POST Online Media Lite Edition



 

FDA authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 vaccines for use as booster dose

Christian Fernsby |
The U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.

Article continues below




The bivalent vaccines, which we will also refer to as “updated boosters,” contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.

The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.

The monovalent COVID-19 vaccines that are authorized or approved by the FDA and have been administered to millions of people in the United States since December 2020 contain a component from the original strain of SARS-CoV-2.

Individuals 18 years of age and older are eligible for a single booster dose of the Moderna COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

Individuals 12 years of age and older are eligible for a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

The Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent contain mRNA from the SARS-CoV-2 virus.

“The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants. We sought input from our outside experts on the inclusion of an omicron component in COVID-19 boosters to provide better protection against COVID-19,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

"We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently. The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations.

“The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization.”

Data Supporting the Moderna COVID-19 Vaccine, Bivalent Authorization

To evaluate the effectiveness of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for individuals 18 years of age and older, the FDA analyzed immune response data among approximately 600 individuals 18 years of age and older who had previously received a two-dose primary series and one booster dose of monovalent Moderna COVID-19 Vaccine.

These participants received a second booster dose of either the monovalent Moderna COVID-19 Vaccine or Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1) at least 3 months after the first booster dose.

After 28 days, the immune response against BA.1 of the participants who received the bivalent vaccine was better than the immune response of those who had received the monovalent Moderna COVID-19 Vaccine.

The safety of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for individuals 18 years of age and older is supported by safety data from a clinical study which evaluated a booster dose of Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1), safety data from clinical trials which evaluated primary and booster vaccination with the monovalent Moderna COVID-19 Vaccine, and postmarketing safety data with the monovalent Moderna COVID-19 Vaccine.

The safety data accrued with the bivalent vaccine (original and omicron BA.1) and with the monovalent Moderna COVID-19 Vaccine are relevant to the Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

The clinical study that evaluated the safety of a booster dose of the bivalent vaccine (original and omicron BA.1) included approximately 800 participants 18 years of age and older who had previously received a two dose primary series and one booster dose of the monovalent Moderna COVID-19 Vaccine, and then at least 3 months later, received a second booster dose with either the monovalent Moderna COVID-19 Vaccine or Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1).

Among the study participants who received the bivalent vaccine, the most commonly reported side effects included pain, redness and swelling at the injection site, fatigue, headache, muscle pain, joint pain, chills, swelling of the lymph nodes in the same arm of the injection, nausea/vomiting and fever.

Data Supporting the Pfizer-BioNTech COVID-19 Vaccine, Bivalent Authorization

To evaluate the effectiveness of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of age and older, the FDA analyzed immune response data among approximately 600 adults greater than 55 years of age who had previously received a 2-dose primary series and one booster dose with the monovalent Pfizer-BioNTech COVID-19 Vaccine.

These participants received a second booster dose of either the monovalent Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine (original and omicron BA.1) 4.7 to 13.1 months after the first booster dose.

After one month, the immune response against BA.1 of the participants who received the bivalent vaccine was better than the immune response of those who had received the monovalent Pfizer-BioNTech COVID-19 Vaccine.

The safety of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of age and older is based on safety data from a clinical study which evaluated a booster dose of Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine (original and omicron BA.1), safety data from clinical trials which evaluated primary and booster vaccination with the monovalent Pfizer-BioNTech COVID-19 Vaccine, and postmarketing safety data with the monovalent Pfizer-BioNTech COVID-19 Vaccine.

The safety data accrued with the bivalent vaccine (original and omicron BA.1) and with the monovalent Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID 19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

The clinical study that evaluated the safety of a booster dose of the bivalent vaccine (original and omicron BA.1) included approximately 600 participants greater than 55 years of age who had previously received a 2-dose primary series, one booster dose of the monovalent Pfizer-BioNTech COVID-19 Vaccine, and then 4.7 to 13.1 months later, received a second booster dose of either the monovalent Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine (original and omicron BA.1).

Among the study participants who received the bivalent vaccine, the most commonly reported side effects included pain, redness and swelling at the injection site, fatigue, headache, muscle pain, chills, joint pain, and fever.

The fact sheets for both bivalent COVID-19 vaccines for recipients and caregivers and for healthcare providers include information about the potential side effects, as well as the risks of myocarditis and pericarditis.

