data decision,” Hahn said. “This is not going to be a political decision.”

Three Western drugs makers are well along with their Phase 3 clinical trials, involving tens of thousands of participants.

The three are AstraZeneca, which is partnering with Oxford University in England; Moderna, collaborating with the US National Institutes of Health, and the Pfizer/BioNTech alliance.

By the nature of the trials it is difficult to predict when reliable results will emerge.

Half of the participants in such trials receive an experimental vaccine, while the other half are given a placebo.

Under normal procedures, test administrators must wait – probably for months – to see whether there is a statistically significant difference in the infection rate of the two groups.

Desperately waiting

As the world desperately awaits an effective vaccine against the deadly virus, China and Russia have already approved vaccines without waiting for the conclusion of trials – drawing criticism from public health officials in other countries, including the US.

Hahn also said that an emergency authorization would not necessarily cover everyone – it might be granted for specific, high-risk groups.

“Our emergency use authorization is not the same as a full approval,” he said.

Hahn has faced mounting criticism from the medical community that he has given in to political pressure from the Trump administration, largely involving two incidents.

In March, the FDA gave emergency authorization for the use of hydroxychloroquine to treat Covid-19 after Trump repeatedly praised its use; the authorization had to be withdrawn in June after serious side effects emerged.

Outrage over optimistic appraisal

More recently, Hahn delivered a far too optimistic appraisal, during a news conference with Trump, of the effectiveness of convalescent plasma against the virus. He said it could save 35 out of 100 patients; the more likely number, experts said, is five in 100.

“It is *** outrageous to expedite *any* approval of a #SARSCoV2 vaccine, irrespective of @SteveFDA’s subservience to Trump,” Eric Topol, director of the Scripps Research Translational Institute, said on Twitter.

“We will not know about safety for many months.”

FDA chief promises transparency for vaccine review

The head of the US Food and Drug Administration (FDA) promised that the review of a potential COVID-19 vaccine in the U.S. will be transparent to the public, with any clearance by the agency driven by data alone.

In an interview, Commissioner Stephen Hahn responded to questions about the different ways the FDA could clear a vaccine for use: either under an emergency authorisation, likely based on more limited data and for use in a narrow group, or a broader approval that could lead to wider use.

“We’ve said all along we’re not going to pre-judge what mechanism we’re going to use to authorize or approve a vaccine,” Hahn told Bloomberg News by phone. “We’re going to let the data dictate that. The data will dictate what kind of decision is made on the vaccine.”

No decision on that has been made, because the agency hasn’t seen trial results yet, he said. “I don’t have a crystal ball, I don’t know what the data look like,” Hahn said.

Hahn was appointed by President Donald Trump late last year. The coronavirus, which has killed more than 180,000 Americans and infected more than 5.9 million. A vaccine is considered crucial for ending the pandemic and reviving the U.S. economy.

A vaccine is also pivotal to Trump’s re-election. The president has said a vaccine could be available by election day on November 3, and on Twitter has attacked Hahn’s agency for harboring “deep state” staff slowing vaccine and drug work to hurt him politically.

 

EU offers €400 euros to WHO-led COVID-19 vaccine initiative

 

BRUSSELS: The European Commission said it would contribute €400 million ($478 million) to an initiative led by the World Health Organization to buy COVID-19 vaccines, but did not clarify whether EU states would acquire shots through the WHO scheme.

The COVAX initiative aims to purchase for all countries in the world 2 billion doses of potential COVID-19 shots from several vaccine makers by the end of 2021.

Tedros Adhanom Ghebreyesus, WHO director-general, and Seth Berkley, head of the GAVI vaccine alliance, welcomed the financial support. “Big thanks to the @EU_Commission for their contribution to the COVAX facility and for standing firm on their commitment to multilateralism,” Tedros said in a tweet.

The EU financial support will be provided through guarantees, the Commission said on Monday. A spokeswoman for the EU executive did not clarify how these guarantees would be offered and why they were preferred to direct funding in cash.

“Today, the Commission is announcing a 400 million euro contribution to COVAX for working together in purchasing future vaccines to the benefit of low and middle income countries,” European Commission President Ursula von der Leyen said.

The EU Commission is negotiating advance purchases of COVID-19 vaccines with several drugmakers on behalf of the 27 EU states and has said in past weeks EU governments cannot buy vaccines through parallel procurement schemes.

Asked whether its guidance to EU states not to buy vaccines through COVAX was now dropped, a commission spokeswoman declined to elaborate.

“The detailed terms and conditions for the EU’s participation and contribution will be worked out in the coming days and weeks,” the Commission said.

The Commission added in a statement that it was ready, together with EU states, “to put expertise and resources at work within COVAX to accelerate and scale-up development and manufacturing of a global supply of vaccines for citizens across the world, in poor and rich countries.” Critics have said that by buying vaccines exclusively through an EU scheme, the Commission was effectively undermining the WHO-led initiative.

The Commission said it was committed to donating to developing countries some of the vaccines it buys through its procurement scheme.

