The stabilized version of the
spike proteinthat includes two mutations in which the regular
amino acids are replaced with
prolineswas developed by researchers at the
National Institute of Allergy and Infectious Diseases'
Vaccine Research Center and the
University of Texas at Austin. During the
COVID19 pandemic, Johnson & Johnson committed over toward development of a not-for-profit vaccine in partnership with the
Biomedical Advanced Research and Development Authority (BARDA) Office of the
Assistant Secretary for Preparedness and Response (ASPR) at the
U.S. Department of Health and Human Services (HHS). Johnson & Johnson said its vaccine project would be "at a not-for-profit level" as the company viewed it as "the fastest and the best way to find all the collaborations in the world to make this happen". In November, Johnson & Johnson announced that Janssen would commit about $604 million and BARDA would commit $454 million to fund the ENSEMBLE trial. facility where, in collaboration with Johnson & Johnson, vaccines are produced Johnson & Johnson subsidiary
Janssen Vaccines, in partnership with
Beth Israel Deaconess Medical Center (BIDMC), was responsible for developing the vaccine candidate, based on the same technology used to make its
Ebola vaccine.
Clinical trials Preclinical trials indicated that the vaccine effectively protected hamsters and
rhesus macaques from SARS‐CoV‐2.
Phase I–II In June 2020, Johnson & Johnson and the
National Institute of Allergy and Infectious Diseases (NIAID) confirmed that they planned to start clinical trials of the Ad26.COV2.S vaccine in September 2020, with the possibility of phaseI–IIa human clinical trials starting at an accelerated pace in the second half of July. A phase I–IIa clinical trial started with the recruitment of the first subject in July 2020 and enrolled study participants in Belgium and the US.
Phase III A phase III
clinical trial called ENSEMBLE started enrollment in September 2020 and completed enrollment in December 2020. The trial was paused in October 2020, because a volunteer became ill, In January 2021, Janssen announced safety and efficacy data from an interim analysis of ENSEMBLE trial data, which demonstrated the vaccine was 66% effective at preventing the combined endpoints of moderate and severe COVID19 at 28 days post-vaccination among all volunteers. The interim analysis was based on 468 cases of symptomatic COVID19 among 43,783 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. No deaths related to COVID19 were reported in the vaccine group, while five deaths in the placebo group were related to COVID19. Plasma from 8 participants showed greater neutralization activity against the
Delta variant than against
Beta. In February 2021, Janssen applied to the EMA for conditional marketing authorization of the vaccine. The European Commission approved the COVID19 Vaccine Janssen in March 2021.
United States In February 2021, Janssen Biotech applied to the US
Food and Drug Administration (FDA) for an emergency use authorization (EUA), and the FDA announced that its
Vaccines and Related Biological Products Advisory Committee (VRBPAC) would meet in February to consider the application. In February, ahead of the VRBPAC meeting, briefing documents from Janssen and the FDA were issued; the FDA document recommends granting the EUA, concluding that the results of the clinical trials and the safety data are consistent with FDA EUA guidance for COVID19 vaccines. At the 26 February meeting, VRBPAC voted unanimously (22–0) to recommend that an EUA for the vaccine be issued. The FDA granted the EUA for the vaccine the following day. In February, the
Advisory Committee on Immunization Practices (ACIP) of the
Centers for Disease Control and Prevention (CDC) recommended the use of the vaccine for those aged 18 and older. In April 2021, the CDC and the FDA issued a joint statement recommending that use of the Janssen vaccine be suspended, due to reports of six cases of
cerebral venous sinus thrombosis—a "rare and severe"
blood clot—in combination with low levels of blood platelets (
thrombocytopenia), in six women between the ages of 18 and 48 who had received the vaccine. The symptoms occurred 6–13 days after they had received the vaccination, and it was reported that one woman had died and a second woman had been hospitalized in critical condition. In April, the FDA and the CDC determined that the recommended pause regarding the use of the Janssen COVID19 Vaccine in the US should be lifted and use of the vaccine should resume. The EUA and the fact sheets were updated to reflect the risks of thrombosis-thrombocytopenia syndrome (TTS). In June 2023, the FDA revoked the emergency use authorization for the Janssen COVID-19 vaccine at the request of its manufacturer. In December 2020, Johnson & Johnson entered into an
agreement in principle with the
GAVI vaccine alliance to support the
COVAX Facility. In February 2021, Johnson & Johnson submitted its formal request and data package to the
World Health Organization for an Emergency Use Listing (EUL); an EUL is a requirement for participation in COVAX. Johnson & Johnson anticipated providing up to five hundred million doses through 2022 for COVAX. The World Health Organization issued an EUL for the Janssen COVID19 vaccine Ad26.COV2.S vaccine in March 2021. In February 2021, the vaccine received emergency authorization in
South Africa. The program resumed in April 2021. In February 2021, Bahrain authorized the vaccine for emergency use. In February 2021, the South Korean
Ministry of Food and Drug Safety began a review of Johnson & Johnson's application for approval of its vaccine. In late November 2020, Johnson & Johnson submitted a rolling review application to
Health Canada for approval of its vaccine. In March 2021, the vaccine received emergency authorization in Colombia. In March 2021, the vaccine was authorized under interim order in
Canada. In April 2021, the Australian government stated that it would not be purchasing the Janssen vaccine, as it "does not intend to purchase any further adenovirus vaccines at this time". The
Therapeutic Goods Administration granted provisional approval for use of the Janssen vaccine in Australia in June 2021. In May 2021, the vaccine received conditional marketing authorization in the United Kingdom. In June 2021,
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) issued conditional registration for emergency use of the vaccine. In June 2021, COVID19 Janssen Ad26.COV2.S was granted provisional approval in Australia. In July 2021, the vaccine received provisional approval for use for people aged 18 and above in
New Zealand. In August 2021, Health and Family Welfare Minister of India announced that Johnson and Johnson single-dose vaccine was approved for emergency use in India through a supply agreement with homegrown vaccine maker
Biological E. Limited. In September 2021,
National Agency of Drug and Food Control (BPOM) issued emergency use authorization in Indonesia. In November 2021, the vaccine's authorization under interim order in Canada was transitioned to approval for use under the country's Food and Drug Regulations.
Further development Homologous prime-boost vaccination In October 2021, the FDA and the CDC authorized the use of either homologous or heterologous vaccine booster doses.
Heterologous prime-boost vaccination In October 2021, the US
Food and Drug Administration (FDA) and the
Centers for Disease Control and Prevention (CDC) authorized the use of either homologous or heterologous vaccine booster doses. The authorization was expanded to include all adults in November 2021. == Society and culture ==