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Information relating to the one of the most promising coronavirus vaccines has been “unlawfully accessed” following a hack on the European regulatory body that’s in the final stages of approving it, the firms jointly developing the vaccine said on Wednesday.

The European Medicines Agency based in Amsterdam first disclosed the breach . The statement said only that the EMA had been subject to a cyberattack and that it had begun a joint investigation along with law enforcement. The agency didn’t say when the hack happened or whether the attackers sought vaccine information, to infect the network with ransomware, or to pursue some other purpose. An EMA spokesperson said in an email that “the Agency is fully functional and work continues.”

Around the same time on Wednesday, pharmaceutical company Pfizer and biotech company BioNTech, issued a joint release that said: “Today, we were informed by the European Medicines Agency (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, BNT162b2, which has been stored on an EMA server, had been unlawfully accessed.”

Enlarge / Margaret Keenan, 90, who was the first patient in the United Kingdom to receive the first of two doses of the Pfizer-BioNtech Covid-19 vaccine, reacts as she talks with Healthcare assistant Lorraine Hill, while preparing to leave University Hospital Coventry, in Coventry on December 9, 2020, a day after receiving the vaccine. (credit: Johnny Weeks | Getty Images)

People with a significant history of allergies should not receive the Pfizer/BioNTech coronavirus vaccine, the UK medical regulator has said, after two NHS staff experienced an adverse reaction.

June Raine, chief executive for the Medicines and Healthcare products Regulatory Agency (MHRA), told a UK parliamentary committee that the two individuals had the allergic reaction shortly after receiving the vaccine and that the regulator was investigating. Both people had a history of serious allergies and carried adrenalin pens.

“We know from the very extensive clinical trials that this wasn’t a feature but if we need to strengthen our advice . . . we get that advice to the field immediately,” Dr. Raine said.

Enlarge / US President Donald Trump in the Oval Office of the White House in Washington, DC on December 7, 2020. (credit: Getty | Saul Loeb )

The Trump administration will host a “Vaccine Summit” today at the White House. But notably absent from the vaccine-centered event will be any companies that actually make vaccines—including the companies leading the race for a COVID-19 vaccine, Moderna, Pfizer, and Pfizer's partner BioNTech.

The companies reportedly declined to attend or withdrew, which is seen as a snub to lame-duck President Trump. Senior officials for the Trump administration, meanwhile, said the administration decided to go “in a different direction.”

The Trump administration has pitched the unusual event as a way to educate the public about vaccine development, regulatory approval, and distribution processes and to congratulate the many players helping to develop COVID-19 vaccine candidates. The event includes a “fire-side chat” with top vaccine regulator Peter Marks from the Food and Drug Administration. There will also be talks with representatives from FedEx, UPS, McKesson, CVS and Walgreens, who will all help get any FDA-approved vaccines to people’s arms.

Enlarge / Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company d BioNTech. (credit: Getty | Photonews )

The very first doses of any approved COVID-19 vaccine should go to both front-line healthcare workers and residents of long-term care facilities, a committee of expert advisors for the Centers for Disease Control and Prevention recommended in an emergency meeting Tuesday evening .

The committee’s recommendation now moves to CDC director Robert Redfield for approval before it becomes official federal guidance. And, ultimately, states will make their own final decisions on how to distribute the first coveted shipments of vaccine vials.

Still, the committee—the Advisory Committee on Immunization Practices (ACIP)—has for decades set such vaccine policy recommendations and states are likely eager to have its guidance settled as they try to finalize their plans. States have only until this coming Friday, December 4, to place their first vaccine orders with the federal government. The orders will determine which facilities in each state will get vaccine shipments and how much vaccine each facility will receive out of their state's limited allotment.

Enlarge / An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. (credit: Getty | JUSTIN TALLIS )

Pharmaceutical giant Pfizer and German biotech firm BioNTech announced Wednesday that they have wrapped up the Phase III trial of their COVID-19 mRNA vaccine, finding it to be 95 percent effective at preventing disease and consistently effective across age, gender, race, and ethnicity demographics. The vaccine appeared effective at preventing cases of severe disease as well.

