COVID-19 VACCINE LETHAL INJECTIONS

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Johnson & Johnson
COVID-19 Vaccine

(Johnson & Johnson, USA)

The Official Story

JANSSEN COVID-19 VACCINE
(Johnson & Johnson, USA)

The Janssen COVID 19 vaccine, sold under the brand name Jcovden, is a COVID 19 vaccine that was developed by Janssen Vaccines in Leiden, Netherlands, and its Belgian parent company Janssen Pharmaceuticals, a 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.

Clinical trials for the vaccine were started in June 2020, with phase III involving around 43,000 people. On 29 January 2021, Janssen announced that 28 days after a completed vaccination, the vaccine was 66% effective in a one-dose regimen in preventing symptomatic COVID 19, with an 85% efficacy in preventing severe COVID 19 and 100% efficacy in preventing hospitalization or death caused by the disease.

The vaccine has been granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) and a conditional marketing authorization by the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency.

Because cases of thrombosis with thrombocytopenia syndrome and Guillain-Barré syndrome have been reported after receipt of the Janssen COVID 19 vaccine, the US Centers for Disease Control and Prevention (CDC) recommends “preferential use of mRNA COVID 19 vaccines over the Janssen COVID 19 vaccine, including both primary and booster doses administered to prevent COVID 19, for all persons aged 18 years of age and older. The Janssen COVID 19 vaccine may be considered in some situations, including for persons with a contraindication to receipt of mRNA COVID 19 vaccines.” In February 2022, Johnson & Johnson announced it has temporarily suspended production of the vaccine though they also noted that it will likely resume at some point in the future and that it will honor all pre-existing contracts that oblige Janssen to supply its vaccine by using the millions of already existing vaccine doses in its inventory where requested.

Pharmacology

The vaccine consists of a replication-incompetent recombinant adenovirus type 26 (Ad26) viral vector expressing the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein in a stabilized conformation. The PER.C6 cell line derived from human embryonic retinal cells is used in the production (replication) of the Ad26 adenovirus vector. It is similar to the approach used by the Oxford–AstraZeneca COVID-19 vaccine and the Russian Sputnik V COVID-19 vaccine which use human embryonic kidney (HEK) 293 cells for adenovirus vector replication.

The Ad26 viral vector lacks the E1 gene required for replication. Therefore, it cannot replicate in the human organism.

Authorizations

European Union

Beginning on 1 December 2020, clinical trial of the vaccine candidate has been undergoing a “rolling review” process by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA), a step to expedite EMA consideration of an expected conditional marketing authorization. On 16 February 2021, Janssen applied to the EMA for conditional marketing authorization of the vaccine. The European Commission approved the COVID 19 Vaccine Janssen on 11 March 2021. In Finland, the Janssen vaccine is only offered for those aged 65 and over.

United States

On 4 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 on 26 February to consider the application. On 24 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 COVID 19 vaccines. At the 26 February meeting, VRBPAC voted unanimously (22–0) to recommend that a EUA for the vaccine be issued. The FDA granted the EUA for the vaccine the following day. On 28 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.

On 13 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.

On 23 April, the FDA and the CDC determined that the recommended pause regarding the use of the Janssen COVID 19 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).

Elsewhere

On 11 February 2021, Saint Vincent and the Grenadines issued an emergency authorization for the Janssen COVID 19 vaccine, as well as the Moderna COVID 19 vaccine, the Pfizer–BioNTech vaccine, the Gam-COVID-Vac vaccine (Sputnik V), and the Oxford–AstraZeneca vaccine.

In December 2020, Johnson & Johnson entered into an agreement in principle with the GAVI vaccine alliance to support the COVAX Facility. On 19 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 anticipates providing up to five hundred million doses through 2022 for COVAX. The World Health Organization issued an EUL for the Janssen COVID 19 vaccine Ad26.COV2.S vaccine on 12 March 2021.

On 18 February 2021, the vaccine received emergency authorization in South Africa. On 13 April 2021, South Africa suspended its rollout of the vaccine. The program resumed on 28 April 2021.

On 25 February 2021, Bahrain authorized the vaccine for emergency use.

On 26 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.

On 26 March 2021, the vaccine received emergency authorization in Colombia.

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 on 25 June 2021.

On 19 April 2021, the vaccine received emergency use authorization in the Philippines.

On 28 May 2021, the vaccine received conditional marketing authorization in the United Kingdom.

On 10 June 2021, the vaccine received emergency use authorization in Chile. The vaccine will be provided via COVAX.

On 15 June 2021, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) issued conditional registration for emergency use of the vaccine.

On 25 June 2021, COVID 19 Janssen Ad26.COV2.S was granted provisional approval in Australia.

On 7 July 2021, the vaccine received provisional approval for use for people aged 18 and above in New Zealand.

On 7 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.

On 7 September 2021, National Agency of Drug and Food Control (BPOM) issued emergency use authorization in Indonesia.

On 23 November 2021, the vaccine was approved for use in Canada.

Source: Wikipedia

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Janssen COVID-19 Vaccine

The Janssen COVID-19 vaccine is a viral vector vaccine produced by Janssen Pharmaceutica (a subsidiary of Johnson & Johnson) and Beth Israel Deaconess Medical Center. It is also known as Johnson & Johnson COVID-19 Vaccine and as COVID-19 Vaccine Janssen. Three countries, Denmark, Finland, and Norway, discontinued the use of the Janssen vaccine in favor of other available vaccines due to a possible link between the vaccine and a rare blood clot disorder. The use of the Janssen adenovirus vector vaccine began in Finland in October 2021. It is only offered for those aged 65 and over because of a very rare risk of thrombosis in younger age groups.

Janssen Worldwide Authorizations

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