US Evidence and equity, not politics, should guide booster shots

14:05  08 september  2021
14:05  08 september  2021 Source:   thehill.com

Biden’s Booster Plan Seen Facing CDC, FDA Resistance

  Biden’s Booster Plan Seen Facing CDC, FDA Resistance Medical experts who advise U.S. regulators on vaccines are chafing at what they perceive as political interference in the review process by the Biden administration. © Bloomberg A Senior Living Facility Administers A Third Covid-19 Dose To Residents Last month, the White House announced plans to begin distributing Covid-19 booster shots to Americans Sept. 20. However, the effort still needs the Food and Drug Administration and the Centers for Disease Control and Prevention to sign off.

Nearly a year ago, political pressure on the Food and Drug Administration and Centers for Disease Control and Prevention to swiftly authorize and recommend COVID-19 vaccines was so immense that it threatened the trust in and integrity of the rollout before it even began. Fortunately, those agencies and their respective independent advisory boards - America's last line of defense for a safe vaccine - were ultimately able to fulfill their responsibilities properly and independently, leading to the authorization and distribution of safe and effective vaccines.

Evidence and equity, not politics, should guide booster shots © Getty Images Evidence and equity, not politics, should guide booster shots

As the Biden administration readies a plan for COVID-19 booster shots, we must heed past lessons and ensure the authorization process can run its proper course.

WHO Director Criticizes 'Vaccine Nationalism,' Again Asks Countries to Forgo Booster Shots

  WHO Director Criticizes 'Vaccine Nationalism,' Again Asks Countries to Forgo Booster Shots WHO Director-General Tedros Adhanom Ghebreyesus told reporters in Budapest, Hungary, that he was "really disappointed" with the global distribution of vaccines.WHO Director-General Tedros Adhanom Ghebreyesus said while speaking to reporters in Budapest, Hungary, that he was "really disappointed" with the global distribution of vaccines as poorer countries are unable to provide many with even one dose and wealthier countries are preparing to roll out booster shots.

The federal government and state and local public health departments are wise to plan for the potential authorization of boosters. But arbitrary timelines are not the answer. Reports indicate that the administration now recognizes its planned Sept. 20 rollout date for boosters to the general public is premature.

The FDA's independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Sept. 17 to consider the latest boosters data, but it is unlikely that all clinical trial data from all approved or authorized vaccines will be available by then. Moreover, if and when VRBPAC makes boosters recommendations, several additional steps must follow prior to any boosters being administered. Those steps include the FDA formally amending current vaccine authorizations or approvals; the CDC's Advisory Committee on Immunization Practices (ACIP) making recommendations on who should receive boosters, and in what order; and the CDC formally signing off on ACIP's recommendations.

The U.S. plans to offer booster shots next month. Some health experts are wary.

  The U.S. plans to offer booster shots next month. Some health experts are wary. Officials said data showing decline in vaccines' protection against the Delta variant prompted the decision.The Biden administration plans to begin offering Covid-19 booster shots to all American adults starting Sept. 20, amid growing evidence that a third dose of the vaccine will be needed to maintain immunity against the virus.

The latest research confirms that COVID-19 vaccines are incredibly effective for at least six months at preventing severe disease resulting in hospitalization. Some evidence does show that vaccine protection against overall infection may wane to some degree beyond then, particularly for high-risk populations like nursing home residents and frontline healthcare workers. A joint statement from representatives of agencies under the Department of Health and Human Services states that "the current protection against severe disease, hospitalization, and death could diminish in the months ahead." What isn't yet clear, however, is whether this is due exclusively to a time-dependent decline in protection or the emergence of the highly contagious Delta variant as the dominant strain in the United States.

At least for some, boosters may be warranted eventually. But there is more data to come that VRBPAC and ACIP have not yet considered that will inform subsequent recommendations.

COVID-19 vaccine booster guidance will come down to the wire to meet Biden's goal

  COVID-19 vaccine booster guidance will come down to the wire to meet Biden's goal As early as Sept. 20, vaccinated Americans could start to get booster doses of COVID-19 vaccine. Who will be eligible at first is still being decided.That leaves little reaction time for health care system administrators like Dr. Tammy Lundstrom, chief medical officer for Michigan-based Trinity Health, which operates 92 hospitals and 120 continuing care facilities in 22 states.

