<p>US President's Joe Biden's plans to administer a booster dose to those in America above 16 years of age came to a halt after the Food and Drug Administration (FDA) early Saturday after a panel voted 16-2 against the proposal.</p>.<p>This is the second setback to Biden after the CDC had ruled out a Moderna booster shot last month. However, the FDA panel voted 18-0 in favour of approving the Pfizer booster shot for people aged 65 and above.</p>.<p><strong>Also Read | <a href="https://www.deccanherald.com/international/covid-19-booster-shot-debate-heats-up-amid-breakthrough-infections-1031604.html" target="_blank">Covid-19 booster shot debate heats up amid breakthrough infections</a></strong></p>.<p>Here's five reasons why the FDA refused to approve the booster doses for the general US population</p>.<p><strong>Insufficient data</strong></p>.<p>The FDA panel said that a clincial of trial consisting just over 300 participants was not enough to make a conclusion over the booster dose's safety for all above 16. Much of the data has been focussed on those above 60 years of age. The immune response to a booster dose differs between someone a sexagenarian and a teenager.</p>.<p><strong>Concerns over evidence</strong></p>.<p>Dr Philip Krause, director of the FDA's Office of Vaccines Research and Review, was quoted as saying by <em>CNN</em> that data being presented and discussed was <a href="https://edition.cnn.com/2021/09/17/health/fda-advisers-booster-five-things/index.html" target="_blank">neither "peer-reviewed"</a> nor verified by the medical body.</p>.<p>Another official <a href="https://edition.cnn.com/2021/09/17/health/fda-advisers-booster-five-things/index.html" target="_blank">noted</a> that Pfizer's study only focused on the presence of antibodies and ignored other key immune responses.</p>.<p><strong>Not everyone, only a specific target needs</strong></p>.<p>Another reason for the FDA panel's verdict was that the general population comprising healthy individuals simply did not need a third dose of the vaccine since the first two doses offered sufficient protection against the virus. This, coupled with a risk of myocraditis — an inflammation of the heart muscle that inhibits normal flow of blood — led to their rejection of President Biden's proposal.</p>.<p><b>Many yet to get vaccinated</b></p>.<p>With the US having vaccinated 53.69 per cent of its population with both doses and 9.17 with only one (according to figures from our world in data), experts felt that the need for a booster dose for the general population was not necessary until more more individuals are fully vaccinated.</p>.<p><strong>It's a bit too soon</strong></p>.<p>The US, which began its vaccination drive in December last year, has vaccinated over half of its target population. Only a small fraction of the population would be eligible for booster dose, given that it must be taken eight months after the second dose according to CDC guidelines.</p>.<p><strong>Check out latest DH videos here</strong></p>
<p>US President's Joe Biden's plans to administer a booster dose to those in America above 16 years of age came to a halt after the Food and Drug Administration (FDA) early Saturday after a panel voted 16-2 against the proposal.</p>.<p>This is the second setback to Biden after the CDC had ruled out a Moderna booster shot last month. However, the FDA panel voted 18-0 in favour of approving the Pfizer booster shot for people aged 65 and above.</p>.<p><strong>Also Read | <a href="https://www.deccanherald.com/international/covid-19-booster-shot-debate-heats-up-amid-breakthrough-infections-1031604.html" target="_blank">Covid-19 booster shot debate heats up amid breakthrough infections</a></strong></p>.<p>Here's five reasons why the FDA refused to approve the booster doses for the general US population</p>.<p><strong>Insufficient data</strong></p>.<p>The FDA panel said that a clincial of trial consisting just over 300 participants was not enough to make a conclusion over the booster dose's safety for all above 16. Much of the data has been focussed on those above 60 years of age. The immune response to a booster dose differs between someone a sexagenarian and a teenager.</p>.<p><strong>Concerns over evidence</strong></p>.<p>Dr Philip Krause, director of the FDA's Office of Vaccines Research and Review, was quoted as saying by <em>CNN</em> that data being presented and discussed was <a href="https://edition.cnn.com/2021/09/17/health/fda-advisers-booster-five-things/index.html" target="_blank">neither "peer-reviewed"</a> nor verified by the medical body.</p>.<p>Another official <a href="https://edition.cnn.com/2021/09/17/health/fda-advisers-booster-five-things/index.html" target="_blank">noted</a> that Pfizer's study only focused on the presence of antibodies and ignored other key immune responses.</p>.<p><strong>Not everyone, only a specific target needs</strong></p>.<p>Another reason for the FDA panel's verdict was that the general population comprising healthy individuals simply did not need a third dose of the vaccine since the first two doses offered sufficient protection against the virus. This, coupled with a risk of myocraditis — an inflammation of the heart muscle that inhibits normal flow of blood — led to their rejection of President Biden's proposal.</p>.<p><b>Many yet to get vaccinated</b></p>.<p>With the US having vaccinated 53.69 per cent of its population with both doses and 9.17 with only one (according to figures from our world in data), experts felt that the need for a booster dose for the general population was not necessary until more more individuals are fully vaccinated.</p>.<p><strong>It's a bit too soon</strong></p>.<p>The US, which began its vaccination drive in December last year, has vaccinated over half of its target population. Only a small fraction of the population would be eligible for booster dose, given that it must be taken eight months after the second dose according to CDC guidelines.</p>.<p><strong>Check out latest DH videos here</strong></p>