CORONAVIRUS

European Regulator To Decide Dec. 29 On 1st Virus Vaccine

Dec 1, 2020, 8:30 AM
FILE (Photo by Leonardo Fernandez Viloria/Getty Images)...
FILE (Photo by Leonardo Fernandez Viloria/Getty Images)
(Photo by Leonardo Fernandez Viloria/Getty Images)

BERLIN (AP) — The European Medicines Agency will convene a meeting on Dec. 29 to decide if there is enough data about the safety and efficacy of the COVID-19 vaccine developed by Pfizer and BioNTech for it to be approved, the regulator said Tuesday.

The agency also said Tuesday it could decide as early as Jan. 12 whether to approve a rival COVID-19 vaccine developed by Moderna Inc.

The German pharmaceutical company BioNTech and its U.S. partner Pfizer said earlier Tuesday that they had asked the regulator for speeded-up, conditional approval of their coronavirus vaccine, concluding the rolling review process they initiated with the agency on Oct. 6.

The move comes a day after rival Moderna said it was asking U.S. and European regulators to allow the use of its COVID-19 vaccine.

BioNTech said if the vaccine, currently named BNT162b2, is approved, its use in Europe could begin before the end of 2020.T he companies said last month that clinical trials with 44,000 participants showed the vaccine is 95% effective. The efficacy rate in particularly vulnerable older age groups was more than 94%, they said.

In a statement, the EU medicines regulator said it had already begun a “rolling review” of the Moderna vaccine based on laboratory data previously submitted by the company and would now assess data on how well that vaccine triggers an immune response and whether it is safe enough for broad use across Europe.

The agency said that “if the data are robust enough to conclude on quality, safety and effectiveness,” then it could approve the Moderna vaccine at a meeting scheduled for Jan. 12.

BioNTech and Pfizer have already submitted a request for emergency approval with the U.S. Food and Drug Administration and the U.K. regulator MHRA, as well as rolling submissions in other countries including in Australia, Canada and Japan.

“We have known since the beginning of this journey that patients are waiting, and we stand ready to ship COVID-19 vaccine doses as soon as potential authorizations will allow us,” Pfizer’s chief executive Albert Bourla said in a statement.

BioNTech said it stands ready to ship stockpiles of vaccines where they are needed when the Amsterdam-based agency or the FDA approve the vaccine.

“Depending on how the authorities decide we can start delivering within a few hours,” said BioNTech’s chief operating officer, Sierk Poetting.

The European Union’s top official said around 2 billion doses of potential COVID-19 vaccines have been secured for the bloc’s 27 nations, with the first deliveries likely to start before the end of the year.

EU Commission President Ursula von der Leyen said EU nations have started working on their vaccination plans and on the logistics for delivering tens of millions of doses across the bloc, a major challenge for the EU.

“If everything goes well, the first European citizens might already be vaccinated before the end of December,” Von der Leyen said. “And it will be a huge step forward toward our normal life. In other words, I just wanted to say there is a light at the end of the tunnel.”

The Commission, the EU’s executive arm, has secured deals allowing to purchase doses with Moderna, AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer and CureVac.

Von der Leyen however urged EU citizens to remain “disciplined till we have reached finally a vaccination that is appropriate to eradicate this virus.”

Germany’s science minister said Tuesday that the same safety standards are being applied in the approval process for coronavirus vaccines as for other drugs and that this would be key to gaining the widest possible public acceptance for COVID immunization.

Anja Karliczek cited the fact that Europan regulators plan to hold a public hearing on Dec. 11 about the approval request by BioNTech and Pfizer.

Speaking to reporters in Berlin, Karliczek stressed that the vaccine will be voluntary and that authorities will work hard to inform the public about possible side effects that a small percentage of recipients might experience after immunization, such as headaches, exhaustion and fever.

Marylyn Addo, a doctor at Hamburg’s UKE hospital who is involved in the trials for a rival vaccine, said the rapid development of a vaccine was the result of enormous efforts by scientists, early funding and experience from previous vaccines.

___

Cheng reported from London and Petrequin reported from Brussels.

KSL 5 TV Live

Top Stories

Coronavirus

(KSL-TV)...
Katija Stjepovic

Utah arts and cultural jobs are surging after COVID pandemic

The COVID-19 pandemic pulled the curtains on most of Utah's arts and cultural jobs, but after nearly three years, they are reemerging. 
2 days ago
...
Ashley Moser

Flu, COVID and RSV all trending down for the first time in months, says CDC

Major respiratory illnesses are all trending down for the first time since September, according to the CDC.
16 days ago
FILE PHOTO (Photo by Matthew Hatcher/Getty Images)...
Josh Ellis

Utah doctor, others charged with running COVID vaccine scheme, issuing fake records and giving fake shots

A Utah plastic surgeon, his medical corporation and three others have been charged after prosecutors say they issued fake COVID-19 vaccination record cards and injected minors with saline shots.
22 days ago
Dr. Angela Dunn, executive director of Salt Lake County Health Department, left, discusses schoolch...
Michael Houck

Salt Lake County ends its COVID-19 emergency status

After nearly three years, the Salt Lake County Health Department ended its COVID emergency status Tuesday. 
1 month ago
FILE: People line up in their cars as members of the Utah National Guard give COVID-19 swab tests a...
Eliza Pace

Gov. Cox, along with 24 other governors, call on President Biden to end Federal Public Health Emergency

Gov. Spencer Cox signed a letter with 24 other governors calling on President Joe Biden to end the federal public health emergency over the COVID-19 pandemic.
2 months ago
U.S. President Joe Biden welcomes guests to the East Room of the White House on December 14, 2022 i...
ZEKE MILLER, AP White House Correspondent

White House reveals winter COVID-19 plans, more free tests

The Biden administration is again making some free COVID-19 tests available to all U.S. households as it unveils its contingency plans for potential coronavirus surges this winter.
2 months ago

Sponsored Articles

vintage photo of lighting showroom featuring chandeliers, lamps, wall lights and mirrors...
Lighting Design

History of Lighting Design | Over 25 Years of Providing Utah With the Latest Trends and Styles

Read about the history of Lighting Design, a family-owned and operated business that paved the way for the lighting industry in Utah.
Fiber Optical cables connected to an optic ports and Network cables connected to ethernet ports...
Brian Huston, CE and Anthony Perkins, BICSI

Why Every Business Needs a Structured Cabling System

A structured cabling system benefits businesses by giving you faster processing speeds and making your network more efficient and reliable.
notebook with password notes highlighted...
PC Laptops

How to Create Strong Passwords You Can Actually Remember

Learn how you can create strong passwords that are actually easy to remember! In a short time you can create new ones in seconds.
house with for rent sign posted...
Chase Harrington, president and COO of Entrata

Top 5 Reasons You May Want to Consider Apartment Life Over Owning a Home

There are many benefits of renting that can be overshadowed by the allure of buying a home. Here are five reasons why renting might be right for you.
Festive kitchen in Christmas decorations. Christmas dining room....
Lighting Design

6 Holiday Decor Trends to Try in 2022

We've rounded out the top 6 holiday decor trends for 2022 so you can be ahead of the game before you start shopping. 
Happy diverse college or university students are having fun on their graduation day...
BYU MBA at the Marriott School of Business

How to Choose What MBA Program is Right for You: Take this Quiz Before You Apply!

Wondering what MBA program is right for you? Take this quiz before you apply to see if it will help you meet your goals.
European Regulator To Decide Dec. 29 On 1st Virus Vaccine