Covid-19 roundup: FDA shortens interval for Moderna booster dose to 5 months; Moderna CEO says another booster could be necessary this fall — report
The FDA has shortened the recommended interval between the primary series of Moderna’s Covid-19 vaccine and a booster shot to at least five months for adults.
The news comes days after the agency shortened the time interval between Pfizer and BioNTech’s primary series and booster to five months for children and adults 12 years and older. The FDA has also cleared a third dose of the Pfizer/BioNTech shot for certain kids ages five through 11 who are immunocompromised.
“The country is in the middle of a wave of the highly contagious omicron variant, which spreads more rapidly than the original SARS-CoV-2 virus and other variants that have emerged,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
Moderna CEO says another booster could be necessary this fall — report
While an Omicron-specific booster of Moderna’s Covid-19 vaccine probably won’t be ready in the next couple of months, according to a Reuters report, CEO Stéphane Bancel says another shot will likely be necessary for the fall.
“I still believe we’re going to need boosters in the fall of ’22 and forward,” Bancel said at a Goldman Sachs-organized event, per Reuters.
The news comes days after Israel Prime Minister Naftali Bennett announced that a study conducted in the country suggests a fourth Covid-19 vaccine dose spurs a five-fold increase in antibodies just a week after being administered.
Bancel said in a recent letter to investors that Moderna continues to evaluate variant-specific and multivalent vaccines (combinations of variant specific 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 a booster dose of its original vaccine, mRNA-1273, was enough to kick up Omicron neutralizing antibody levels dramatically. The currently authorized 50 µg booster increased Omicron-specific antibodies around 37-fold compared to pre-boost levels, researchers reported, while a 100 µg dose increased neutralizing antibody levels approximately 83-fold.
J&J touts real-world data supporting a single dose of its vaccine
The CDC recommended weeks ago that Americans receive one of the mRNA vaccines over J&J’s single-dose vaccine due to renewed concerns about blood clots. But the pharma giant isn’t backing down.
On Thursday, J&J unveiled new real-world data that suggest a single shot of its Covid-19 vaccine offered protection against breakthrough infections, hospitalizations, and ICU admissions for up to six months.
It’s important to note that data from the J&J-sponsored trial are preliminary, and have yet to be peer-reviewed. And they were collected before the Omicron variant was discovered.
One month post-vaccination, J&J reported efficacy rates of 81% for preventing hospitalization and 74% for preventing breakthrough infections. Over the course of six months, the pharma said there was no evidence of waning protection against hospitalizations or Covid-related ICU admissions. However, there was some “modest waning” of protection against breakthrough infections starting in month 4.
J&J noted that waning protection against breakthrough cases began in month 2 for both the Moderna and Pfizer/BioNTech shots.
The study was conducted using national claims, lab and hospital data for 17 million fully-vaccinated individuals between Jan. 1 and Sept. 7, 2021.
A few weeks ago, the CDC recommended against taking J&J’s shot if either the Pfizer/BioNTech or Moderna shot is available, over concerns about rare but sometimes fatal blood clots. J&J’s vaccine will still be available to those who are unable or unwilling to get an mRNA vaccine.
“We continue to undertake extensive efforts to study the durability of protection offered by the Johnson & Johnson vaccine amidst the ever-changing COVID-19 pandemic,” Mathai Mammen, Janssen’s executive VP of pharmaceuticals, said in a statement.
The FDA and CDC put a hold on J&J’s vaccine back in April to assess the risk of such blood clots but ended up lifting the pause less than two weeks later after deciding that the shot’s known and potential benefits still outweigh the risks.
But at an ACIP meeting, it was revealed that there are more cases of thrombosis with thrombocytopenia syndrome (TTS) in those who received the J&J vaccine than previously thought.
J&J put out a statement that it remains confident in the vaccine’s benefit-risk profile.