The EU has promoted two global fund-raising campaigns to help develop COVID-19 vaccines and ensure equitable access. But taken aback by U.S. moves to secure potential supplies, it launched its own procurement scheme, which critics say may contribute to depriving poorer countries of doses initially. – Reuters

Canada contracts with Novavax for 76 million vaccine doses for 2021

OTTAWA: The Canadian government announced Monday a deal with American biotech firm Novavax for 76 million doses of its Covid-19 vaccine in development, if it proves to be effective against the new coronavirus.

The NVX-CoV2373 vaccine candidate, which is currently in Phase 2 clinical trials to evaluate its safety and immunogenicity, could be delivered in the second quarter of 2021, Ottawa and the company said in a joint statement.

Procurement Minister Anita Anand said the deal “will give Canadians access to a promising COVID-19 vaccine candidate.”

The deal comes as the US government granted Novavax US$1.6 billion to help fund development and manufacture of the vaccine, giving the US priority for the first 100 million doses.

Maryland-based biotech Novavax has already signed partnership or vaccine delivery agreements with Britain, Japan and India.

Canada, meanwhile, has also concluded agreements with Pfizer and Moderna for deliveries of millions of doses of their experimental vaccines, now in Phase 3 trials – among the most advanced.

Early tests showed Novavax’s vaccine candidate was “generally well-tolerated” and elicited a “robust antibody responses,” Novavax said.

“We are moving forward with clinical development of NVX-CoV2373 with a strong sense of urgency in our quest to deliver a vaccine to protect the world,” said company president Stanley Erck.

As of Monday, Canada reported nearly 128,000 cases of Covid-19 and some 9,150 deaths.

Trump says US to ‘crush’ COVID-19 with vaccine ‘this year’

WASHINGTON: US President Donald Trump on Thursday pledged to “crush” the coronavirus pandemic with a vaccine by the end of the year, as he accepted the Republican nomination for a second term.

“We are marshaling America’s scientific genius to produce a vaccine in record time,” Trump said. “We will have a safe and effective vaccine this year and together we will crush the virus.” – AFP

Optimism over vaccine, trade helped boost risk assets

Emerging-market stocks and currencies posted a weekly gain amid progress toward a coronavirus vaccine and after the US and China said they remained committed to the phase-one trade deal.

Risk assets were also given a boost after Federal Reserve Chair Jerome Powell signaled a more relaxed attitude toward inflation. A gauge of developing-nation stocks erased this year’s decline. – Bloomberg

UK to allow emergency use of any effective COVID-19 vaccine

• Britain is preparing to revise its laws to allow the emergency use of any effective coronavirus vaccine before it is fully licensed but only if the shots meet required safety and quality standards
• London adopting “safeguards” to allow the country’s medicines regulatory agency to grant temporary authorization of a COVID-19 vaccine, provided it meets safety and quality standards.

LONDON: Britain is preparing to revise its laws to allow the emergency use of any effective coronavirus vaccine before it is fully licensed — but only if the shots meet required safety and quality standards.

In a statement Friday, Prime Minister Boris Johnson’s Conservative government said it was adopting “reinforced safeguards” to allow the country’s medicines regulatory agency to grant temporary authorization of a COVID-19 vaccine, provided it meets safety and quality standards.

The proposed regulations would allow coronavirus vaccines to receive an emergency approval allowing people to be immunized while the full licensing process is being finished. Typically, vaccines are only used after the licensing review has been completed, a process which can take several months.

“If we develop effective vaccines, it’s important we make them available to patients as quickly as possible, but only once strict safety standards have been met,” Jonathan Van-Tam, Britain’s deputy chief medical officer, said in a statement.

Britain said the move was a precautionary measure” and would only be used as a last resort if there was a pressing public health justification.

Officials said they would also be expanding the number of health workers who can administer vaccines as well as clarifying the kind of protection from civil liability for this additional work force. The government is beginning a three-week consultation period to seek advice from health experts and other stakeholders. It said the measures could be introduced as early as October. – Reuters

Canada scraps COVID-19 vaccine trial with Chinese pharma company

Beijing: Canada has decided to cancel a coronavirus vaccine development agreement with the Chinese pharmaceutical company CanSino due to delay in the shipping of drugs.

According to the South China Morning Post, it is unclear if political tensions between the two countries had anything to do with the snag at the Chinese customs.

China’s National Research Council said that “The agreement between the NRC and CanSino had been reviewed prior to signature by CanSino’s collaborators in the Chinese Government – the Beijing Institute of Technology and the Ministry of Science and Technology – who had provided funding to CanSino.”

“Due to the delay in the shipment of the CanSino Covid-19 vaccine candidate doses to Canada and as CanSino has now completed phase 1 and phase 2 clinical trials elsewhere, this specific opportunity is over and the NRC is focusing its team and facilities on other Covid-19 priorities,” the council said.

The Council said it has turned to its North American partners for collaboration and will go ahead in its COVID-19 vaccine development programme. – ANI