With this authorization, the FDA has also revised the EUA of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to remove the use of the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration for individuals 18 years of age and older and 12 years of age and older, respectively.

These monovalent vaccines continue to be authorized for use for administration of a primary series for individuals 6 months of age and older as described in the letters of authorization.

At this time, the Pfizer-BioNTech COVID-19 Vaccine remains authorized for administration of a single booster dose for individuals 5 through 11 years of age at least five months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine.


What to read next

Pfizer and BioNTech: Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against Omicron
UK: JCVI publishes advice on COVID-19 vaccines for autumn booster programme
U.S. approves new booster of COVID-19 vaccines, 'mix and match' dose

U.S.: Pacific storm will bring strong winds, heavy rain, and mountain snow

 
A strong storm that originated over the Pacific has tracked through the Great Basin and is currently transitioning across the Rockies to redevelop across the central High Plains later today into early Saturday morning.
 
 

Latest

U.S. drillers add oil and gas rigs to 586
Cold-Link Logistics will create 123 new jobs in Robeson County, North Carolina
ArcelorMittal plans Alabama mill to produce electrical steel, will create 1,300+ jobs
Manhattan Tunnel Project estimated to create 15,800 new jobs

NEWS

EPPO probes steel import tax fraud with searches in UK and Germany

Police investigate extensive data breach on Valio’s network
U.S.: Prolonged heavy rain and snowfall
Croatia: Investigation launched against 2 individuals and 1 company suspected of subsidy fraud
Latvia-Sweden subsea cable damaged in Baltic Sea
Storm brings rain and snow to southwest U.S.; snow on higher elevations
 

BUSINESS

U.S. oil rig count rises to 479

New York AG warns businesses against price gouging of eggs and poultry amid bird flu outbreak
Firms admit laundering Russian wood into EU
U.S. oil and gas rig count falls to 576
Kansas Governor announces $25M for Stafford County Transload Facility Project
Ukraine planning to resume port concessions in 2025
 

Trending Now

EU to support Envision AESC France's production of batteries for electric vehicles

Denmark supports hydrogen pipeline to Germany with $1.1bn of subsidies

EU invests over €1.2 billion in cross-border infrastructure

Maersk and Hapag-Lloyd launch Gemini Cooperation


POLITICS

South Africa raises national minimum wage to $1.55 per hour

Moldova announces tender for constructing wind, solar parks worth 200 mln euros
Denmark supports hydrogen pipeline to Germany with $1.1bn of subsidies
EU invests over €1.2 billion in cross-border infrastructure
More nuclear power plants will be approved across England and Wales
Colorado and United Kingdom sign agreement to foster trade and investment
 

Today We Recommend

Moldova announces tender for constructing wind, solar parks worth 200 mln euros


Highlights 

Cold-Link Logistics will create 123 new jobs in Robeson County, North Carolina

ArcelorMittal plans Alabama mill to produce electrical steel, will create 1,300+ jobs

Manhattan Tunnel Project estimated to create 15,800 new jobs


COMPANIES

Egypt unveils new Suez Canal navigation charts for expanded route

Maersk and Hapag-Lloyd launch Gemini Cooperation
EU to support Envision AESC France's production of batteries for electric vehicles
Ooredoo and ASN to build subsea cable for GCC countries and Iraq
Pratt & Whitney to expand manufacturing operations in North Carolina, create 325 jobs
GE Vernova to create 75 new jobs in Schenectady County, New York
 

CAREERS

Inizio appoints Colin Stanley as chief commercial officer

Bridgewest Group names operating partner and general manager, Europe
Keith Hale named group CEO to Unite Titian Software & Labguru (BioData)
Solithor appoints new CEO
McWin appoints Guillaume Charlin as managing partner
PrecisionLife: Bill Keating new chief commercial officer, diagnostics and healthcare
 

ECONOMY

U.S. becomes New Zealand's second largest export destination

Indonesia goes from $0.6 billion deficit to $5.9 billion surplus
Greece to repay $5.3 billion bailout debt early
Fraser Institute: Canada’s debt ranking falls from best in G7 to 7th worst
Kuwait reports $5.2 bln budget deficit in FY 2023-24
Eurozone reports modest Q1 GDP growth, stable annual inflation
 

