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Johnson & Johnson has a goal to manufacture one billion doses of vaccine this year.
Courtesy Johnson & Johnson
Johnson & Johnson
says it can produce enough doses of its Covid-19 vaccine this year to inoculate nearly a billion people against the virus.
That would be a big shot in the arm for the effort to end the pandemic – as long as the vaccine works. Its effectiveness should be clear in a few days.
Speaking at an industry conference on Monday, Johnson & Johnson CEO (ticker: JNJ) Alex Gorsky said the company is in the “final stages” of analyzing data from its Phase 3 trial of 45,000 patients from the single dose of your vaccine. Bloomberg also said on Monday that the study would be ready to be submitted to the U.S. Food and Drug Administration for emergency authorization on January 21, citing a report in a South African newspaper.
“We hope to have this information very soon,” said Gorsky, referring to the results of the study, in a panel on
JP Morganin
annual health conference.
The data from this Phase 3 trial, called Ensemble, is perhaps the most anticipated data from pharmaceutical studies earlier this year. If positive, the results could accelerate Covid-19’s overall vaccination effort, increasing the number of doses available and introducing a vaccine option that will be much easier for public health officials to handle.
In other words, it can change the course of the pandemic.
Unlike vaccines for
Pfizer
(PFE) and
Modern
(MRNA), which requires a two-dose regimen, the Johnson & Johnson vaccine is being tested in a single dose formulation. The vaccine is also not subject to the same heavy storage requirements as the two authorized vaccines.
“JNJ data may be the most influential event of the month due to its potential impact on the market and the [Moderna] and [Pfizer] as pioneering players in the market, ”Jared Holz, analyst at Jefferies’ health trading desk, wrote in an email to investors on Monday. “JNJ, as a single injection that has a less complicated supply chain around it, can be very important.”
The Moderna and Pfizer vaccines, however, set a high standard in their Phase 3 trials, with each reporting efficacy rates above 90%. Although the results are difficult to compare across trials, a significantly weaker demonstration of the Johnson & Johnson vaccine could complicate its launch.
“The market consensus is approximately 85% + effectiveness” for the Johnson & Johnson vaccine, wrote Jefferies analyst Michael Yee in a January 8 note. Less than “85% would be materially weaker,” he said.
If the vaccine works well enough to receive FDA authorization, but considerably worse than the previously authorized Moderna and Pfizer vaccines, this can create dilemmas for employees and healthcare providers. Although the Johnson & Johnson vaccine is easier and cheaper to distribute, patients may be hesitant to obtain a vaccine considered less protective.
In addition to the Ensemble trial, Johnson & Johnson is conducting another Phase 3 trial of the vaccine, called Ensemble 2, which is testing a two-dose vaccine regimen.
Gorsky said in his presentation on Monday that the company has a goal of making “close to 1 billion” doses by the end of this year. If the data from the Ensemble trial is positive, that would be enough to inoculate about a billion people. Speaking in a separate presentation on Monday, the CEO of
BioNTech
(BNTX), which worked with Pfizer on its Covid-19 vaccine, said the companies hope to manufacture 2 billion doses of their vaccine this year, enough to inoculate 1 billion people.
Although not a major vaccine manufacturer, Johnson & Johnson was the first major pharmaceutical company to announce a Covid-19 vaccine program in January 2020. Its vaccine, which uses an altered version of a cold virus called Ad26 to transport DNA for a piece of the SARS-CoV-2 virus in the patient’s cells, uses a platform the company had previously used to make an Ebola vaccine.
Johnson & Johnson’s shares fell 0.4% on Monday, and rose almost 0.3% in Tuesday’s pre-market, compared to
S&P 500
future gain of 0.2%. The stock rose 8.8% in the last 12 months and is trading at 17.8 times the expected profit for the next 12 months, above the 5-year average of 16.4 times the profit. Of the 18 analysts accompanied by FactSet who cover the shares, 12 classify it as Overweight or Buy, five classify it as Hold and one classifies it as Sell.
Write to Josh Nathan-Kazis at [email protected]