The FDA and CDC have already determined that third shots are necessary for the severely immunocompromised who derived little or no protection from their initial shots. But that does not mean boosters are necessarily coming for everyone, certainly not all at once. Indeed, at its most recent meeting, multiple ACIP members cautioned that if boosters are eventually authorized, they may initially only go to highest-risk populations.

As a former ACIP member, I can attest to the importance of allowing these deliberations to proceed - not only to ensure that recommendations are built on the totality of evidence, but also so that the American people can trust the end results. Given the overwhelming politicization of the pandemic response, and the deep vaccine skepticism in large segments of the population, any further erosion of trust would be deeply harmful.

Boosters notwithstanding, our main focus should be inoculating the unvaccinated, as they account for the overwhelming majority of COVID-19 cases, hospitalizations and deaths. After a steep decline from last spring, vaccination rates are beginning to rise again; the seven-day average of new vaccines administered daily in the U.S. has risen from just over 500,000 in early July to more than 950,000 on Sept. 3. The FDA's recent decision to grant full approval for Pfizer's vaccine should help rates rise further still.

Overnight Health Care — Nicki Minaj stokes uproar over vaccines

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Nevertheless, tens of millions of eligible U.S. residents are not vaccinated, and some groups that have been disproportionately affected by the pandemic are still lagging behind. In about half of reporting states, per the Kaiser Family Foundation,"Black people have received smaller shares of vaccinations compared to their shares of cases and the total population." Lack of vaccine accessibility - particularly among those with low incomes or disabilities - is still a major barrier for some people.

And given that boosters would mean further tapping into our vaccine supply at home, we must recognize that we are falling woefully short on vaccine equity around the globe. One analysis finds that "countries and regions with the highest incomes are getting vaccinated more than 20 times faster than those with the lowest." Vaccines administered in low-income countries account for 0.3 percent of vaccines administered globally. Among nations with more than 100,000 people, at least 50 of them have less than 10 percent of their populations fully vaccinated.

The United States has committed to donating at least 500 million vaccines globally, but that must be a first step, not a final one. The concentration of vaccines among wealthy and powerful nations is unwise and immoral. A proposal from the International Monetary Fund to end the COVID-19 pandemic is built on achieving a vaccination rate of at least 40 percent in every country by the end of 2021 and at least 60 percent by the first half of 2022. The $50 billion cost of such a plan would be far outweighed by the estimated $9 trillion in resulting health and economic benefits. But we are nowhere near achieving those metrics. Our collective and ongoing failure to vaccinate the world guarantees that the coronavirus - and, potentially, even more severe variants in the future - will continue to find safe haven.

U.K. Defies WHO, Recommends COVID Booster Shots for Those Over 50

  U.K. Defies WHO, Recommends COVID Booster Shots for Those Over 50 The WHO has repeatedly called on richer countries to delay booster vaccines until 40 percent of the every country's population is vaccinated.Health Secretary Sajid Javid said the government accepted the recommendation of the Joint Committee on Vaccination and Immunization to offer booster shots after an expert panel said they were needed to protect against vaccines beginning to lose efficacy this winter.

In some countries, widespread booster rollouts have already begun; whether that happens in the U.S. will be revealed over time. As additional data and evidence come in, we would do well to remember that any decisions on boosters must be based on recommendations from the scientific community. In the meantime, we must redouble our efforts to get first and second shots to people here and around the world who have had none, for that is ultimately the key to ending this pandemic for good.

Julie Morita is executive vice president of the Robert Wood Johnson Foundation and served on President Biden's COVID-19 Advisory Board during the transition. She was formerly medical director, chief medical officer and commissioner of the Chicago Department of Public Health. Twitter:@DrJulieMorita.

Why the FDA made the right call on Covid booster shots .
Protecting already vaccinated Americans from contracting mild Covid shouldn't be more important than the lives and human rights of people in poorer countries.The idea of ramping up booster shots has come under sharp criticism from scientific authorities around the globe, including the director-general of the World Health Organization and leading journals such as Nature and Science, due to extreme global vaccine inequity and the unclear benefits of providing booster shots on such a wide scale. Hopefully the decision on Friday, though not binding, will cause Biden to rethink his plans.

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