- In a document obtained Wednesday by The New York Times, CDC Director Robert Redfield instructed state and local health officials to be ready to distribute COVID-19 vaccines as soon as Nov. 1, two days before the 2020 Elections.
- The following day, Health and Human Services Secretary Alex Azar said the projected goal has “nothing to do with elections,” but concerns from health experts have persisted because President Donald Trump has repeatedly pushed for a vaccine ahead of the elections.
- Health officials have also expressed hesitation that adequate data will be available by next month, with Dr. Anthony Fauci saying that a vaccine by that time is “conceivable” but unlikely.
CDC Pushes Nov. 1 Vaccine Release
Robert Redfield, director of the Centers for Disease Control and Prevention, has instructed state and local health officials to prepare to distribute a COVID-19 vaccine as early as Nov. 1.
The information was obtained by The New York Times Wednesday from a CDC document. In that document, which is dated Aug. 27, Redfield told health officials to prepare to distribute up to 3 million doses of vaccines by the end of next month, 20 to 30 million by the end of November, and 35 to 45 million by the end of the year.
In a separate document also released Wednesday, Redfield urged states to begin developing plans for how to proceed with early vaccinations. That includes determining which groups should be prioritized for the vaccine. Health-care workers and other at-risk groups would likely be up first.
Redfield said that the CDC “if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020.”
Are the CDC and FDA Rushing a Vaccine for Election Day?
The November 1 goal, just two days before Election Day, has raised questions and concerns from experts, as many are worried that such a date might not be feasible.
Thursday morning, Health and Human Services Secretary Alex Azar denied that the CDC’s goal date is politically motivated.
“It has nothing to do with elections,” Azar told CBS News. “This has to do with delivering safe, effective vaccines to the American people as quickly as possible and saving people’s lives. Whether it’s Oct. 15, whether it’s Nov. 1, whether it’s Nov 15, it’s all about saving lives but meeting the FDA standards of safety and efficacy.”
Criticism and concern that that President Donald Trump is pressuring agencies like the CDC and the Food and Drug Administration to rush a vaccine by cutting corners is nothing new.
Both Trump’s admiration for hydroxychloroquine and plasma recovered from COVID-19 patients have been called into question, as neither have been proven to be safe and effective. Trump has also openly said that a vaccine could be ready as early as Election Day.
On Sunday, FDA Commissioner Stephen Hahn told the Financial Times that the FDA could authorize a vaccine before clinical trials are completed.
“It is up to the sponsor to apply for authorization or approval, and we make an adjudication of their application,” Hahn said. “If they do that before the end of Phase 3, we may find that appropriate. We may find that inappropriate. We will make the decision.”
While Hahn indicated that benefits would still need to outweigh risks for that to happen, his willingness to do so — coupled with the previous concerns — led many to question whether he is potentially skirting the scientific process because of the president.
Still, Hahn has denied that his statement means the FDA will submit to Trump’s pressure.
Why There Is Concern About Vaccines Being Rushed
Hydroxychloroquine and plasma are therapeutics. While evidence of their safety and effectiveness is still important, therapeutics are generally given to people who are already sick and might not have any other options.
Vaccines, on the other hand, are given to people who are healthy to keep them from getting sick, so scientists need to have a much higher standard of proof that they’re safe.
There are currently three in the U.S. that have entered Phase 3 trials: the Pfizer, Moderna, and AstraZeneca vaccines. Of those, Moderna is still in the process of recruiting subjects, and it’s unknown when it could start showing results.
AstraZeneca began its Phase 3 trial Monday, with the full experiment expected to last eight weeks because its vaccine must be given in two doses, each given a month apart. The company has stated that it does not expect preliminary results until around Thanksgiving.
Thus, as many experts noted to the Associated Press, they do not understand how adequate data will be available by Nov. 1 to prove that these two vaccines are safe and effective.
“Being ready is reasonable. Cutting short phase 3 trials before you get the information you need isn’t,” Dr. Paul Offit, an immunization expert who sits on the FDA’s vaccine advisory committee, told the outlet.
Is a Vaccine by Nov. 1 Possible?
It is possible that some preliminary results might be available as soon as next month. For example, Pfizer has said that it’s on track to seek government review in October.
On Tuesday, Dr. Anthony Fauci, the nation’s leading infectious disease expert, told Kaiser Health News that clinical trials could be stopped early if they provide overwhelmingly positive results that show a vaccine is safe and effective.
Fauci said scientists would have a “moral obligation” to make the vaccine available to all participants in the study if that were the case, thus speeding up that vaccine’s ability to hit the public.
“If there are a certain amount of infections within a particular trial, it’s conceivable that you could have [a vaccine] by October, but I don’t think that’s likely,” Fauci told CNN on Thursday.
See what others are saying: (NBC News) (Politico) (Associated Press)
Republican Congressman Proposes Bill to Ban Anyone Under 16 From Social Media
The proposal comes amid a growing push for social media companies to be stringently regulated for child and adolescent use.
The Social Media Child Protection Act
Rep. Chris Stewart (R-Ut.) introduced legislation Thursday that would ban all Americans under the age of 16 from accessing social media.
