Johnson & Johnson (NYSE: JNJ) (the Company) today announced preliminary results from an independent study, including a subset of participants from the Janssen-sponsored COV2008 study, conducted by Dan Barouch, M.D., Ph.D., et al. of Beth Israel Deaconess Medical Center (BIDMC), which showed that a booster shot of the Johnson & Johnson COVID-19 vaccine (Ad26.COV2.S), administered at six months after a two-dose primary regimen of BNT162b2, increased both antibody and T-cell responses. These results demonstrate the potential benefits of heterologous boosting (mix-and-match). The article describing these results has been posted on medRxiv.

“There is early evidence to suggest that a mix-and-match boosting approach may provide individuals with different immune responses against COVID-19 than a homologous boosting approach,” said Dan Barouch, M.D., Ph.D., Director of the Center for Virology and Vaccine Research at BIDMC. “In this preliminary study, when a booster dose of Ad26.COV2.S was given to individuals six months after a primary regimen with the BNT162b2 vaccine, there was a comparable increase of antibody responses at week four following the boost and a greater increase of CD8+ T-cell responses with Ad26.COV2.S compared with BNT162b2.”

“These results provide valuable scientific insights for our vaccine when used as a mix-and-match booster and can help inform boosting strategies with the goal to curb the pandemic,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “These data add to the growing body of evidence demonstrating that a mix-and-match booster dose of the Johnson & Johnson COVID-19 vaccine successfully increases humoral responses and cellular responses against the original strain of SARS-CoV-2, as well as the Beta and Delta variants.”

hese Phase 2 data are reinforced by preliminary results from the UK COV-BOOST clinical study published in The Lancet, which demonstrated that following primary vaccination with two doses of either BNT162b2 (n=106) or ChAdOx1 nCov-19 (n=108), a booster dose of the Johnson & Johnson COVID-19 vaccine increased both antibody and T-cell responses.

Cellular (T-Cell) Responses

n this preliminary study, boosting with the Johnson & Johnson COVID-19 vaccine after a primary vaccine regimen of BNT162b2 appears to lead to a greater increase in CD8+ T-cell responses than boosting with BNT162b2. These T-cell response data suggest differences between immune responses following homologous boosting with BNT162b2, and mix-and-match boosting with the Johnson & Johnson COVID-19 vaccine following a primary regimen of BNT162b2.

The Johnson & Johnson COVID-19 vaccine leverages Janssen’s AdVac^® technology and cell-mediated immunity, including CD4+ and CD8+ responses. T-cells can target and destroy cells infected by the virus that causes COVID-19. Specifically, CD8+ T-cells can directly destroy infected cells and are aided by CD4+ T-cells.

Humoral (Antibody) Responses

Both the Johnson & Johnson COVID-19 vaccine and BNT162b2 as boosters led to similar neutralizing and binding antibody levels against the original SARS-CoV-2 strain, as well as the Delta and Beta variants, four weeks following the boost. However, after a mix-and-match booster dose of the Johnson & Johnson COVID-19 vaccine, antibodies continued to increase for at least four weeks whereas in individuals who received a homologous boost with the BNT162b2 vaccine, antibodies declined from week two to week four post-boost.

Neutralizing antibodies are capable of binding to the virus in a way that blocks infection and confines the virus to the upper respiratory tract. Binding antibodies can bind to the virus’ spike protein and inactivate the virus through non-neutralizing antiviral functionalities.

studija dizajna

For this study, a specimen biorepository at Beth Israel Deaconess Medical Center (BIDMC) obtained samples from individuals who received the BNT162b2 vaccine. Participants either continued follow-up in the biorepository and were boosted with 30 ug BNT162b2 (n=24) or were enrolled in the COV2008 study (NCT04999111) and were boosted with 5, 2.5, or 1×10¹⁰ vp of the Johnson & Johnson COVID-19 vaccine (n=41). The COV2008 study is a Johnson & Johnson sponsored, ongoing, blinded Phase 2 clinical trial (VAC31518COV2008) to evaluate its COVID-19 vaccine as a booster in adults 18 years of age and older.

The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the Johnson & Johnson COVID-19 vaccine as a booster for all eligible individuals aged 18 years and older who receive an authorized COVID-19 vaccine.

Johnson & Johnson continues to submit relevant data to other regulators, the World Health Organization (WHO) and National Immunization Technical Advisory Groups (NITAGs) worldwide to inform decision-making on local vaccine administration strategies, as needed.

In collaboration with academic groups in South Africa and around the world, the Company has been evaluating the effectiveness of its COVID-19 vaccine across variants, now including the new and rapidly spreading Omicron varijanta. In addition, the Company is pursuing an Omicron-specific variant vaccine and will progress it as needed.

For more information on the Company’s multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/covid-19.

Odobrena upotreba

The Johnson & Johnson COVID-19 vaccine, also referred to as the Janssen COVID-19 Vaccine, is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Primary vaccination regimen for the Janssen COVID-19 Vaccine is a single-dose (0.5 mL) administered to individuals 18 years of age and older.
A single Janssen COVID-19 Vaccine booster dose (0.5 mL) may be administered at least 2 months after the primary vaccination to individuals 18 years of age and older.
A single booster dose of the Janssen COVID-19 Vaccine (0.5 mL) may be administered to individuals 18 years of age and older as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination.

