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STORY BY ERIN BANCO, SARAH OWERMOHLE AND RACHEL ROUBEIN

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Pfizer Covid-19 vaccine Johnson & Johnson may not be ready to ship
Published on March 23, 2021 9:47 AM

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Liana Fonseca looks away as she receives the Pfizer Covid-19 vaccine in Miami on March 9, 2021. | Marta Lavandier/AP Photo
Biden administration officials are increasingly concerned Johnson & Johnson may not deliver the 20 million doses of coronavirus vaccine it promised would be available by the end of this month, according to three senior administration officials.

The full tranche of vaccine Johnson & Johnson committed in February to delivering may not be ready to ship until the second or third week of April, the officials said, potentially complicating preparations for states expecting millions of J&J shots.

Johnson & Johnson spokesperson Jake Sargent told POLITICO that the company "expect[s] to deliver 20 million single-shot vaccines by the end of March." But three individuals with knowledge of the situation, including two senior administration officials, say the current production process may be subject to logistical complications and regulatory delays. The White House did not comment.

Notably, J&J is shipping components from Europe to a U.S. "fill and finish" facility before sending the doses to the federal government, officials said. The company is also waiting for the Food and Drug Administration to authorize two key American partners, Emergent BioSolutions and Catalent, who'd send out "tens of millions" of usable shots, according to a person familiar with the process. That authorization is expected to materialize in the coming days, one individual with knowledge of the matter said, adding that it's believed the number of doses released would be in the "millions."


HISTORY

The Johnson & Johnson COVID-19 vaccine is a human adenovirus viral vector COVID-19 vaccine developed by Janssen Vaccines in Leiden in The Netherlands, and its Belgian parent company Janssen Pharmaceuticals, subsidiary of American company Johnson & Johnson (J&J).

Description The Johnson & Johnson COVID-19 vaccine consists of a replication-incompetent recombinant adenovirus type 26 vector expressing the severe acute respiratory syndrome coronavirus 2 spike protein in a stabilized conformation. The stabilized version of the spike protein – that includes two mutations in which the regular amino acids are replaced with prolines – was developed by researchers at the National Institute of Allergy and Infectious Diseases' Vaccine Research Center and the University of Texas at Austin. The vaccine also contains the following inactive ingredients: citric acid monohydrate, trisodium citrate dihydrate, ethanol , 2-hydroxypropyl-ß-cyclodextrin , polysorbate 80, sodium chloride, sodium hydroxide, and hydrochloric acid. Characteristics The Johnson & Johnson COVID-19 vaccine can remain viable for months in a standard refrigerator. Unlike the Pfizer–BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine, the Johnson & Johnson COVID-19 vaccine is administered as a single dose instead of two separate doses and it is not shipped frozen.

The storage and handling information in the Fact Sheet supersedes the storage and handling information on the carton and vial labels. The vaccine should not be stored frozen. Unpunctured vials may be stored between 9 to 25 °C for up to twelve hours.

Development During the COVID-19 pandemic, Johnson & Johnson committed over US$1 billion toward the development of a not-for-profit COVID-19 vaccine in partnership with the Biomedical Advanced Research and Development Authority Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services . Johnson & Johnson stated that 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'.

Inside of an Emergent BioSolutions facility where, in collaboration with Johnson & Johnson, vaccines are produced. Janssen Vaccines, in partnership with Beth Israel Deaconess Medical Center , is responsible for developing the vaccine candidate, based on the same technology used to make its Ebola vaccine.

Clinical trials Phase I-II In June 2020, Johnson & Johnson and the National Institute of Allergy and Infectious Diseases confirmed its intention to start a clinical trials of the Ad26.COV2.S vaccine in September 2020, with the possibility of Phase I/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 on 15 July 2020, and enrolled study participants in Belgium and the US. Interim results from the Phase I/IIa trial established the safety, reactogenicity, and immunogenicity of Ad26.COV2.S.

Phase III A Phase III clinical trial called ENSEMBLE started enrollment in September 2020, and completed enrollment on 17 December 2020. It was designed as a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single-dose vaccine versus placebo in adults aged 18 years and older. Study participants received a single intramuscular injection of Ad26.COV2.S at a dose level of 5×1010 virus particles on day one. The trial was paused on 12 October 2020, because a volunteer became ill, but the company said it found no evidence that the vaccine had caused the illness and announced on 23 October 2020, that it would resume the trial. On 29 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 COVID-19 at 28 days post-vaccination among all volunteers. The interim analysis was based on 468 cases of symptomatic COVID-19 among 43,783 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. No deaths related to COVID-19 were reported in the vaccine group, while five deaths in the placebo group were related to COVID-19. During the trial, no anaphylaxis was observed in participants.

