Post by icemandios on Jun 15, 2023 23:34:08 GMT
While Uncle Lunch Box declared the Pandemic over on 5/11/23, and the WHO said the same a week or two earlier, the FDA is still granting EUAs for stuff. But that's not all.
VRBPAC unanimously recommends monovalent, XBB lineage for next fall's Covid-19 vaccine campaign
Zachary Brennan
Senior Editor
The FDA’s Vaccines and Related Biological Products Advisory Committee met Thursday to assess whether the Covid-19 vaccine needs to be updated, with the committee voting 21-0 in favor of a new monovalent, XBB lineage for shots likely coming this fall.
Pfizer/BioNTech, Moderna and Novavax all presented on what they are likely to have ready in the coming months, with all three vaccines potentially ready as soon as later this summer. Pfizer, for instance, noted that they could have an XBB.1.5 monovalent version available as soon as the end of next month, or an XBB.1.16 monovalent vaccine in August.
“Commercial manufacture of a monovalent XBB.1.5 vaccine is ongoing to support Fall 2023 availability,” Novavax added, and Moderna similarly said it is prepared to supply a new variant-containing vaccine for this fall too.
As these timelines came to light at the meeting, however, some panelists questioned who would receive this latest round of boosters and what data would be necessary prior to their release.
VRBPAC panelist Paul Offit of the Children’s Hospital of Philadelphia noted that the vaccines will be available in the next few months but “the data we don’t currently have” are “immunogenicity data or safety data for either Novavax or Pfizer” and “we don’t have concomitant use data for either influenza vaccine, which is likely to be given around the same time, or for older Americans, the RSV vaccine, and we don’t have dosing data for children.”
He questioned FDA on what standard they’re going to hold these companies to before the vaccines are made available, adding later before the vote, “I certainly think we need to update this vaccine” but “we need to know who benefits from booster dosing and it’s not everyone…this is not flu.”
Jerry Weir, director of FDA’s division of viral products office, said they expect extensive data packages from each of the manufacturers, but he could not offer any timelines on when some of those data might be available.
CBER director Peter Marks also told the committee there will likely be one update per year of the Covid vaccines, barring a dangerous strain that pops up and that requires mobilization and “tremendous resources.” He said that no one will disagree that there needs to be a better generation of vaccines, “but we’re here right now with what we have,” noting the next-gen vaccines are likely two years away.
Marks said the XBB.1.5 strain seems to be at the front of the line of what to include in the vaccine, as the manufacturers would have it ready in a timely manner, likely in September. Adcomm panelists generally agreed and did not have any strong opinions on including other strains.
Several panelists questioned the voting question presented and whether there needs to be a “periodic” update of the vaccines — the word “periodic” was later pulled from the voting question — or mentions of seasonality and Covid, although many agreed with Offit that an update now is necessary.
“I’m really having trouble understanding the committee’s need to bristle against something that’s similar to influenza,” Marks said, noting that the shot may not be yearly but in the fall of 2024 “there will be further drift from this and we may have to come back here. We have to do better because we have not done a good job to date communicating to the American public on what’s going on here.”
Marks also told the panel early in the meeting that vaccines can still be cleared under EUA, but “it is our intent though for adults as we move into this fall to the extent possible to move as many of these over to licensed products.” Novavax’s vaccine is still available under an EUA, whereas both the Pfizer/BioNTech and Moderna’s vaccines have won full approval.
Zachary Brennan
Senior Editor
The FDA’s Vaccines and Related Biological Products Advisory Committee met Thursday to assess whether the Covid-19 vaccine needs to be updated, with the committee voting 21-0 in favor of a new monovalent, XBB lineage for shots likely coming this fall.
Pfizer/BioNTech, Moderna and Novavax all presented on what they are likely to have ready in the coming months, with all three vaccines potentially ready as soon as later this summer. Pfizer, for instance, noted that they could have an XBB.1.5 monovalent version available as soon as the end of next month, or an XBB.1.16 monovalent vaccine in August.
“Commercial manufacture of a monovalent XBB.1.5 vaccine is ongoing to support Fall 2023 availability,” Novavax added, and Moderna similarly said it is prepared to supply a new variant-containing vaccine for this fall too.
As these timelines came to light at the meeting, however, some panelists questioned who would receive this latest round of boosters and what data would be necessary prior to their release.
VRBPAC panelist Paul Offit of the Children’s Hospital of Philadelphia noted that the vaccines will be available in the next few months but “the data we don’t currently have” are “immunogenicity data or safety data for either Novavax or Pfizer” and “we don’t have concomitant use data for either influenza vaccine, which is likely to be given around the same time, or for older Americans, the RSV vaccine, and we don’t have dosing data for children.”
He questioned FDA on what standard they’re going to hold these companies to before the vaccines are made available, adding later before the vote, “I certainly think we need to update this vaccine” but “we need to know who benefits from booster dosing and it’s not everyone…this is not flu.”
Jerry Weir, director of FDA’s division of viral products office, said they expect extensive data packages from each of the manufacturers, but he could not offer any timelines on when some of those data might be available.
CBER director Peter Marks also told the committee there will likely be one update per year of the Covid vaccines, barring a dangerous strain that pops up and that requires mobilization and “tremendous resources.” He said that no one will disagree that there needs to be a better generation of vaccines, “but we’re here right now with what we have,” noting the next-gen vaccines are likely two years away.
Marks said the XBB.1.5 strain seems to be at the front of the line of what to include in the vaccine, as the manufacturers would have it ready in a timely manner, likely in September. Adcomm panelists generally agreed and did not have any strong opinions on including other strains.
Several panelists questioned the voting question presented and whether there needs to be a “periodic” update of the vaccines — the word “periodic” was later pulled from the voting question — or mentions of seasonality and Covid, although many agreed with Offit that an update now is necessary.
“I’m really having trouble understanding the committee’s need to bristle against something that’s similar to influenza,” Marks said, noting that the shot may not be yearly but in the fall of 2024 “there will be further drift from this and we may have to come back here. We have to do better because we have not done a good job to date communicating to the American public on what’s going on here.”
Marks also told the panel early in the meeting that vaccines can still be cleared under EUA, but “it is our intent though for adults as we move into this fall to the extent possible to move as many of these over to licensed products.” Novavax’s vaccine is still available under an EUA, whereas both the Pfizer/BioNTech and Moderna’s vaccines have won full approval.
[The message appears to be "Be afraid, be very afraid. Oh, my emphasis was added to point out that, at least one was aware that emergency use authorizations have continued sans emergency. ]