Coronavirus update: Johnson & Johnson vaccine enters phase 3 as Fauci heads to Senate

(Yahoo Finance) – Johnson & Johnson (JNJ) announced on Wednesday that its coronavirus vaccine candidate had entered the late stage clinical phase, becoming the fourth company to do so in the global search for an effective COVID-19 inoculation.

The drug giant, whose candidate is a late entrant into the Phase 3 stage of development, previously announced its single-dose candidate. However, JNJ’s treatment differs in key ways from those being developed by the likes of Moderna (MRNA), Pfizer (PFE) and Novavax (NVAX), and will have more than 60,000 participants globally. The news helped to boost markets in pre-market action.

While two of the U.S. frontrunners employ mRNA technology, J&J’s approach is more similar to AstraZeneca (AZN) which has halted trials in the U.S. after an unexplained illness in a participant in the U.K. trial. While the U.K. has resumed its Phase 3 trial, the U.S. continues to investigate.

J&J’s candidate does not need the same freezing temperatures for storage that are making the two leading candidates a challenge to distribute. The adenovirus vector technology is stable at room temperature, which bodes well for global distribution and production.

J&J’s trials, done in collaboration with the National Institute of Allergy and Infectious Diseases, adds to a growing portfolio of COVID-19 inoculation candidates in the U.S. that are being developed at a record-breaking pace.

“Four COVID-19 vaccine candidates are in Phase 3 clinical testing in the United States just over eight months after SARS-CoV-2 was identified,” said NIAID director Anthony Fauci, in a statement.

“This is an unprecedented feat for the scientific community made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia,” he added.

Meanwhile, the U.S. Centers for Disease Control & Prevention (CDC) is gearing up for distribution of whichever candidate is proven safe first, having earlier notified states to prepare for such an event.

On Wednesday, the CDC announced it will award $200 million to 64 jurisdictions participating in the existing Immunizations and Vaccines for Children cooperative agreement. That program, which first began in 2008, has disbursed more than $4.1 billion in efforts to ensure immunization for children in the U.S.

“With these $200 million in new funds, jurisdictions can develop and update plans for the eventual distribution and administration of the safe and effective vaccines that will help bring this pandemic to an end,” U.S. Health and Human Services (HHS) Sec. Alex Azar said in a statement.

There are over 31 million cases worldwide. (Graphic: David Foster/Yahoo Finance)
There are over 31 million cases worldwide. (Graphic: David Foster/Yahoo Finance)

Health officials face Congress

Four top health officials set to face a Congressional committee to answer questions about the federal response to the COVID-19 outbreak.

The list includes Fauci, CDC director Robert Redfield, U.S. Food and Drug (FDA) commissioner Stephen Hahn and testing czar Adm. Brett Giroir.

The Senate Health, Education, Labor and Pensions committee is likely to question a number of recent moves within the various departments. Most notably, a recent memo by Azar required all new rules to pass through his office is likely to draw questions from legislators.

Meanwhile, the FDA is planning to expand the monitoring requirement for a vaccine, extending it to two months rather than the current one month.

This would extend the potential timeline for vaccines to be authorized or approved, but carries political implications as it would miss the Election Day deadline President Donald Trump has eagerly touted.

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