Biden: My winter plan fights COVID with testing and vaccines and without lockdowns

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https://www.usatoday.com/story/opin...ovid-vaccines-omicron-winter-plan/8827606002/

OPINION This piece expresses the views of its author(s), separate from those of this publication.
President Biden: My winter plan fights COVID with testing and vaccines and without lockdowns
Joe Biden
President of the United States
Published 6:17 pm ET Dec. 2, 2021

I know that Americans are exhausted from COVID-19 and want to know when it will end, and the new variant is adding to that unease. I get it.

I pledged to always be straight with the American people and tell you the truth. Here’s the truth about the new omicron variant: While it is a cause for concern, it is not a cause for panic. Experts say that COVID-19 cases will continue to rise in the weeks ahead this winter, and that we will see more omicron cases here in the United States in the days, weeks and months ahead. Our best scientists and doctors are on the case and gathering data, but early indications are that our vaccines will provide a measure of protection against this strain. We have the tools to protect ourselves and battle this virus, and I’m laying out a plan to do just that this winter.

We are going to fight COVID-19 not with shutdowns or lockdowns – but with more widespread vaccinations, boosters, testing and more. We will beat it back with science and speed, not chaos and confusion – just as we did in the spring and again with the more powerful delta variant in the summer and fall.

There are six key actions in my plan for this winter.

Boosters, testing at the forefront
►All adults should get a booster shot six months after they got vaccinated (or two months after, if you were vaccinated with Johnson & Johnson). Right now, most adults in this country who are eligible for boosters still have not gotten their booster shot. We are expanding our nationwide booster campaign with more appointments, more hours – including nights and weekends – and more walk-ins. To spread the word, pharmacies will send millions of texts and emails to remind their customers. My administration will also contact the more than 60 million people on Medicare. And, to reach their 38 million members, we’ll join town halls and events hosted by AARP, which is also offering seniors free rides to boosters.

►We are expanding our efforts to vaccinate children ages 5 and up and keep our schools open. To replace the mass vaccination sites for adults we had earlier in the year with a more comfortable setting for families and children, we will launch hundreds of new family vaccination clinics to make it easier for children, parents and whole families to get vaccinated in one place. These sites will be at community health centers and other trusted locations – and even some mobile sites to reach hard to reach communities.

Today, over 99% of schools are open, and we need to make sure we keep it that way this winter. While vaccinating our kids is critical to keeping our schools open, the Centers for Disease Control and Prevention is also reviewing new approaches to keep our children in school instead of quarantining at home.

►We are making free at-home tests available. Thanks to our actions, there are now at least eight at-home testing options available. Prices for these tests are decreasing. But it’s not enough. My administration is requiring that health insurers cover the cost of at-home testing. If you are one of the 150 million Americans on private health insurance, at-home tests will be covered by your insurance. And, if you’re not covered by private insurance, we will make free tests available for pickup at thousands of sites nationwide.

Medical initiatives part of plan, too

►We will increase “Surge Response Teams” – the doctors, nurses, and medical staff that go into communities with rising cases and help overburdened hospitals. Since summer, we have worked with Republican and Democratic governors to deploy Surge Response Teams in response to the delta variant. These teams worked in communities struggling with surges, and we’ll more than double the number of teams this winter.

►We are increasing the availability of new medicines, including monoclonal antibody treatments that have been shown to reduce the risk of hospitalization. We also may soon have promising new antiviral pills that could help prevent hospitalization and death of people infected by COVID-19. If approved, we will ensure that these new medicines are available in the hardest-hit communities.

►In order to beat this pandemic at home, we have to beat this pandemic globally. COVID-19 and the delta and omicron variants have all emerged in other parts of the world before coming here. We must vaccinate the world and strengthen international travel rules for people coming into the U.S. We have already shipped for free 280 million vaccines – more vaccines to other countries than all other countries combined. We will accelerate the delivery of more vaccines – 200 million more doses in the next 100 days. And, all international travelers entering the U.S. must test within one day of departure. This tighter testing timeline will help slow the spread of the virus.

We’ve been doing everything we can to beat this virus. And, that’s what we have to keep doing. We can and we must come together as a nation to fight this virus, to protect one another, to protect our economic recovery. We moved forward in the face of COVID-19 and the delta variant. And, we will move forward now at the start of winter and in the face of the omicron variant – together.

Joe Biden is the 46th president of the United States.

