THE HAGUE/WASHINGTON – Documents related to the Pfizer coronavirus vaccine were illegally accessed during a cyberattack at the EU regulator, the company said Wednesday, as the United States registered more than 3,000 deaths in 24 hours and Germany and other northern hemisphere countries grappled with a winter surge in the pandemic.
The Amsterdam-based European Medicines Agency (EMA) reported the cyberattack as European countries eagerly await a vaccine, including Germany where Chancellor Angela Merkel is pushing for tougher action against a second wave of COVID-19 that is proving deadlier than the first there.
While the EMA did not give details on the attack, Pfizer and BioNTech said documents relating to their vaccine candidate had been accessed, but that ''no systems have been breached in connection with this incident.''
The EMA has promised to reach a decision on conditional approval for Pfizer/BioNTech's vaccine by December 29, with a ruling on Moderna's version to follow by January 12.
Those with severe allergy should avoid Pfizer shot
People with a significant history of allergies should not currently receive the COVID-19 vaccine from Pfizer Inc. and BioNTech SE, the UK’s National Health Service said, after two people experienced reactions from the shots.
The warning came a day after the UK became the first western nation to begin a COVID vaccination program, following approval of the shot last week by the Medicines and Healthcare Products Regulatory Agency. Thousands of people received vaccinations on Tuesday, according to the NHS.
“As is common with new vaccines, the MHRA have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination,” Stephen Powis, national medical director for the NHS in England, said in a statement.
June Raine, chief executive of the MHRA, said her team looked at two case reports of allergic reactions on Tuesday evening.
Both of the people, staff members of the NHS, are recovering well.
“We know from the very extensive clinical trials that this wasn’t a feature, that if we need to strengthen our advice now that we’ve had this experience in the vulnerable populations, we get that advice to the field immediately,” Raine told a panel of lawmakers.
Pfizer and BioNTech said they’re supporting the MHRA in its investigation.
The UK agency had already warned in its prescribing information that people who are allergic to any ingredients in the vaccine shouldn’t take it.
Patients with a history of severe adverse reactions to a vaccine or severe allergic reactions to any component of the treatment were excluded from participating in the large study run by the companies before approval.
“In the pivotal phase 3 clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent data monitoring committee,” the companies said in a statement.
Canada on Wednesday became the latest nation to approve the Pfizer- BioNTech vaccine, a day after Britain gave out the first approved vaccine jabs in the Western world.
The United States is expected to follow suit within days, after a Food and Drug Administration advisory panel meets on the issue Thursday.
Secretary of Defense Chris Miller and his top generals will be vaccinated for COVID-19 by next week after the expected approval of the Pfizer-BioNTech vaccine, Pentagon officials said Wednesday.
Miller, Deputy Defense Secretary David Norquist, Joint Chiefs Chairman General Mark Milley and Vice Chairman General John Hyten, and Joint Chiefs Senior Enlisted Advisor Ramon Colon-Lopez will be first in line for vaccinations to protect the US military's command structure, said Assistant Secretary of Defense for Health Affairs Thomas McCaffery.
The Pentagon will get an initial 44,000 doses of Pfizer's treatment, which could gain final approval from the Food and Drug Administration as early as late Thursday, he said.
The final step will be a review scheduled for Sunday by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.
''We are confident within 24 to 48 hours from that advisory committee decision, we will actually have shots in arms,'' said Lieutenant General Ronald Place, director of the Defense Health Agency.
But a top government scientist said the FDA would probably ask
people with a known history of severe allergies not to take it -- after two health care workers in Britain needed treatment for allergic reactions.
The cyberattack comes after Britain accused Kremlin-linked hackers in July of targeting labs researching coronavirus vaccines and after a US newspaper reported that cyber-criminals had tried to attack several pharmaceutical firms developing vaccines.
They included Johnson & Johnson, Novavax, AstraZeneca and South Korean laboratories.
Both Russia and China have already begun inoculation campaigns with domestically produced vaccines.
The Russian space agency said on Wednesday it planned to offer the Sputnik coronavirus vaccine to cosmonauts but insisted it would be on a voluntary basis.
Israel accepted its first shipment of the Pfizer vaccine on Wednesday, Prime Minister Benjamin Netanyahu promising to be the first to be injected -- although the vaccine has yet to pass regulatory hurdles there.
''What is important to me is that Israeli citizens get vaccinated,'' he said. ''I want to serve as an example to them.''
AU Commission chairman Moussa Faki Mahamat meanwhile said Wednesday that Africa must be among the first beneficiaries of the vaccines, adding that ''those who have the (financial) means must not monopolize the vaccines.''
South Africa, the country most affected by the coronavirus on the continent, has entered a second wave of the pandemic, the health minister declared Wednesday.
''This evening we wish to announce that as South Africa we are now experiencing a second wave,'' said Zweli Mkhize in a statement as the country registered nearly 7,000 new cases in the last 24-hour cycle.
The virus has now killed more than 1.5 million worldwide since it emerged in China late last year.
900,000-strong petition on COVID patents
The World Trade Organization said Wednesday it had received a 900,000-
signatory petition calling for patents to be lifted on COVID-19 vaccines and treatments.
The virtual petition, organized by the global citizen activism group Avaaz, was submitted ahead of Thursday's meeting of the Council for Trade Related Intellectual Property Rights (TRIPS).
WTO member states were set to continue talks on proposals to waive certain TRIPS obligations concerning the prevention, containment or treatment of COVID-19.
''Considerable differences remain between members over this proposal,'' the Geneva-based global trade body said.
The petition is addressed to all governments, WTO members and pharmaceutical companies.
"We call on you to urgently ensure access to lifesaving Covid-19 vaccines, treatments and equipment for everyone in the world,'' it reads.
''Patents should be lifted, technological knowledge shared freely and openly, and no profiteering allowed during this pandemic.
''Governments, scientists and pharmaceutical companies must cooperate and combine resources to ensure no one is left behind. The pandemic will not be over until it's over everywhere.''
Change 'for the better'
In Germany, where the daily death toll hit a new high of 590 on Wednesday, Merkel urged regions to take more drastic action to curb the virus spread, after state leaders agreed to ease what are already comparatively modest social restrictions for the Christmas holidays.
Merkel has been in no mood for celebration, repeatedly urging regional leaders who have responsibility for health policies to clamp down more strongly.
''If we have too many contacts before Christmas and it ends up being the last Christmas with the grandparents, then we'd really have failed,'' she said.
Two weeks ago, Germany's states agreed rules limiting social mixing to five people but agreed to double the limit to 10 for the holiday season —something Merkel argued against.
First doses in NY this weekend
New York is expected to receive its first doses of the coronavirus vaccine as early as this weekend, Governor Andrew Cuomo said Wednesday.
Cuomo said he expected the US Food and Drug Administration to grant emergency authorization for the Pfizer-BioNTech jab on Thursday, paving the way for delivery.
''We expect delivery of 170,000 doses as soon as this weekend,'' Cuomo said.
''First priority will be for nursing home residents and staff and high-risk hospital workers,'' he added.
The FDA announced on Tuesday that the Pfizer-BioNTech COVID-19 vaccine is safe and effective, raising expectations the regulator is poised to grant emergency approval.