In Johnson & Johnson’s most recent clinical trial, researchers found that receiving two doses of the vaccine provided 94% efficiency against contracting coronavirus.
Previously, Johnson & Johnson single dose had an 85% efficiency. The new clinical trial, compared the immunity of 32,000 volunteers who received one dose of Johnson & Johnson to those who received two doses eight weeks apart.
The Johnson & Johnson vaccine was issued under Emergency Use Authorization.
States of Clinical Trials
There are six stages of Clinical Trials in America.
- Phase I Trial
- Phase II Trial
- Phase III Trial
- Drug Application Review / FDA Approval
- Phase IV / Post-marketing
Summaries of various Clinical Trial Phases, and the goals of each stage explained:
Phase 1 Booster Trials:
“We have established that a single shot of our COVID-19 vaccine generates strong and robust immune responses that are durable and persistent through eight months. With these new data, we also see that a booster dose of the Johnson & Johnson COVID-19 vaccine further increases antibody responses among study participants who had previously received our vaccine,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “We look forward to discussing with public health officials a potential strategy for our Johnson & Johnson COVID-19 vaccine, boosting eight months or longer after the primary single-dose vaccination.”
Phase 3 Booster Trials:
“Our large real-world evidence and Phase 3 studies confirm that the single-shot Johnson & Johnson vaccine provides strong and long-lasting protection against COVID-19-related hospitalizations. Additionally, our Phase 3 trial data further confirm protection against COVID-19-related death,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “Our single-shot vaccine generates strong immune responses and long-lasting immune memory. And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the strength of protection against COVID-19 further increases.”
“It is critical to prioritize protecting as many people as possible against hospitalization and death given the continued spread of COVID-19. A single-shot COVID-19 vaccine that is easy to use, distribute and administer, and that provides strong and long-lasting protection is crucial to vaccinating the global population,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “At the same time, we now have generated evidence that a booster shot further increases protection against COVID-19 and is expected to extend the duration of protection significantly.”
Data from Phase 3 Trails show Booster shot at two months provided 94 percent protection against COVID-19 in the U.S.
The Phase 3 “ENSEMBLE 2” study showed that a second injection of Johnson & Johnson’s COVID-19 concoction given 56 days after the first injection provides:
- 100% protection (CI, 33%-100%) against severe/critical COVID-19 – at least 14 days post-final vaccination.
- 75% protection against symptomatic (moderate to severe/critical) COVID-19 globally (CI, 55%-87%).
- 94% protection against symptomatic (moderate to severe/critical) COVID-19 in the U.S. (CI, 58%-100%).
The newly reported data shows the second shot raised the antibody level in the blood of volunteers four times higher than levels produced by the first shot.
This data has been submitted to the Food and Drug Administration (FDA), Johnson & Johnson said. Since the company received Emergency Use Authorization in February, 14.6 million people in the United States have received its one-shot vaccine.
The next stage after Phase 3 Clinical Trial Testing is FDA Drug Application Review, and FDA Approval. Johnson & Johnson has already released a preprint study conducted by the researchers.
This study was funded by Janssen R&D.
As competing pharmaceutical companies race through the Clinical Trial process, many Americans are left wondering who is benefitting from these booster vaccines. Isreal’s data fails to show how the Pfizer-BioNTech booster vaccines are even effective. Could “booster shots” just be another way to gain funding and revenue for major pharmaceutical companies?