GSK to Compensate for Merck's Pediatric HepB Vaccine Shortage

April 11, 2018 08:44 am Chris Crawford

Merck & Co. Inc. has announced that because of a continuing manufacturing issue, its shortage of pediatric hepatitis B (HepB) recombinant vaccine (Recombivax HB) will continue through the rest of 2018.

[physician with tablet, HBV text]

On its Current Vaccine Shortages & Delays webpage,(www.cdc.gov) the CDC said GlaxoSmithKline will mitigate the shortage of pediatric HepB vaccines with supply to meet full demand in the United States.

GSK will do so using its monovalent pediatric HepB vaccine (Engerix-B Pediatric) and its diphtheria, tetanus toxoids and acellular pertussis (DTaP); HepB; and inactivated polio vaccine (IPV) pediatric combination vaccine (Pediarix).

Merck hasn't distributed its pediatric HepB vaccine since mid-2017 and has informed the CDC that it will have only a limited supply available for the rest of the year.

The combined supply from the two manufacturers should account for about 90 percent of the amount of monovalent pediatric HepB vaccine normally available for the rest of 2018, said the CDC.

Story Highlights
  • In the face of a shortage of Merck's pediatric hepatitis B (HepB) vaccines, the CDC has said GlaxoSmithKline (GSK) will fill in with sufficient supply to meet full U.S. demand.
  • GSK will do so using its monovalent pediatric HepB vaccine and its diphtheria, tetanus toxoids and acellular pertussis; HepB; and inactivated polio vaccine pediatric combination vaccine.
  • In clinical guidance updated on April 6, the CDC said health care professionals should continue to follow the agency's 2018 childhood and adolescent immunization schedule for recommendations about the pediatric HepB vaccine.  

"The expected monovalent supply will provide sufficient vaccine to cover the hepatitis B birth dose for all children, as well as additional pediatric hepatitis B vaccine for second and third doses," the agency said.

However, the CDC said health care professionals will still need to make adjustments because of the shortage of monovalent vaccine.

"To ensure an equitable distribution of monovalent hepatitis B vaccine and direct vaccine doses according to the CDC's clinical guidance,(www.cdc.gov) the CDC will implement controlled vaccine ordering in the public sector using both Merck's and GSK's monovalent pediatric hepatitis B vaccines," the agency reported.

Additionally, the CDC said GSK will offer monovalent doses directly to the private sector market using a plan that would control ordering and target the monovalent HepB vaccine consistent with the CDC's clinical guidance. The company also will offer its DTaP-HepB-IPV pediatric combination vaccine to both public and private sector markets.

Pamela Rockwell, D.O., the AAFP's liaison to the CDC's Advisory Committee on Immunization Practices (ACIP), told AAFP News the biggest takeaway from this news is that the ACIP's recommendations for pediatric HepB vaccine administration have not changed.

"Family physicians should be reassured that GSK is taking over manufacturing the supply of pediatric HepB vaccine that's needed," she said.

Pediatric HepB Guidance

In its April 6 clinical guidance, the CDC said health care professionals should continue to follow the CDC's immunization schedule for children and adolescents for recommendations about the pediatric HepB vaccine.

Those recommendations include using only a single-component HepB vaccine for any dose given before age 6 weeks, including the birth dose; DTaP-HepB-IPV should not be administered before age 6 weeks.

The CDC also recommends a minimum age of six months for the final (third or fourth) dose of the HepB vaccine.

It should be noted that family physicians using the DTaP-HepB-IPV vaccine can continue vaccinating with no changes, because the supply of that vaccine is sufficient to support current immunization recommendations.

For vaccine series started with a single-component vaccine, combination vaccines can be used to complete the series. Family physicians using the single-component vaccine need to remember that the third dose of the HepB vaccine is recommended at age 6-18 months.

"When vaccinating healthy infants born to hepatitis B surface antigen-negative mothers, single-component HepB vaccine may be administered later within the timeframe recommended for the third dose," the CDC's clinical guidance noted.

For populations with high rates of childhood HepB infection, the final dose should be administered at age 6-12 months.

If mothers are HepB surface antigen-positive or have an unknown HepB status, their infants should complete the pediatric HepB vaccine series within the first six months, followed by serologic testing. Also, HepB immune globulin may be recommended immediately after birth in addition to the pediatric HepB vaccine if a mother is HepB surface antigen-positive.

Adult HepB Vaccine Shortage

Curious family physicians should know that like its pediatric HepB vaccine formulation, Merck also isn't currently distributing its adult HepB recombinant vaccine (Recombivax HB) and doesn't expect to do so the for remainder of 2018, the CDC said.

"GSK has sufficient supplies of adult hepatitis B vaccines (Engerix-B Adult) to address the anticipated gap in Merck's supply of adult hepatitis B vaccine during this period," the agency said.

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