- Dr. Anthony Fauci reaffirmed the safety of AstraZeneca’s COVID-19 vaccine on Wednesday after U.S. health officials accused the company of providing “outdated and potentially misleading” data to make the shot appear more effective.
- On Monday, AstraZeneca said clinical trials found its vaccine to be 79% effective, but the group of independent experts overseeing the trial said that data did not include an additional month of testing that actually placed the efficacy rate at between 69% to 75%.
- The drugmaker issued another statement Tuesday claiming the 79% rate came from a partial report that was consistent with the full analysis and promised to publish that information within 48 hours.
- While Fauci criticized AstraZeneca for publishing a statement that “wasn’t completely accurate” and could contribute to vaccine hesitancy, he argued the data was still sound and the shot will prove very effective.
AstraZeneca Accused of Misrepresenting Data
Dr. Anthony Fauci, the nation’s leading expert on infectious diseases, continued his efforts to dispel vaccine hesitancy and restore confidence in the AstraZeneca COVID-19 shot on Wednesday after U.S. health officials cast doubt on its most recent clinical trials.
In a press release Monday, AstraZeneca announced that the large U.S. clinical for its COVID vaccine found the shots to be 79% effective. However, just hours later, a group of medical experts overseeing the trial wrote a letter essentially accusing the company of cherry-picking its data.
According to outlets that saw the letter, the experts said they were concerned that the drugmaker had provided “outdated and potentially misleading” data on its inoculation to make it seem more effective than the full data showed.
Reportedly, the independent monitors pushed back on AstraZeneca’s claim that the jab was 79% effective because that figure did not include an additional month of testing, which, when taken into account, made the effectiveness range from 69% to 75%.
AstraZeneca responded in another statement Tuesday, claiming that the numbers published the day prior were indeed based on “an interim analysis with a data cut-off” of Feb. 17. That data, the company claimed, was still consistent with the full analysis of their vaccine trials. They promised to release the complete trial within 48 hours.
Public health experts reiterated their apprehension, with many also expressing concern that the situation will cause more scrutiny from regulators and erode public trust in the inoculation at a time when there is already doubt.
Last week, a European regulator reaffirmed the vaccine’s safety after over a dozen countries paused their rollout of the shot citing concerns it caused blood clots. The U.S. clinical trial, which is the largest trial to date, did not turn up any signs of this problem.
Experts Work to Instill Public Confidence
While speaking on Good Morning America Tuesday, Dr. Fauci criticized the drugmaker for issuing a press release that “wasn’t completely accurate,” but emphasized the solidity of the data and the need for experts to reify public trust in the jab.
“This is really what you call an unforced error because the fact is this is very likely a very good vaccine,” he said. “This kind of thing does really cast some doubt about the vaccines and maybe contribute to the hesitancy. It was not necessary.”
“If you look at it, the data really are quite good,” he added. “We have to keep essentially trying as hard as we can to get people to understand there are safeguards in place.”
As Dr. Fauci and other public health officials have also noted, the 69% to 75% efficacy rate widely believed to represent the actual effectiveness of the AstraZeneca vaccine is still quite good and similar to others on the market, like the one-shot Johnson & Johnson product.
Some experts have also said the AstraZeneca jab is arguably the world’s most important vaccine right now. The low cost and relatively easy storage compared to other COVID inoculations have made the AstraZeneca version especially accessible and thus absolutely critical in the global fight against the coronavirus. Currently, the COVID-19 shot is the most widely used globally, having been authorized in more than 70 countries.
While it has not yet been approved in the U.S., during a press conference Wednesday, Dr. Fauci assured Americans that the Food and Drug Administration’s review of the jab will be transparent.
“Hopefully, that will dispel any hesitancy associated with this little bump in the road we happened to have most recently with AstraZeneca,” he said.
“At the end of the day,” he added, the data shows that the AstraZeneca shot, “is going to turn out to be a good vaccine.”
See what others are saying: (The New York Times) (The Washington Post) (Business Insider)
U.S. Pledges To Donate 500 Million More Vaccines Globally
The announcement comes as wealthy nations face pressure to help lower-income countries deal with the pandemic and as American vaccine makers face calls to share their technology.
Biden Promises More Vaccines
President Joe Biden announced Wednesday that the U.S. will purchase 500 million doses of Pfizer’s COVID-19 vaccine for countries in need, bringing the total number of U.S. vaccine donations to more than 1.1 billion.
Biden’s pledge, which was made at a virtual COVID-19 summit, comes as world leaders and organizations have criticized wealthy nations for not doing enough to help lower-income countries deal with the pandemic. Many have also slammed countries like the U.S. for moving forward with plans for booster shots while so much of the world remains unvaccinated.
According to the University of Oxford’s Our World in Data project, of the six billion shots administered globally, nearly 80% percent have been given in high- and upper-middle-income countries compared to just 0.5% in low-income countries.
While several wealthy nations begin to give booster shots, just 2% of people in low-income countries have received at least one dose.
Pressure Grows for American Companies to Share Vaccine Technology
It’s not just wealthy countries and their leaders that are being met with criticism over the massive vaccination gap. There is also a lot of growing pressure on American drug companies to share their formulas with manufacturers in poor nations that need more doses.
