U.S. CDC Recommends mRNA COVID-19 Vaccines Over J&J's Jab
The U.S. Centers for Disease Control and Prevention prefers the use of PFE, BNTX and MRNA's mRNA-based COVID-19 vaccines instead of J&J's adenovirus-based vaccine due to higher risks of side...
The U.S. Centers for Disease Control and Prevention (“CDC”) endorsed updated recommendations made by the Advisory Committee on Immunization Practices (ACIP) preferring Pfizer PFE and Moderna’s MRNA COVID vaccines over J&J’s JNJ.
The CDC now prefers the use of mRNA-based COVID-19 vaccines — Pfizer and BioNTech’s BNTX Comirnaty, and Moderna's mRNA-1273 (Spikevax) — or their booster dose over authorized adenovirus-based vaccine in the United States — J&J single-shot COVID-19 vaccine. The CDC stated that J&J’s vaccine or its booster dose should be used only when mRNA-based vaccines are contraindicated for a person or are inaccessible.
The ACIP recommendation, preferring Pfizer and BioNTech’s Comirnaty or Moderna’s mRNA-1273 over J&J’s vaccine, was based on discussions of the latest evidence on vaccine effectiveness, vaccine safety and rare adverse events as well as the available supply of vaccines in the United States.
The ACIP observed that the administration of adenovirus-based COVID-19 vaccine could lead to higher risk of fatal side effects, including rare cases of thrombosis with thrombocytopenia syndrome (TTS) and even deaths. The advisory committee reported nearly 15% mortality for TTS cases following immunization with J&J’s COVID-19 vaccine and 17% of TTS cases required post-acute care/rehabilitation facility. Vaccination with J&J’s COVID-19 vaccine also led to rare cases of Guillain-Barré syndrome (“GBS”), a rare disorder in which the immune system attacks the nerves. Among the total GBS cases, nearly 1% of the patients died and 10% required mechanical ventilation.
Regulatory bodies across the world, especially in the United States and Europe, have created systems to continuously monitor the effects of COVID-19 vaccines following their administration. These systems have been created to assess the benefit-risk profile of the vaccines, which were developed and authorized at a much faster pace than any drug or vaccine for other indications. Vaccination with either mRNA-based vaccines or adenovirus-based vaccines, which also includes AstraZeneca’s AZN COVID-19 vaccine, has resulted in rare cases of myocarditis and blood clots, respectively, in the past year.
The cases of TTS, as reported by European Union, following vaccination with AstraZeneca’s vaccine were higher than J&J’s vaccine. The TTS cases occurred mostly after the first dose of AstraZeneca’s COVID-19 vaccine. Unlike J&J, AstraZeneca’s vaccine is available in a two-dose regimen. The cases of TTS per million have increased following the administration of AstraZeneca’s COVID-19 vaccine since April.
Meanwhile, there have been rare cases of myocarditis after the administration of Pfizer and BioNTech’s Comirnaty or Moderna’s mRNA-1273. However, there have been no cases of deaths. More than 50% of cases had no symptoms and more than 90% recovered fully after three months of the onset of myocarditis.
The death cases and higher occurrences of side effects led the ACIP to recommend mRNA-based vaccines over J&J’s COVID-19 vaccine. We note that the FDA also updated EUA fact sheets for J&J’s vaccine. The vaccine is now contraindicated for use in individuals who have previously suffered from TTS after vaccination with J&J’s COVID-19 vaccine or any other adenovirus-based COVID-19 vaccine.
J&J’s Vaccine Halted Previously
Please note that the use of J&J’s COVID-19 vaccine was halted in the United States in April to investigate blood clotting issues following the administration of the vaccine. However, the administration was re-initiated for the vaccine after ten days as regulatory authorities considered the risk of TTS to outweigh the benefits of the vaccine. Updated monitoring data showed that cases of deaths from TTS have not declined since April.
J&J defended its COVID-19 vaccine following the updated ACIP recommendation. The company remains confident that the vaccine has an overall positive benefit-risk profile. It stated that the vaccine demonstrated strong and long-lasting effectiveness in clinical studies. The vaccine also demonstrated robust effectiveness of both homologous and heterologous administration of its booster dose in providing protection against COVID-19 infection. J&J also believes that its single-dose administration, along with ease of storage and transport, makes the vaccine a better option. The company hopes that its vaccine can be a critical tool to fight COVID-19 in low- and middle-income countries.
While J&J, Moderna, Pfizer and BioNTech carry a Zacks Rank #3 (Hold), AstraZeneca carries a Zacks Rank of 4 (Sell).
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