The proposal, dubbed the Social Media Child Protection Act, would require social media companies to verify users’ ages and give parents and states the ability to bring legal actions against those platforms if they fail, according to a press release.
The legislation would also mandate that social media platforms implement “reasonable procedures to protect the confidentiality, security, and integrity of personal information collected from users and perspective users.”
The Federal Trade Commission (FTC) would be given the authority to enforce these regulations and implement fines for violations.
Stewart has argued that the move is necessary to protect children from the negative mental health impacts of social media.
“There has never been a generation this depressed, anxious, and suicidal – it’s our responsibility to protect them from the root cause: social media,” he said in a statement announcing the bill.
“We have countless protections for our children in the physical world – we require car seats and seat belts; we have fences around pools; we have a minimum drinking age of 21; and we have a minimum driving age of 16,” the Congressman continued.
“The damage to Generation Z from social media is undeniable – so why are there no protections in the digital world?”
While Stewart’s arguments are nothing new in the ongoing battle around children and regulating social media, his legislation has been described as one of the most severe proposals on this front.
The plan would represent a huge shift in verification systems that critics have long said fall short. Many social media sites like TikTok and Twitter technically ban users under 13 from joining, but there is no formal verification process or mechanisms for enforcement. Companies often just ask users to provide their birthdays, so those under 13 could easily just lie.
Backlash and Support
Stewart — who spent the weeks before the rollout of his bill discussing the matter with the media — has already gotten pushback from many who say the idea is too extreme and a bad approach.
Carl Szabo, the vice president and general counsel of the social media trade group NetChoice, told The Washington Post that such a decision should be left to parents.
“Rather than doomsaying or trying to get between parents and their families, the government should provide tools and education on how best to use this new technology, not demonize it,” he said.
Others have also argued that the move could cut off access to powerful and positive online resources for kids.
“For many kids, especially LGBTQ young people who may have unsupportive parents or live in a conservative area, the internet and social media are a lifeline,” Evan Greer, the director of the advocacy group Fight for the Future, told The Post. “We need better solutions than just cutting kids off from online community and educational resources.”
Lawmakers have also echoed that point, including Rep. Ro Khanna (D-Ca.), who represents Silicon Valley. However, there also seems to be support for this measure. At least one Democratic Congressmember has told reporters they are open to the idea, and Stewart says he thinks the proposal will have broad bipartisan backing.
“This is bipartisan… There’s Democratic leaders who are actually maneuvering to be the lead co-sponsor on this,” he told KSL News Radio, adding that President Joe Biden recently wrote an op-ed for The Wall Street Journal that referenced similar ideas.
A Growing Movement
Stewart is just one among the growing number of lawmakers and federal officials who have voiced support for keeping kids and younger teens off social media altogether.
In an interview with CNN Sunday, U.S. Surgeon General Vivek Murthy expressed concern regarding “the right age for a child to start using social media.”
“I worry that right now, if you look at the guidelines from the platforms, that age 13 is when kids are technically allowed to use social media,” he said. “But there are two concerns I have about that. One is: I, personally, based on the data I’ve seen, believe that 13 is too early.”
Murthy went on to say that adolescents at that age are developing their identity and sense of self, arguing that social media can be a “skewed and often distorted environment,” adding that he is also worried about the fact that the rules around age are “inconsistently implemented.”
His comments gained widespread backing. At least one Senator posted a tweet agreeing, and an FTC Commissioner also shared the remarks on the platform. Stewart, for his part, explicitly cited Murthy’s remarks in the press release announcing his bill.
See what others are saying: (The Washington Post) (KSL News Radio) (CNN)
Feds Investigate Classified Files Found in Biden’s Former Office
The documents reportedly include U.S. intelligence memos and briefing materials that covered topics such as Ukraine, Iran, and the United Kingdom
What Was in the Files?
President Biden’s legal team discovered about 10 classified files in his former office at the Penn Biden Center for Diplomacy and Global Engagement in Washington D.C., the White House revealed Monday.
The Department of Justice has concluded an initial inquiry into the matter and will determine whether to open a criminal investigation.
According to a source familiar with the matter who spoke to CNN, they include U.S. intelligence memos and briefing materials that covered topics such as Ukraine, Iran, and the United Kingdom.
A source also told CBS News the batch did not contain nuclear secrets and had been contained in a folder in a box with other unclassified papers.
The documents are reportedly from Biden’s time as vice president, but it remains unclear what level of classification they are and how they ended up in his office.
Biden kept an office in the. Penn Biden Center, a think tank about a mile from the White House, between 2017 and 2020, when he was elected president.
On Nov. 2, his lawyers claim, they discovered the documents as they were clearing out the space to vacate it.
They immediately notified the National Archives, which retrieved the files the next morning, according to the White House.
What Happens Next?
Attorney General Merrick Garland must decide whether to open a criminal investigation into Biden’s alleged mishandling of the documents. To that end, he appointed John Lausch Jr., the U.S. attorney in Chicago and a Trump appointee, to conduct an initial inquiry.
Garland reportedly picked him for the role despite him being in a different jurisdiction to avoid appearing partial.