Senior officials told The New York Times that the Biden administration privately asked Pfizer and Moderna to engage in joint ventures where they license their technology to contract manufacturers in an effort to provide vaccines to low- and middle-income nations.
While those conversations reportedly prompted Pfizer to sell the U.S. the 500 million doses announced this Wednesday at a not-for-profit price, the company still refused to license its technology.
Meanwhile, the alleged discussions appear to have had no impact at all on Moderna.
Many have argued the Moderna has even more of an obligation to share its technology given that it was developed in part by the National Institutes of Health. On top of that, the company accepted an additional $2.5 billion in taxpayer money as part of Operation Warp Speed.
In a statement to The Times on Tuesday, a Moderna spokeswoman said that the company had agreed not to enforce its COVID-related patents and was “willing to license our intellectual property for Covid-19 vaccines to others for the post pandemic period.”
But experts say that vaccine technology is needed now, not when the pandemic is over.
Many have argued that Biden should put more pressure on the companies to share their intellectual property, including some legal experts who said he could compel them to do so using the Defense Production Act, which gives the president broad emergency powers.
Administration officials, however, have argued that forcing the companies to share the information is more complicated, and any efforts to do so would result in legal battles that will ultimately be counterproductive.
See what others are saying: (The New York Times) (NPR) (The Wall Street Journal)
Texas Doctor Says He Violated Abortion Law, Opening Matter Up for Litigation
Under the state’s new law, any citizen could sue the doctor, which would make the matter the first known test case of the restrictive policy.
Dr. Braid’s Op-Ed
A Texas doctor revealed in an op-ed published in The Washington Post Saturday that he performed an abortion in violation of the state’s law that bans the procedure after six weeks, before most people know they are pregnant.
The law, which is the most restrictive in the country and does not have exceptions for rape and incest, also allows civilians to sue anyone who helps someone receive an abortion after six weeks.
In the op-ed, Dr. Alan Braid, who has been practicing as an OB/GYN in Texas for 45 years, said that just days after the law took effect, he gave an abortion to a woman who was still in her first trimester but already beyond the state’s new limit.
“I acted because I had a duty of care to this patient, as I do for all patients, and because she has a fundamental right to receive this care,” he wrote. “I fully understood that there could be legal consequences — but I wanted to make sure that Texas didn’t get away with its bid to prevent this blatantly unconstitutional law from being tested.”
Braid went on to say that he understands he is taking a personal risk but that he believes it is worth it.
“I have daughters, granddaughters and nieces,” he concluded. “I believe abortion is an essential part of health care. I have spent the past 50 years treating and helping patients. I can’t just sit back and watch us return to 1972.”
If someone does opt to sue Braid over this matter, he could potentially be the state’s first test case in playing out the legal process. However, it is unclear if anti-abortion groups will follow through, despite their threats to enforce the law.
A spokesperson for Texas Right to Life, which set up a website to report people suspected of violating the ban, told reporters this weekend that it is looking into Braid’s claims but added, “It definitely seems like a legal stunt and we are looking into whether it is more than that.”
Even if abortion opponents hold off on Braid’s case, there are other legal challenges to the Texas law.
Shortly after the policy took effect, the Department of Justice filed a lawsuit attempting to stop it. Last week, the department filed an emergency motion asking a federal judge in the state to temporarily block the ban while that legal battle plays out, with a hearing for that motion set for Oct. 1.
Regardless of what side the federal judge rules for, the other is all but ensured to sue, and that fight could take the question to the Supreme Court in a matter of months.
See what others are saying: (NPR) (The Texas Tribune) (The Wall Street Journal)
Pfizer Says Low Dose of COVID-19 Vaccine Is Safe and Effective in Kids 5 to 11
Pfizer Says Kids’ Vaccine Works
Pfizer announced Monday morning that its joint COVID-19 vaccine with BioNTech is safe and effective in kids ages 5 to 11.
While Pfizer’s vaccine candidate for younger children is the same version the FDA has already approved for people 12 and older, the children’s dose is only one-third of the amount given to adults and teens. Still, Pfizer said the antibody response they’ve seen in kids has been comparable to the response seen in older participants.
Similarly, the company said side effects in children have been similar to those witnessed in adults.
Pfizer said it expects to finish submitting data, which still needs to be peer-reviewed and then published, to the FDA by the end of the month. From there, the agency will ensure that Pfizer’s findings are accurate and that the vaccine will be able to elicit a strong immune response in kids at its current one-third dosage.
That process could take weeks or even all of October, but it does open the possibility that the vaccine candidate could be approved around Halloween.
While experts like Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, have called Pfizer’s announcement largely predictable, they’ve also urged people to let the research run its course.
With cases among children skyrocketing in recent months, some parents have begun urging pediatricians to give their children the jab early. Those kinds of requests are likely to increase with Pfizer’s announcement; however, officials have warned parents about acting too quickly.
“No one should really be freelancing — they should wait for the appropriate approval and recommendations to decide how best to manage their own children’s circumstances,” Bill Gruber, Pfizer’s senior vice president of vaccine clinical research and development, said according to The Washington Post.