Pfizer vaccine for COVID-19.
Courtesy: Pfizer
The Food and Drug Administration on Thursday was approved updated covid vaccines from Pfizer and Modernputting the new plans on track to reach most Americans in the coming days amid a summer wave of the virus.
The jabs target a strain called KP.2, a descendant of the highly contagious micron subvariant JN.1 that began circulating widely in the US earlier this year. KP.2 was the dominant strain of Covid in May, but is now only due about 3% of all U.S. cases since Saturday, according to the latest data from the Centers for Disease Control and Prevention.
However, Pfizer and Moderna said the KP.2 vaccines can generate stronger immune responses against other circulating JN.1 subvariants, such as KP.3 and LB.1, than last year’s round of shots targeting the strain Omicron XBB.1.5..
“Given the waning immunity of the population from previous exposure to the virus and from previous vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against circulating variants,” said Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
In June, the CDC recommended that everyone over 6 months gets an up-to-date Covid and flu shot this year. The new shots from Pfizer and Moderna are specifically approved for people 12 years of age and older, and are approved for emergency use in children 6 months to 11 years of age.
Pfizer will begin shipping its new download immediately and expects it to be available in pharmacies, hospitals and clinics across the U.S. “beginning in the coming days,” the company said in a statement. Moderna expects its download to be available in the coming days, according to a statement.
“Staying up-to-date with your COVID-19 vaccine remains one of the best ways to protect people and prevent serious illness,” said Moderna CEO Stephane Bancel. “We appreciate the US FDA’s timely review and encourage individuals to talk to their healthcare providers about getting their updated COVID-19 vaccine along with their flu shot this fall.”
Type Moderna Covid-19 Vaccine mRNA 2024-2025.
Courtesy: Moderna
The FDA approval comes just weeks before last year’s round of shootings, which the agency cleared on 9/11.
The earlier arrival of updated vaccines could provide some reassurance to Americans as the nation sees a relatively large outbreak of the virus this summer. A ‘high’ or ‘very high’ level of Covid detected in wastewater in nearly every state, according to CDC data. The sewage monitoring provides a glimpse of how widespread the virus is in the US as other forms of testing have fallen flat.
Other measures of the virus are rising but remain well below where they were at the peak of the pandemic. Positive Covid test rates rose to 18.3 percent for the week ended Aug. 10, from 17.9 percent the previous week, according to the CDC.
Meanwhile, the CDC said about 4 people are hospitalized for Covid for every 100,000 people in a given area. That’s up from about 1 Covid hospitalization for every 100,000 people in May, which was the lowest level since the pandemic began.
The summer Covid wave may subside by the time the vaccines reach the hands of patients and initiate an immune response against the virus, which usually takes two weeks after vaccination.
But federal health officials have long told Americans to expect annual updates to Covid vaccines as the virus emerges in new strains that can evade immunity people have from previous vaccinations or infections — protection that weakens over time. It’s similar to how the US releases new flu shots every year.
It’s unclear how many Americans will actually roll up their sleeves to take another chance in the coming months.
Only about 22.5 percent of U.S. adults received the latest round of shots released last fall, according to CDC data until the beginning of May.
Many Americans who received previous rounds of Covid vaccinations cited a lack of concern about the virus as the reason they didn’t get the latest booster, according to a Nov. survey by the health policy research organization KFF. Others said they were too busy to drop them, the survey said.
In June, the FDA asked vaccine makers to make shots against JN.1 before telling them to target KP.2 instead “if feasible.”
This shift appeared to pose Novavaxwhich applied for approval of a new JN.1 shot in the same month, at a disadvantage. The FDA has not cleared the biotech company’s hit.
In a statement, Novavax said it is working “productively” with the FDA as the agency completes its review. Novavax expects its vaccine to receive approval in time for peak vaccination season in the US
The company noted that its shot provides protection against descendants of JN.1, including KP.2.3, KP.3, KP.3.1.1 and LB.1.
Novavax makes protein-based vaccines, which cannot be quickly updated to target another strain of the virus. The protein-based technology is a decades-old method used in routine hepatitis B and shingles vaccinations.
Meanwhile, Pfizer and Moderna’s shots use messenger RNA technology, which teaches cells how to make proteins that trigger an immune response against Covid. mRNA vaccines are much easier to develop and update than protein vaccines.
