Keypoints
- J&J presented data to the 19-member committee indicating that its vaccine loses efficacy over time, and that a booster shot is safe and can help restore both efficacy and levels of protective antibodies.
- Johnson & Johnson’s Covid-19 vaccine booster gained a key recommendation from advisers to U.S. regulators that brings the additional shot a step closer to clearance.
- The Vaccines and Related Biological Products Advisory Committee voted 19 to 0 that anyone who received the J&J vaccine should be offered a second dose.
- A COVID booster shot is an additional dose of a vaccine given after the protection provided by the original shot(s) has begun to decrease over time.
- Booster shot at six months provided a 12-fold increase in antibodies
- The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) on February 27, 2021.
- The USFDA approved the J&J vaccine based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective.
- WHO added the J&J vaccine to the list of safe and effective emergency tools against COVID-19 on March 12, 2021.
- Johnson and Johnson’s single-dose Covid-19 vaccine has been given approval for emergency use in India on August 7, 2021.
- The booster shot would be granted an emergency use authorization, used to speed the approval of products during public health emergencies, and not a traditional approval.
USFDA Panel endorses Johnson and Johnson COVID-19 Vaccine booster.
Johnson & Johnson’s Covid vaccine booster gained a key recommendation from advisers to U.S. regulators that brings the additional shot a step closer to clearance.
The Food and Drug Administration’s vaccine advisory group voted unanimously Friday in favor of recommending the booster for people 18 and older who received their initial immunization at least two months earlier. The experts also indicated support for mixing and matching booster shots from different manufacturers, but didn’t vote on a recommendation.
J&J presented data to the 19-member committee indicating that its vaccine loses efficacy over time, and that a booster shot is safe and can help restore both efficacy and levels of protective antibodies. The panel was originally asked to consider whether a six-month interval would be more effective, but decided not to consider that question.
Seen as a convenient, effective alternative to two-shot messenger RNA vaccines, J&J’s single-shot immunization has seen far less use in the U.S. The vaccine has demonstrated less efficacy than Moderna and Pfizer products, and the recommendation on J&J’s booster is the broadest to date, as the panel was concerned about recipients getting sufficient protection from one dose.
The recommendation is another step toward ensuring that recipients of the company’s vaccine have the opportunity to increase their protection, said Mathai Mammen, global head of research and development for J&J’s Janssen unit.
“We look forward to sharing these data with regulatory bodies and advisory groups around the world to address the continued threat of Covid-19,” he said.
What is the Covid-19 Vaccine booster?
A COVID booster shot is an additional dose of a vaccine given after the protection provided by the original shot(s) has begun to decrease over time. Typically, you would get a booster after the immunity from the initial dose(s) naturally starts to wane. The booster is designed to help people maintain their level of immunity for longer.
Why do we need to take a booster shot?
J&J presented results from a large study that found giving a second dose just two months after the first bumped protection against symptomatic COVID-19 to 94% from 70% in U.S. recipients. Giving that booster six months later instead prompted an even bigger jump in virus-fighting antibodies.
When a booster of the Johnson & Johnson COVID-19 vaccine was given six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster. All rises were irrespective of age.
What is J&J covid-19 vaccine?
The Janssen COVID-19 vaccine or Johnson & Johnson COVID-19 vaccine is a COVID-19 vaccine that was developed by Janssen Vaccines in Leiden, the Netherlands, and its Belgian parent company Janssen Pharmaceuticals, subsidiary of American company Johnson & Johnson.
It is a viral vector vaccine based on a human adenovirus that has been modified to contain the gene for making the spike protein of the SARS-CoV-2 virus that causes COVID-19. The body’s immune system responds to this spike protein to produce antibodies. The vaccine requires only one dose and does not need to be stored frozen.
Pharmacology
The vaccine consists of a replication-incompetent recombinant adenovirus type 26 (Ad26) vector expressing the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein in a stabilized conformation.[5][41] It is similar to the approach used by the Oxford–AstraZeneca COVID-19 vaccine and the Russian Sputnik V COVID-19 vaccine.
Chemistry
The vaccine contains the following excipients (inactive ingredients): citric acid monohydrate, trisodium citrate dihydrate, ethanol (alcohol), 2-hydroxypropyl-β-cyclodextrin (HBCD) (hydroxypropyl betadex), polysorbate 80, sodium chloride, sodium hydroxide, and hydrochloric acid.
FDA approval to J&J Covid-19 vaccine.
Johnson & Johnson (NYSE: JNJ) (the Company) On February 27, 2021 announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.