A second Phase III clinical trial called ENSEMBLE 2 started enrollment on 12 November 2020. ENSEMBLE 2 differs from ENSEMBLE in that its study participants will receive two intramuscular injections of Ad26.COV2.S, one on day 1 and the next on day 57.

Manufacturing In April 2020, Johnson & Johnson entered a partnership with Catalent who will provide large-scale manufacturing of the Johnson & Johnson vaccine at Catalent's Bloomington, Indiana facility. In July 2020, the partnership was expanded to include Catalent's Anagni, Italy facility.

In July 2020, Johnson & Johnson pledged to deliver up to 300 million doses of its vaccine to the U.S., with 100 million upfront and an option for 200 million more. The deal, worth more than $1 billion, will be funded by the Biomedical Advanced Research and Development Authority and the U.S. Defense Department. The deal was confirmed on 5 August.

In September 2020, Grand River Aseptic Manufacturing agreed with Johnson & Johnson to support the manufacture of the vaccine, including technology transfer and fill and finish manufacture, at its Grand Rapids, Michigan facility.

In December 2020, Johnson & Johnson and Reig Jofre, a Spanish pharmaceutical company, entered into an agreement to manufacture the vaccine at Reig Jofre's Barcelona facility. If the European Medicines Agency grants approval to the vaccine by March 2021, a European Union regulator said that Johnson & Johnson could start supplying vaccines to EU states starting on April 2021.

In August 2020, Johnson & Johnson signed a contract with the U.S. federal government for US$1 billion, agreeing to deliver 100 million doses of the vaccine to the U.S. following the U.S. Food and Drug Administration grant of approval or emergency use authorization for the vaccine. Under its agreement with the U.S. government, Johnson & Johnson was targeted to produce 12 million doses by the end of February 2021, more than 60 million doses by the end of April 2021, and more than 100 million doses by the end of June 2021. However, in January 2021, Johnson & Johnson acknowledged manufacturing delays would likely prevent it from meeting its contract of 12 million doses delivered to the U.S. by the end of February. In late February 2021 congressional testimony by a company executive, however, Johnson & Johnson indicated that the company could deliver 20 million doses to the U.S. government by the end of March, and 100 million doses in the first half of 2021.

In February 2021, Sanofi and Johnson & Johnson struck a deal for Sanofi to provide support and infrastructure at Sanofi's Marcy-l'Étoile, France facility to manufacture approximately 12 million doses of the Johnson & Johnson vaccine per month once authorized.

In March 2021, Merck & Co and Johnson & Johnson struck a deal for Merck to manufacture the Johnson & Johnson vaccine at two facilities in the United States to help expand the manufacturing capacity of the vaccine using provisions of the Defense Production Act.

Europe 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 , a step to expedite EMA consideration of an expected conditional Marketing Authorisation Application. On 16 February 2021, Janssen applied to the EMA for conditional marketing authorization of the vaccine. The Committee for Medicinal Products for Human Use approved the COVID-19 Vaccine Janssen on 11 March. Shipments of the vaccine are scheduled to start in the second half of April, with a commitment to deliver at least 200 million doses to the EU in 2021.

United States On 4 February 2021, Janssen Biotech applied to the U.S. Food and Drug Administration for an EUA, and the FDA announced that its Vaccines and Related Biological Products Advisory Committee would meet on 26 February to consider the application. Johnson & Johnson announced that it planned to ship the vaccine immediately following authorization. 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 safety data are consistent with FDA EUA guidance for COVID-19 vaccines. At the 26 February meeting, VRBPAC voted unanimously 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 CDC Advisory Committee on Immunization Practices recommended the use of the vaccine for those aged 18 and older.

The vaccine is 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.[3] The vaccine requires only one dose and does not need to be stored frozen.

The vaccine started clinical trials in June 2020, with Phase III trials involving around 43,000 people. On 29 January 2021, Janssen announced that the vaccine was 66% effective in a one-dose regimen in preventing symptomatic COVID-19, with an 85% efficacy in preventing severe COVID-19.The most common side effects were pain at the injection site, headache, fatigue, muscle aches and nausea.Most of these side effects were mild to moderate in severity and lasted one or two days.