Hackers steal vaccine data in Europe

US drugmaker Pfizer and its German partner BioNTech said on Wednesday that documents related to development of their Covid-19 vaccine had been "unlawfully accessed" in a cyberattack on Europe's medicines regulator.

The European Medicines Agency (EMA), which assesses medicines and vaccines for the European Union, said hours earlier it had been targeted in a cyberattack. It gave no further details.

Pfizer and BioNTech said they did not believe any personal data of trial participants had been compromised and EMA "has assured us that the cyber attack will have no impact on the timeline for its review."

It was not immediately clear when or how the attack took place, who was responsible or what other information may have been compromised.

The two companies said they had been informed by the EMA "that the agency has been subject to a cyber attack and that some documents relating to the regulatory submission for Pfizer and BioNTech's Covid-19 vaccine candidate" had been viewed.

Such documents could be extremely valuable to other countries and companies rushing to develop vaccines, experts said.

"When it comes to the data submitted to these kinds of regulatory bodies, we are talking confidential information about the vaccine and its mechanism of action, its efficiency, its risks & known possible side effects and any unique aspects such as handling guidelines," said Marc Rogers, founder of a volunteer group fighting Covid-related breaches, CTI-League.

"It also provides detailed information on other parties involved in the supply and distribution of the vaccine and potentially significantly increases the attack surface for the vaccine," adding more ways the formulas or production could be hacked or stolen.

The companies said "no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware that any study participants have been identified through the data being accessed."

A spokeswoman for BioNTech declined further comment. Pfizer did not respond to a request for further comment.

The Pfizer-BioNTech vaccine is a top contender in the global race to beat back Covid-19. It is already being administered in Britain.

The coronavirus has killed at least 1,570,398 people since the outbreak emerged in China last December, according to a tally from official sources compiled by AFP yesterday.

US TOPS 3,000 DAILY DEATHS

The US prepared to roll out a vaccine within days as the country's daily death toll surpassed 3,000 for the first time, exceeding the number of lives lost from the attacks of September 11, 2001.

Covid-19 deaths reached 3,253 on Wednesday, pushing up the US total since the start of the pandemic to 289,740, with a record 106,219 people hospitalized with the highly infectious respiratory disease.

Healthcare professionals and support staff, exhausted by the demands of the pandemic, have been watching patients die alone as millions of Americans refuse to follow medical advice to wear masks and avoid crowds in order to curb the virus' spread.

Potentially helping to rein in the outbreak, a vaccine could start reaching healthcare workers, first responders and nursing home residents as soon as Sunday, though more likely early next week, according to Trump administration officials.

US Army General Gustave Perna, the chief operating officer of the Trump administration's Operation Warp Speed vaccine development program, said all the vaccine doses remained in the hands of the pharmaceutical companies.

"But we've worked many rehearsals and planning cycles ... and that's why I'm confident that as soon as EUA (emergency use authorization) comes aboard, we'll start packing to the final destinations and distribution will begin within 24 hours," Perna said.

A panel of independent medical experts was set to decide yesterday whether to recommend a vaccine from Pfizer Inc and German partner BioNTech SE for emergency use authorization from the US Food and Drug Administration.

Saudi Arabia yesterday approved the use of the Pfizer-BioNTech vaccine, state media reported, becoming the second Gulf country after Bahrain to green-light the drug.

Britain's medicine regulator said anyone with a history of anaphylaxis to a medicine or food should not get the Pfizer-BioNTech vaccine, giving fuller guidance on an earlier allergy warning about the shot.

Meanwhile, the full results of a clinical trial for the Pfizer-BioNTech Covid-19 vaccine were published in the New England Journal of Medicine yesterday.

A second vaccine developed by Moderna is a week behind. Widespread inoculations, however, could take months.

Japan hit a record daily number of new infections yesterday as the country struggles to contain the third wave of the pandemic.

Health officials reported 2,820 new cases nationwide, breaking the record for the second day in row after the 2,810 infections registered on Wednesday.

The Bill and Melinda Gates Foundation said yesterday it had pledged $250 million in additional funding towards the global campaign to fight the pandemic.

Part of the funds will be channelled to the distribution of life-saving doses of Covid-19 vaccines to parts of Sub-Saharan Africa and South Asia.