EARNINGS

Ericsson Q2 sales down but North America up

Lockton revenue $3.55 billion
Motorcar Parts of America Q4 sales $189.5 million
Limoneira Q2 revenue $44.6 million
Lululemon athletica Q1 revenue increased 10% to $2.2 billion
PVH Q1 GAAP EBIT $205 million
 

OP-ED

Micromanaging is the worst enemy of efficiency and teamwork

Niger set to monetize massive gas reserves through Saharan natural gas pipeline
Putting the brakes on EV folly that choked the market
Oil discovery in Kavango Basin may mean huge benefits for Namibians
Cape Town and Dubai battle over Africa's energy future
Is America going to lose its superpower status?
 

AGRIFISH

U.S. resumes cattle and bison imports from Mexico under new protocol

Canada considers lowering tebuconazole residue limit on grapes, impacting U.S. imports
How expensive was agricultural land in Europe in 2023
Iran to import 50,000 tons of potatoes to stabilize prices amid rising food costs
JBS and partners donate 3 million tags to improve livestock traceability in Pará, Brazil
Hong Kong suspends of poultry meat and products from areas in U.S.
 

LEADERSHIP

Study: Missing a deadline has a bigger impact than you might think

Employers prefer younger job candidates for AI roles although experienced workers perform same or better
Study finds workers misjudge wage markets
Some organizations may need to expand their hierarchical structures earlier than others
Study finds there's right way and wrong way to deliver negative feedback in workplace
Allyship is critical and its needs appreciation
 

CRIME

Commission fines Pierre Cardin and its licensee Ahlers €5.7 million for restricting cross-border sales of clothing

BHP, Vale agree to pay $30B damages for Brazil dam disaster
Commission fines České dráhy and Österreichische Bundesbahnen €48.7 million over collusion to exclude common compe
SEC charges Keurig with making inaccurate statements regarding recyclability of K-Cup beverage pod
SEC charges John Deere with FCPA violations for subsidiary’s role in Thai bribery scheme
AG Bonta secures $3.9 million settlement with cryptocurrency company Robinhood
 

Magazine

TRAVEL

Radisson Hotel Group debuts in the heart of Tunisia’s capital city, Tunis

Morocco’s first Radisson branded hotel opens in Casablanca
Buna channels, an unreal and beautiful part of Bosnia and Herzegovina
JW Marriott unveils Mindful Haven with opening of JW Marriott Hotel Nairobi
Sotheby's Sports Week returns with fantastic artifacts
Red Roof properties open in Michigan
 

SEA, LAND, AIR

Citroën C3 Aircross, the most affordable compact SUV with 7 seats

2025 Chevrolet Equinox stands apart with fresh looks and capability
Hill Helicopters HX50, luxury in the sky
Opel Movano becomes fully equipped camper van
Porsche Panamera, new hybrid variants
Dodge Charger, 670 horsepower of electric
 

DESIGN

Cold night, hot fire pit, cool entertainment

Embellish your home with PVC panels
You'll have to hurry if you want one of 20 new Louis Vuitton watches
Luxury duvet looks good, fells good and keeps you healthy
Vacheron Constantin, watches for life and more
Schüller kitchens, where functionality marries design
 

GADGETS

MESA/Boogie Celebrates 40-year partnership with John Petrucci

reMarkable 2, monochrome tablet for your thoughts and your eyes
OnePlus Ace 3V, first with Snapdragon 7 Plus Gen 3
ASUS Zenfone 11 Ultra, flagship with a reason
Samsung Galaxy S24 is photography powerhouse
Casette tapes are making a big comeback, and so are portable players
 

HEALTH

Human cases of anthrax reported in western Mongolia

One more barrier to developing vaccine for HIV removed
Rwanda begins world's first clinical trial for treatment of Marburg virus disease
Rwanda restricts gatherings amid Marburg virus outbreak, to begin trials of vaccine
Teksas Attorney General reaches settlement in first-of-its-kind healthcare generative AI investigation
Potentially deadly fungal disease spreading in California
 

MEANTIME

India launches space docking experiment mission

World-first carbon-14 diamond battery made
Einstein Telescope step closer
Exoplanet-hunting telescope to begin search for another Earth in 2026
India to build first phase of its own space station by 2028
Roscosmos chief approves schedule of creating Russian orbital station through 2033