Lausch has reportedly finished the initial part of his inquiry and provided a preliminary report to Garland.
If a criminal investigation is opened, Garland will likely appoint an independent special counsel to lead it.
The case mirrors a similar DoJ special counsel investigation into former President Donald Trump’s alleged mishandling of classified materials and obstruction of efforts to properly retrieve them.
On Nov. 18, Garland appointed Jack Smith to investigate over 300 classified documents found at Trump’s Florida residence, Mar-a-Lago.
Trump resisted multiple National Archives requests for the documents for months leading up to the FBI’s raid on his property, then handed over 15 boxes of files only for even more to be found still at Mar-a-Lago.
“When is the FBI going to raid the many houses of Joe Biden, perhaps even the White House?” Trump wrote on Truth Social Monday. “These documents were definitely not declassified.”
Rep. James Comer (R-KY), the new chairman of the House Oversight Committee, told reporters he will investigate the Biden files.
Republicans have been quick to pounce on the news and compare it to Trump’s classified files, but Democrats have pointed out differences in the small number of documents and Biden’s willingness to cooperate with the National Archives.
The White House has yet to explain why, if the files were first discovered six days before the midterm elections, the White House waited two months to reveal the news to the public.
See what others are saying: (CNN) (The New York Times) (BBC)
Lawmakers Propose Bill to Protect Fertility Treatments Amid Post-Roe Threats
The move comes as a number of states are considering anti-abortion bills that could threaten or ban fertility treatments by redefining embryos or fetuses as “unborn human beings” without exceptions for IVF.
The Right To Build Families Act of 2022
A group of Democratic lawmakers introduced a bill Thursday that would codify the right to use assisted reproductive technologies like in-vitro fertility (IVF) treatments into federal law.
The legislation, dubbed the Right To Build Families Act of 2022, was brought forward by Sens. Tammy Duckworth (D-Il) and Patty Murray (D-Wa.) alongside Rep. Susan Wild (D- Pa.). The measure would bar any limits on seeking or receiving IVF treatments and prohibit regulations on a person’s ability to retain their “reproductive genetic materials.”
The bill would also protect physicians who provide these reproductive services and allow the Justice Department to take civil action against any states that try to limit access to fertility treatments.
The lawmakers argue it is necessary to protect IVF because a number of states have been discussing and proposing legislation that could jeopardize or even ban access to the treatments in the wake of the Roe v. Wade reversal.
“IVF advocates in this country today are publicly telling us, ‘We need this kind of legislation to be able to protect this,’” Murray told HuffPost. “And here we are after the Dobbs decision where states are enacting laws and we have [anti-abortion] advocates who are now starting to talk, especially behind closed doors, about stopping the right for women and men to have IVF procedures done.”
Fertility Treatments Under Treat
The state-level efforts in question are being proposed by Republican lawmakers who wish to further limit abortions by redefining when life begins. Some of the proposals would define embryos or fetuses as “unborn human beings” without exceptions for those that are created through IVF, where an egg is fertilized by a sperm outside the body and then implanted in a uterus.
For example, a bill has already been pre-filed in Virginia for the 2023 legislative session that explicitly says life begins at fertilization and does not have any specific language that exempts embryos made through IVF.
Experts say these kinds of laws are concerning for a number of reasons. In the IVF process, it is typical to fertilize multiple eggs, but some are discarded. If a person becomes pregnant and does not want to keep the rest of their eggs. It is also normal that not all fertilized eggs will be viable, so physicians will get rid of those.
Sometimes doctors will also implant multiple fertilized eggs to increase the likelihood of pregnancy, but that can result in multiple eggs being fertilized. In order to prevent having multiple babies at once and improve the chance of a healthy pregnancy, people can get a fetal reduction and lower the number of fetuses.
All of those actions could become illegal under proposals that do not provide exemptions.
“In my case, I had five fertilized eggs, and we discarded three because they were not viable. That is now potentially manslaughter in some of these states,” said Duckworth, who had both of her daughters using IVF.
“I also have a fertilized egg that’s frozen. My husband and I haven’t decided what we will do with it, but the head of the Texas Right to Life organization that wrote the bounty law for Texas has come out and specifically said he’s going after IVF next, and he wants control of the embryos,” Duckworth added.
In a hearing after Roe was overturned, Murray also raised concerns about “whether parents and providers could be punished if an embryo doesn’t survive being thawed for implantation, or for disposing unused embryos.”
Experts have said that even if anti-abortion laws defining when life begins do provide exceptions, it would be contradictory and confusing, so providers would likely err on the side of caution and not provide services out of fear of prosecution.
“[Abortion bans] are forcing women to stay pregnant against their will and are, at the very same time, threatening Americans’ ability to build a family through services like IVF,” Murray said in a statement to Axios. “It’s hard to comprehend, and it’s just plain wrong.”
The federal legislation to combat these efforts faces an uphill battle. It is unlikely it will be passed in the last few days of lame duck session, and with control of Congress being handed to Republicans come January, movement in the lower chamber will be hard fought.
Duckworth, however, told Axios that she will keep introducing the legislation “until we can get it passed.”