Jakarta, IDN Times – The United States Food and Drug Administration (FDA) took a decision on Friday (17/9) local time to offer the third COVID-19 vaccine only for people aged 65 years and over and most at high risk. Thus, the third vaccine is not intended for the general public.
1. The US has been pushing its partners to increase vaccine availability
Reported from Aljazeera.com, a US FDA advisory panel has approved Pfizer’s third COVID-19 vaccine for people over 65 and others at high risk.
But an influential panel of FDA scientists on Friday rejected widespread delivery of a third vaccine to most Americans, dealing a shocking blow to US President Joe Biden’s administration’s plans to combat the highly contagious Delta variant by launching a third vaccine next week.
Committee Chair, Dr. Arnold Monto, who is also an epidemiologist at the University of Michigan, continued the discussion after the vote.
Sixteen of the 18 advisers voted against a broad proposal for a third vaccine for those aged 16 and over, even as some members believed there was a role for a third vaccine.
Members of the FDA’s external expert panel voted unanimously in favor of a third vaccine for older US citizens and people at risk after rejecting Pfizer’s proposal to provide additional vaccines to the general public.
The FDA’s move to pave the way for a third vaccine only for the elderly and at risk comes as Biden plans to host a COVID-19 summit on the sidelines of the United Nations General Assembly in New York, USA, next week.
The US has been encouraging partner countries to increase the availability of vaccines worldwide. The World Health Organization (WHO) has urged the US to delay giving its citizens a third vaccine until more of the world’s population has received the initial vaccination.
White House Press Secretary Jen Psaki said she would ask participants to commit to a higher level of ambition to a shared vision of defeating the COVID-19 outbreak together.
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2. The decision comes after disagreements over the third vaccine
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The decision comes after significant public scientific disagreements over the third vaccine. Most of the supporting data come from Israel, while data is sparse on whether a third vaccine can help protect people from hospitalization and death.
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Member and professor of microbiology and immunology at the University of Michigan Medical School, Prof. A Oveta Fuller, said there were too many questions for her to feel comfortable saying “yes” to this.
Another committee member, Dr. Eric Rubin, who is also an assistant professor of microbiology and molecular genetics at Harvard, said he strongly suspected the vaccine would be low-risk, but he didn’t have one at this time and he didn’t think it would be convenient to give it to a 16-year-old for all the reasons everyone gave.
In its approval request, Pfizer submitted safety data for only about 300 adults aged 18-55 who received the third vaccine, a sample size that some members said was too small.
The decision calls into question the Biden administration’s plans to give a third Pfizer vaccine to fully vaccinated Americans over the age of 16.
In addition, the decision also calls into question the broader plan of impetus, which the government says is almost inevitable.
Another COVID-19 vaccine maker, Moderna, has applied for a third vaccine. Administration officials have not recommended additional vaccines for people receiving the Johnson & Johnson vaccine, although it is still possible.
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