Anthony Fauci, on the suspension of the Johnson & Johnson vaccine due to cases of thrombosis: "It is an excess of caution."
The main epidemiologist of the White House said that the decision of the health authorities will allow "further investigation" of the reports in patients who received the formula from the North American laboratory, but recalled that there were only six episodes in 6.85 million doses applied.
The White House's chief epidemiologist, Dr. Anthony Fauci, gave a conference on Tuesday after the US Food and Drug Administration (FDA) recommended temporarily suspending vaccination with the Johnson & Johnson formula. Against the coronavirus after registering six cases of thrombosis in the country.
There have been 6 out of 6.85 million doses, which is less than 1 in 1 million. So remember, this is the product of an excess of caution", said the expert who served during the presidency of Donald Trump and continues now in functions in the administration of Joe Biden.
This decision was taken by the health authorities "allows both the FDA and the CDC to further investigate these cases to try to understand some more details about the history of the individuals who were involved," added Fauci.
For his part, he indicated that the review to be carried out by federal agencies might last "days or weeks", not months.
A meeting of health regulators will be held on Wednesday to analyze the data. We recommend this break until the process is complete. This is important to ensure that the healthcare provider community is aware of the potential for these adverse events and can plan for the one-time treatment required with these types of blood clots, "the FDA said in a statement.
The agency detailed that the six cases detected are of "a rare and serious type of blood clot in people after receiving the vaccine," which so far are "extremely rare."
Federal distribution channels, including large-scale vaccination centers, will temporarily suspend drug use, and states and other suppliers are expected to do the same. This is a precautionary measure to confirm whether or not there is a link between the formula and thrombosis cases.
With low platelet levels, all cases were found in female patients between the ages of 18 and 48, and these symptoms were recorded between six and 13 days after vaccination. One of the patients died in Nebraska, and the other was hospitalized with serious distress.
Experts suggest that people who have received the Johnson and Johnson vaccine in the last three weeks should contact their doctor if they have any of the following signs.: headaches, abdominal pain, leg pain, or shortness of breath.
Similar thrombotic cases have been reported in Europe with the Oxford / AstraZeneca vaccine. So far, the researchers have not ruled out a link with the vaccine, possibly an immune system reaction, but noted that the doses' benefits continue to outweigh the risks, especially in the older adult population. Days ago, The European Medicines Agency (EMA) said it is already investigating whether there was a link between the Johnson & Johnson vaccine and the formation of clots, days before it began to be applied in the Old Continent.
Jeff Zients, the coordinator of the government, said in a statement, The announcement will not significantly impact the vaccination plan, as the Johnson & Johnson vaccine still represents less than 5% of vaccines in the United States.
In the case of their vaccines, Pfizer and Moderna use messenger RNA, which is a kind of code that the vaccine delivers to cells. This code serves as an instruction manual for the vaccinated person's immune system to learn to recognize the coronavirus and attack it.
Clinical trials gave J&J vaccine efficacy of 66% in preventing moderate or severe disease in Phase 3 of a clinical trial in the United States and 85% in the most severe cases.
Pfizer's is effective in 95% of cases, with a similar response (94%) in cases of people over 65 years of age. Moderna has presented 94.5% effectiveness results in the United States.
Johnson & Johnson's vaccine has been licensed in the United States, the European Union (EU), and other countries.
Janssen Pharmaceutica, a division of Johnson & Johnson based in Belgium, developed the vaccine in collaboration with Israel's Beth Israel Deaconess Medical Center.