The companies added that they have also met a safety milestone—collecting a median of two months of safety monitoring data on trial participants—to file a request for an Emergency Use Authorization (EUA) with the US Food and Drug Administration. They plan to file the request “within days.”

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Dr. Albert Bourla, Pfizer Chairman and CEO, said in a statement. “We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world.”

Enlarge / Geneva: WHO Director-General Tedros Adhanom Ghebreyesus announced on March 11, 2020 that the new coronavirus outbreak can now be characterized as a pandemic. (credit: Getty | FABRICE COFFRINI )

There’s more good news on the COVID-19 vaccine front today: biotechnology company Moderna reported in a press release this morning that its mRNA vaccine appeared 94.5 percent effective at preventing COVID-19 in an interim analysis of a large, Phase III trial. The news comes exactly one week after similar results came out via press release for another mRNA vaccine developed by pharmaceutical giant Pfizer and German biotech firm BioNTech.

But, while health experts are “cautiously optimistic” for this and many other vaccines in the coming months, they warn that such a timeline will not be fast enough to spare lives and health care systems from the current spike in disease.

“Right now, we are extremely concerned by the surge in cases we’re seeing in some countries,” Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, said in a press conference Monday. “Particularly in Europe and the Americas, health workers and health systems are being pushed to the breaking point.”

Enlarge / Russia's President Vladimir Putin. (credit: Getty | Mikhail Klimentyev )

Russian President Vladimir Putin on Wednesday announced the second dubious approval of a COVID-19 vaccine that has not been evaluated in clinical trials.

The vaccine, dubbed EpiVacCorona, is said to be a synthetic peptide-based vaccine, which uses fragments of the pandemic virus, SARS-CoV-2, to spur protective immune responses in those vaccinated. It was developed by Vector State Virology and Biotechnology Center, a former Soviet bioweapons research lab.

Like the first Russian-approved vaccine, whether EpiVacCorona is actually safe and effective is completely unknown. In a televised news conference , Putin said that early trials involving 100 people were successful. But researchers have not published any safety or efficacy data from those trials. Russian health officials have said they are still reviewing the vaccine for “safety and quality” but declined to provide any additional information on the vaccine, data, or approval process.

Enlarge / Staff from South Sudan's Health Ministry pose with protective suits during a drill for Ebola preparedness conducted by the World Health Organization (WHO). (credit: Getty | Patrick Meinhardt )

The Food and Drug Administration on Tuesday issued the first-ever approval for a therapy against Ebola virus disease .

Though the Ebola vaccine, Ervebo, earned approval late last year and proved 97.5 percent effective in preliminary trials, the newly approved therapy may be useful in addressing an ongoing outbreak in Democratic Republic of Congo, which began in June. The FDA’s approval may also boost the outlook for similar therapies being developed for COVID-19, which may become available before a vaccine.

The newly approved Ebola treatment, called Inmazeb (aka REGN-EB3), is a combination of three monoclonal antibodies made by Regeneron Pharmaceuticals. The antibodies target the only protein on the outside of Ebola virus particles, the glycoprotein. Ebola uses its glycoprotein to attach to and enter human cells, sparking infection. The cocktail of antibodies glom on to the protein, keeping it from invading cells.

Enlarge / MOSCOW, RUSSIA - AUGUST 14, 2020: Alexander Gintsburg, director of the Gamaleya Scientific Research Institute of Epidemiology and Microbiology of the Russian Healthcare Ministry that produces a COVID-19 vaccine. (credit: Getty | Vyacheslav Prokofyev )

A top Russian researcher behind the Sputnik V coronavirus vaccine defended using the vaccine before testing was complete and said he plans to release clinical trial data early—so early, in fact, the data is unlikely to be interpretable.

Alexander Gintsburg, head of the Gamaleya Institute that developed Sputnik V, laid out his thoughts on the vaccine and the pandemic in an interview with Reuters published Tuesday.

“People are dying just like during a war,” Gintsburg said as he sat in his wood-paneled office in Moscow, holding a crystal model of a coronavirus. “But this fast-tracked pace is not synonymous—as some media have suggested—with corners being cut. No way.”