FDA shortens interval for booster dose of Moderna to 5 months; Moderna CEO says another recall may be needed this fall – report – Endpoints News


The FDA has shortcut the recommended interval between the primary series of Moderna’s Covid-19 vaccine and a booster of at least five months for adults.

The news comes days after the agency shortened the time interval between the primary series and the recall of Pfizer and BioNTech to five months for children and adults 12 and older. The FDA has also cleared a third dose of the Pfizer / BioNTech vaccine for certain children aged five to 11 who are immunocompromised.

“The country is in the midst of a wave of the highly contagious omicron variant, which is spreading faster than the original SARS-CoV-2 virus and other variants that have emerged,” Peter Marks, director from the FDA’s Center for Biologics Assessment and Research, said in a statement.

Moderna CEO says another recall may be needed this fall – report

While a specific Omicron booster of Moderna’s Covid-19 vaccine is unlikely to be ready in the coming months, according to a Reuters report, CEO Stéphane Bancel says another shot will likely be needed for the fall.

“I still think we’ll need boosters in Fall 22 and beyond,” Bancel said at an event hosted by Goldman Sachs, according to Reuters.

The news comes days after Israeli Prime Minister Naftali Bennett announcement that a study in the country suggests that a fourth dose of Covid-19 vaccine stimulates a five-fold increase in antibodies just one week after being administered.

Bancel said in a recent letter to investors that Moderna continue to evaluate variant-specific and multivalent (variant-specific vaccine combinations) vaccines to stay ahead of future variants, including Omicron.

“In addition, we are evaluating mRNA-1283 as a next-generation refrigerator stable vaccine,” he wrote.

Just before the new year, Bancel revealed preliminary data suggesting that a booster dose of its original vaccine, mRNA-1273, was sufficient to dramatically increase the levels of Omicron neutralizing antibodies. The currently authorized booster of 50 µg increased Omicron specific antibodies by approximately 37 times over pre-boost levels, the researchers reported, while a dose of 100 µg increased levels of neutralizing antibodies about 83 times.

J&J touts real-world data supporting single dose of vaccine

The CDC recommended weeks ago that Americans receive one of the mRNA vaccines over J & J’s single-dose vaccine due to new concerns about blood clots. But the pharmaceutical giant is not backing down.

On Thursday, J&J unveiled new real world data who suggest that a single injection of his Covid-19 vaccine offered protection against infections, hospitalizations and intensive care admissions for up to six months.

It is important to note that the data from the J&J sponsored trial is preliminary and has not yet been peer reviewed. And they were collected before the discovery of the Omicron variant.

One month after vaccination, J&J reported efficacy rates of 81% for preventing hospital admissions and 74% for preventing onset infections. During the six months, pharma said there was no evidence of decreased protection against Covid-related hospitalizations or intensive care admissions. However, there was a “slight decline” in protection against breakthrough infections from month 4.

J&J noted that waning case protection began in month 2 for Moderna and Pfizer / BioNTech shots.

The study was conducted using national claims, laboratory and hospital data for 17 million people fully vaccinated between January 1 and September 7, 2021.

A few weeks ago, the CDC advised against taking J & J’s vaccine if the Pfizer / BioNTech or Moderna vaccine is available, due to concerns about rare but sometimes fatal blood clots. J & J’s vaccine will always be available for those who cannot or do not want to receive an mRNA vaccine.

Mathai Mammen

“We continue to make significant efforts to study the sustainability of the protection offered by the Johnson & Johnson vaccine amid the ever-evolving COVID-19 pandemic,” said Mathai Mammen, executive vice president of pharmaceuticals at Janssen , in a press release.

The FDA and CDC suspended J & J’s vaccine in April to assess the risk of such blood clots, but ended up lifting the hiatus less than two weeks later after deciding that the known and potential benefits of the vaccine still outweighed on the risks.

But at an ACIP meeting, it was revealed that there were more cases of thrombosis with thrombocytopenia syndrome (TTS) in people who received the J&J vaccine than previously thought.

J&J said he remains confident in the benefit-risk profile of the vaccine.