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just trying to keep @Sweet Lou 4 2 happy

 

https://www.washingtonpost.com/outlook/2021/12/16/vaccines-fda-cdc-boosters-expert-panel/

The Biden administration has been sidelining vaccine experts
The FDA, for example, approved booster shots for 16- and 17-year-olds without convening a key advisory panel

By Philip R. Krause and Luciana Borio
Today at 8:19 a.m. EST

The U.S. government, over the past few weeks, has made three important decisions on vaccines without consulting independent panels of experts. On Nov. 19, the Food and Drug Administration authorized boosters for all adults — regardless of their job or any underlying health conditions. On Nov. 29, the Centers for Disease Control and Prevention announced that everyone 18 and above should get a booster shot, a revision of previous guidance that strongly recommended boosters only for those 50 and older. Then, on Dec. 9, the FDA authorized booster shots (of Pfizer) for 16- and 17-year-olds, moving the age of eligibility down from 18.

Before last month, the standard practice was for the agencies to convene standing outside advisory committees, whose members inspect the relevant data, debate it and vote. That did not happen in these cases, meaning that the costs and benefits of these policy moves, from a medical perspective, were not fully aired publicly and discussed in advance.

One of us is the former deputy director of the FDA’s Office of Vaccines Research and Review; the other is a former acting chief scientist at the FDA. We believe that much is lost when decisions like these are made without consulting outside experts — whatever one believes about the merits of the policies in question.

At this point in the pandemic, the world faces a host of new questions related to vaccines and boosting. The recommendations of experts on the outside advisory committees are needed more than ever — so the scientific community can understand the empirical bases for decisions, and so the public can be assured that science, not politics, is driving vaccine policy.

In each of the recent decisions we’ve mentioned, at least some experts would probably have voiced opposition (based on earlier scientific debates and votes the two committees had taken, which supported different conclusions). That these experts were not given a chance to make their cases could hurt the credibility of these agencies. (In a poll published in May, conducted by the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health, some 75 percent of American adults said they trusted the FDA a great deal or somewhat, with 24 percent saying they felt not much trust or none. The rest of the respondents refused to answer or had no opinion.)

This area of research is fast-moving, and much changed between the most recent meetings of the expert committees (on the booster question) and the FDA’s decision to authorize boosters for 16- and 17-year-olds — notably the emergence of the omicron variant. Still, the lack of involvement of the FDA’s expert panel on that question was striking, and observers noticed. Helen Branswell, a senior writer for the health and science publication STAT News, tweeted that the FDA had “authorized Pfizer booster shots for 16- & 17-years olds, without asking its vax expert panel for advice.” She added, “This approach sidesteps what would likely have been lengthy discussion about myocarditis” — an uncommon side effect of the mRNA vaccines, which had drawn careful study in earlier steps of the approval process.

In a news release, the FDA explained that it didn’t convene the outside committee because approving boosters for 16- and 17-year-olds “does not raise questions that would benefit from additional discussion by committee members.” But that is unpersuasive, given the previously expressed views of panel members. The CDC has not explained why it did not convene its own panel of vaccine experts for its recent decision.

The FDA and the CDC need their experts. This is a particularly challenging time in the pandemic, as scientists try to understand how omicron changes the picture. Some people, including us, predict that the original two-shot vaccination regimen for the existing mRNA vaccines will continue to offer substantial protection against serious disease in people who aren’t at high risk, even with the new variant’s emergence. There are significant questions about how effective boosting with a non-omicron-specific vaccine will be or how long any effect will last. Others argue that boosters for all are absolutely essential. Still others are saying that not only is a third shot needed but probably a fourth one as well.

Emergency situations call for rapid high-stakes decision-making with limited data. Exigency might be offered as an excuse for bypassing the advisory process, but that’s the exact circumstance when expert discussion and interpretation of the data can make the biggest difference. Both the CDC and the FDA are able to convene their advisory committees on short notice, so there is no need to go without the benefit of these meetings. If for some reason these processes are bypassed, it is critical that the reasons are made clear and public.

Many people were appropriately outraged when the FDA, under the Trump administration, made important decisions, including authorizations of hydroxychloroquine and convalescent plasma for covid-19, under what appeared to be extreme political pressure and without advisory committee input. We should apply the same standards to the Biden administration.

As a country, we are weaker when we bypass our scientific experts. Although some may find it convenient to make policy without their input, the long-term consequences will hurt public health.


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