VAŽNE SIGURNOSNE INFORMACIJE

ell the vaccination provider about all of your medical conditions, including if you:

have any allergies
imaju groznicu
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects your immune system
are pregnant or plan to become pregnant
doje
have received another COVID-19 vaccine
have ever fainted in association with an injection

Ne biste trebali primiti Janssen vakcinu protiv COVID-19 ako:

had a severe allergic reaction after a previous dose of this vaccine
had a severe allergic reaction to any ingredient of this vaccine.

Janssen vakcina protiv COVID-19 će vam biti data kao injekcija u mišić.

Primary Vaccination: The Janssen COVID-19 Vaccine is administered as a single dose.

Booster doza:

A single booster dose of the Janssen COVID-19 Vaccine may be administered at least two months after primary vaccination with the Janssen COVID-19 Vaccine.
A single booster dose of the Janssen COVID-19 Vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. Please check with your health care provider regarding timing of the booster dose.

Nuspojave koje su prijavljene kod Janssen vakcine protiv COVID-19 uključuju:

Injection site reactions: pain, redness of the skin, and swelling.
General side effects: headache, feeling very tired, muscle aches, nausea, fever.
Otečeni limfni čvorovi.
Krvava odjeća.
Unusual feeling in the skin (such as tingling or a crawling feeling) (paresthesia), decreased feeling or sensitivity, especially in the skin (hypoesthesia).
Persistent ringing in the ears (tinnitus).
Diarrhea, vomiting.

Postoji mala šansa da Janssen vakcina protiv COVID-19 može izazvati tešku alergijsku reakciju. Teška alergijska reakcija obično se javlja u roku od nekoliko minuta do jednog sata nakon uzimanja doze Janssen vakcine protiv COVID-19. Iz tog razloga, vaš centar za vakcinaciju može od vas tražiti da ostanete na mjestu gdje ste primili vakcinu radi praćenja nakon vakcinacije. Znakovi teške alergijske reakcije mogu uključivati:

otežano disanje
Swelling of your face and throat
Ubrzan rad srca
A bad rash all over your body
Dizziness and weakness

Krvni ugrušci sa niskim nivoom trombocita

Krvni ugrušci koji zahvaćaju krvne žile u mozgu, plućima, abdomenu i nogama, zajedno s niskim razinama trombocita (krvnih stanica koje pomažu vašem tijelu da zaustavi krvarenje), pojavili su se kod nekih ljudi koji su primili Janssen COVID-19 vakcinu. Kod ljudi koji su razvili ove krvne ugruške i nizak nivo trombocita, simptomi su počeli otprilike jednu do dvije sedmice nakon vakcinacije. Izvještavanje o ovim krvnim ugrušcima i niskim razinama trombocita bilo je najviše kod žena u dobi od 18 do 49 godina. Šansa da se to dogodi je mala. Trebali biste odmah potražiti liječničku pomoć ako imate bilo koji od sljedećih simptoma nakon primitka Janssen vakcine protiv COVID-19:

kratak dah,
Bol u prsima,
Leg swelling,
Persistent abdominal pain,
Severe or persistent headaches or blurred vision,
Easy bruising or tiny blood spots under the skin beyond the site of the injection.

Ovo možda nisu sve moguće nuspojave Janssen COVID-19 vakcine. Mogu se javiti ozbiljni i neočekivani efekti. Vakcina Janssen COVID-19 se još uvijek proučava u kliničkim ispitivanjima.

Guillain Barréov sindrom

Guillain Barréov sindrom (neurološki poremećaj u kojem imunološki sistem tijela oštećuje nervne ćelije, uzrokujući slabost mišića, a ponekad i paralizu) pojavio se kod nekih ljudi koji su primili Janssen COVID-19 vakcinu. Kod većine ovih ljudi simptomi su počeli u roku od 42 dana nakon prijema Janssen vakcine protiv COVID-19. Šansa da se to dogodi je vrlo mala. Trebali biste odmah potražiti liječničku pomoć ako razvijete bilo koji od sljedećih simptoma nakon primanja Janssen vakcine protiv COVID-19:

Weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body.
Poteškoće u hodanju.
Difficulty with facial movements, including speaking, chewing, or swallowing.
Double vision or inability to move eyes.
Difficulty with bladder control or bowel function.

ŠTA UZIMATI IZ OVOG ČLANKA:

S was given to individuals six months after a primary regimen with the BNT162b2 vaccine, there was a comparable increase of antibody responses at week four following the boost and a greater increase of CD8+ T-cell responses with Ad26.
hese Phase 2 data are reinforced by preliminary results from the UK COV-BOOST clinical study published in The Lancet, which demonstrated that following primary vaccination with two doses of either BNT162b2 (n=106) or ChAdOx1 nCov-19 (n=108), a booster dose of the Johnson &.
Participants either continued follow-up in the biorepository and were boosted with 30 ug BNT162b2 (n=24) or were enrolled in the COV2008 study (NCT04999111) and were boosted with 5, 2.