- The US Food and Drug Administration approved the administration of a booster dose of the Pfizer/BioNTech vaccine in adults aged 65 years and above and others with a weak immune system.
- Johnson & Johnson requested for US FDA approval for booster dose to prevent Covid-19 infection in adults.
- AstraZeneca applied for the emergency FDA authorisation for the use of its COVID-19 antibody therapy.
Several studies have shown a decline in the effectiveness of the COVID-19 vaccine and a need for a booster dose to raise effectiveness and prevent further infection, especially in adults and immunocompromised patients. Vaccine manufacturers and regulatory bodies are currently evaluating the need and efficacy of booster vaccine doses.
Pfizer/BioNTech COVID-19 booster receives FDA approval
According to a study, six months after the second dose of the Pfizer Inc (NYSE: PFE) / BioNTech SE (NASDAQ: BNTX), the vaccine’s effectiveness declined to 47% from 88%. The study serves as important evidence in enabling the US health agencies to approve booster vaccines.
A previously published study in the Lancet medical journal reported that the vaccine’s effectiveness in preventing hospitalisations and deaths was 90% for a minimum period of six months. Pfizer vaccine’s effectiveness against the Delta coronavirus variant was known to be 93% post the first month of vaccination, which reduced to 53% after the fourth. For the other coronavirus variants, the vaccine efficacy declined from 97% to 67%.
The US Food and Drug Administration approved the administration of a booster dose of the Pfizer/BioNTech vaccine in adults aged 65 years and above and others with a weak immune system. Researchers are conducting further studies to decide upon the need for boosters for all individuals. The FDA is expected to authorise half-dose boosters of the Moderna COVID-19 vaccine, with the aim of widening the booster dose campaign in the US.
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J&J files for approval of booster vaccine
Johnson & Johnson (NYSE: JNJ) has requested US FDA approval for booster dose to prevent Covid-19 infection in adults. A late-stage clinical study revealed that a booster vaccine dose might offer 94% protection against the disease if administered 56 days after the first inoculation. FDA has scheduled a meeting to discuss potential boosters for Moderna Inc. (NASDAQ: MRNA) and J&J vaccines on 14 & 15 October.
EU committee recommends booster doses of Pfizer & Moderna vaccine
European Medicines Agency (EMA), an advisory committee in the European Union, recommended a third dose of Pfizer’s Covid-19 vaccine for all adults, after six months of taking their second vaccine dose; and Moderna’s COVID-19 booster vaccine dose only for immunocompromised people.
A booster dose of the Pfizer or Moderna vaccine, 28 days after the second shot in immunocompromised individuals, has also been recommended by the agency. Studies have proven that a booster dose can enhance the capability of antibodies production against the virus in organ transplant patients with declining or low immune systems.
AstraZeneca applies for approval of its monoclonal antibody therapy
AstraZeneca (LON: AZN) applied for the emergency FDA authorisation for the use of its COVID-19 antibody therapy - AZD7442 in patients who respond poorly to vaccines. The late-stage trial study in this regard is known to lower the risk by 77% to the people developing COVID-19 symptoms.
The AZD7442 contains laboratory-synthesised antibodies designed to remain in the body for months to prevent the infection by the virus. COVID-19 therapies based on the same monoclonal antibody class are also being developed by rival companies, including Eli Lilly, GlaxoSmithKline (LON: GSK) with partner Vir and Regeneron.