This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.
Terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.
“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”
“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants. A vaccine that protects against COVID-19, especially against the most direct outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “We look forward to our continued efforts around the world as we collectively aim to change the trajectory of this global pandemic.”
Johnson & Johnson is committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The Company has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S. The Company plans to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021. The U.S. government will manage allocation and distribution of the vaccine in the U.S. This will be prioritized according to the populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP) guidelines.
Johnson & Johnson also recently announced its submission of a European Conditional Marketing Authorisation Application to the European Medicines Agency as well as its filing for an Emergency Use Listing (EUL) with the World Health Organization for its COVID-19 vaccine candidate. In addition, rolling submissions for the single-dose COVID-19 vaccine candidate have been initiated in several countries worldwide.
The EUA follows a unanimous vote by the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021.
“We are thankful for the efforts of all those who have volunteered to participate in our clinical trials, our scientists, collaborators, clinical trial sites and investigators. Through the combined commitment of everyone involved, we have been able to discover, develop and manufacture a single-shot COVID-19 vaccine to protect people around the world,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson.
Phase 3 ENSEMBLE Study Design Of J&J Covid-19 vaccine
The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial in individuals 18 years of age and older. The study was designed to evaluate the safety and efficacy of the Company’s vaccine candidate in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints. The study enrolled a total of 43,783 participants.
The trial, conducted in eight countries across three continents, includes a diverse and broad population including 34 percent of participants over age 60.
The study enrolled 44 percent of participants in the United States. Seventy-four percent of participants in the U.S. are White/Caucasian; 15 percent are Hispanic and/or Latinx; 13 percent are Black/African American; 6 percent are Asian and 1 percent are Native American.
Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19.
Research and development activities for the Company’s COVID-19 vaccine, including the ENSEMBLE clinical trial and the delivery of doses for the U.S., has been funded in part with federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201700018C, and in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services (HHS).
Johnson & Johnson has worked with BARDA since 2015 on innovative solutions for influenza, chemical, biological, radiation and nuclear threats and emerging infectious diseases such as Ebola.
WHO added J&J vaccine to list of safe and effective emergency tools against COVID-19
The World Health Organization (WHO) on March 12, 2021 listed the COVID-19 vaccine Ad26.COV2.S, developed by Janssen (Johnson & Johnson), for emergency use in all countries and for COVAX roll-out. The decision comes on the back of the European Medicines Agency (EMA) authorization, which was announced one day before.
“Every new, safe and effective tool against COVID-19 is another step closer to controlling the pandemic,” said WHO Director-General, Dr Tedros Adhanom Ghebreyesus. “But the hope offered by these tools will not materialize unless they are made available to all people in all countries. I urge governments and companies to live up to their commitments and to use all solutions at their disposal to ramp up production so that these tools become truly global public goods, available and affordable to all, and a shared solution to the global crisis.”
The vaccine from Janssen is the first to be listed by WHO as a single dose regimen, which should facilitate vaccination logistics in all countries. The ample data from large clinical trials shared by the company also shows that the vaccine is effective in older populations.
Johnson and Johnson’s Covid-19 vaccine also got approval for emergency use in India.
Johnson and Johnson’s single-dose Covid-19 vaccine has been given approval for emergency use in India, Union health minister Mansukh Mandaviya said on Aug 7, 2021. This will further boost the country’s collective fight again novel coronavirus.
. “On 5th August 2021 Johnson & Johnson Pvt. Ltd applied for Emergency Use Authorization (EUA) of its single-dose COVID-19 vaccine to the Government of India. This is an important milestone that paves the way to bringing our single-dose COVID-19 vaccine to the people of India, and the rest of the world, through a collaboration with Biological E. Limited,” the company’s India spokesperson said.
The healthcare major got India’s approval of its vaccine a day after it applied for Emergency Use Authorisation (EUA). The company on Friday said that Biological E will be an important part of Johnson and Johnson’s global supply chain network, helping to supply its COVID-19 vaccine Janssen through extensive collaborations and partnerships with governments, health authorities and organisations such as Gavi and the COVAX Facility.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Other recently approved booster shots.
FDA’s Vaccine and Related Biological Products Advisory Committee voted to back Moderna Inc.’s booster Thursday, and additional shots from the partnership of Pfizer Inc. and BioNTech SE were authorized in September with the panel’s support. While President Joe Biden had foreseen offering boosters to all vaccinated Americans eight months after their first dose, the panel had until now recommended them for people at least 65 years old and younger adults who risk severe illness or viral exposure at work.
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