US CDC to decide who should get the new COVID shots

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SEPTEMBER 12, 2023

FILE PHOTO: People receive their second COVID-19 boosters in Waterford, Michigan.

A U.S. Centers for Disease Control and Prevention (CDC) advisory panel met on Tuesday to come up with a recommendation on whether updated COVID-19 shots approved by the government should be used broadly or targeted to specific at-risk populations, setting the stage for the launch of a re-vaccination campaign.

The CDC advisers are preparing to decide on whether to recommend that everyone ages 6 months and older receive a dose of the shots – and signaled that they were leaning toward such a broad use. The U.S. Food and Drug Administration (FDA) on Monday authorized updated COVID vaccines made by Pfizer and its German partner BioNTech as well as by Moderna. Novavax said the FDA was still reviewing its shot.

The shots are part of a push by public health officials to align the next COVID vaccines more closely with the actual circulating variant of the virus, much as annual flu shots are designed. A vaccination campaign is expected to be kicked off in the coming days.

Representatives from COVID vaccine manufacturers disclosed list prices for their shots at the ongoing meeting.

Pfizer/BioNTech have set the list price at $120 per dose for their shot. Moderna said its shot will be available at a price of $129 per dose. The list price for Novavax’s shot will be $130 per dose, and its contracted price will be $72.50 per dose.

In their presentation at the meeting, the advisers said they were supportive of a universal COVID-19 vaccine recommendation across age groups. The FDA approved the Pfizer/BioNTech and Moderna vaccines for people ages 12 and above, and authorized them for emergency use in children ages 6 months through 11 years.

At issue is whether the advisers will call for targeting specific populations for the shots – such as older adults and people with underlying medical conditions or compromised immune systems – or a campaign aimed at a broader population. CDC Director Mandy Cohen will make the final decision some time after the advisers make their recommendation.

The U.S. government ended the COVID public health emergency declaration in May and handed over the responsibility for vaccinations to the private sector.

AN EVER-EVOLVING VIRUS

Keeping up with the latest variants of the ever-evolving coronavirus has been a challenge for public health officials globally since the pandemic began in 2020, with some possessing more worrisome characteristics than others. Vaccines can be formulated to target specific variants. The variants circulating the most widely in the United States right now are subvariants of what is called the XBB lineage of the virus.

“I do think that a broad boosting strategy makes sense,” said Caitlin Rivers, a senior scholar at the Johns Hopkins Center for Health Security in Baltimore, adding that while the virus was not causing as many hospitalizations and deaths as before, it is still circulating.

COVID infections and hospitalizations have been rising in the United States, Europe and Asia but remain well below previous peaks. U.S. deaths are now relatively low – reported at around 2,000 last month – though the country has experienced 1.1 million COVID deaths since the outset of the pandemic.

The first COVID vaccines in 2020 were monovalent, or single-target vaccines, aimed at the original strain of the virus. They were followed by bivalent COVID vaccine booster shots that targeted both the original and the Omicron strains. The new updated shots are again monovalent, targeting what is called the XBB.1.5 variant, as requested by the FDA.

“I do think that the XBB.1.5 vaccine will provide better cross protection against the current Omicron variants than the bivalent booster,” said Dr. Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

Scientists are also closely watching other Omicron subvariants that are circulating including the currently dominant EG.5, nicknamed Eris, and the highly mutated BA.2.86 subvariant, that had raised concerns about a resurgence of infections.

Pfizer/BioNTech, Moderna and Novavax have said their updated shots are effective in protecting against the EG.5 subvariant, while Moderna and Pfizer’s shots generated strong responses in testing against the BA.2.86 subvariant. Novavax said on Monday it was still testing its vaccine against BA.2.86.


Courtesy/Source: Reuters