- On Monday, Pfizer announced that late-stage trials for its coronavirus vaccine have, so far, been more than 90% effective.
- The company, along with its partner BioNTech, are expected to apply for an emergency authorization from the Food and Drug Administration later this month.
- Still, more data from Pfizer’s ongoing third-phase trials must be collected, and these results must ultimately be peer-reviewed by other experts in the field before the vaccine is proven to be both safe and effective.
- Following the news, Vice President Mike Pence cited the Trump administration’s Operation Warp Speed as a key factor in Pfizer’s success, but as Pfizer stated, it has refused to accept government funding for vaccine research and development.
Pfizer Says Vaccine 90% Effective
Pfizer and the German biotechnology firm BioNTech said on Monday that their joint coronavirus vaccine is more than 90% effective.
Notably, this is the strongest indication yet that a safe and effective coronavirus vaccine could soon be made available for millions of people. It’s also setting a record pace. Vaccines typically take years to develop.
“I would say it’s a historical moment,” Kathrin Jansen, the head of vaccine research and development at Pfizer, told The New York Times. “Something like this has never happened before.”
“The results are really quite good, I mean extraordinary,” said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, according to The Washington Post.
The trial, which is currently in phase 3, involves over 43,500 people. Of those people, half were given two doses of the vaccine trial and half were given a placebo.
In total, 94 of the people in the study have contracted COVID-19 (defined by Pfizer’s researchers as testing positive and displaying symptoms). Notably, Pfizer’s 90% efficacy figure comes from determining whether each of these 94 people was given the actual vaccine or a placebo. For the vaccine candidate to be 90% effective, that would mean at least 85 of those people must have come from the placebo group.
To note, the goal of vaccines are to prevent people from catching a virus, such as COVID-19 — not to treat people who’ve already been infected.
Pfizer to Apply for Emergency Authorization
Even though Pfizer’s announcement is a very hopeful sign, this data still needs to be peer-reviewed by other experts in the field.
Among the crucial questions that must be answered, scientists will need to determine how long this vaccine candidate offers protection and how it performs on high-risk groups, such as those with weakened immune systems. They will also need to evaluate whether the 94 cases documented by Pfizer were mostly mild or severe, as well as how cases differed between those who received the vaccine and those who received the placebo.
The trial itself also isn’t over. Pfizer and BioNTech will continue to collect data until 164 people in the trial contract COVID-19 — 70 more people. That could take a few weeks. Notably, it could also mean that the 90% efficacy finding could change.
Nonetheless, Pfizer and BioNTech plan to submit an emergency authorization application to the Food and Drug Administration after the third week of this month, possibly sometime during the week of Thanksgiving.
The companies are waiting until then because they say that’s around the time they expect to have two full months of safety follow-up data, as well as data on their manufacturing process.
Even though they’re officially waiting, Pfizer and BioNTech have already ramped up the production of their vaccine. According to The Washington Post, they hope to manufacture 50 million doses by the end of the year. Since the vaccine comes in two doses, that’d be enough for 25 million people. Beyond that, Pfizer and BioNTech have a goal of 1.3 billion doses by the end of 2021.
If Pfizer’s data does turn out to be as good as it suggests, that may bode well for another company conducting late-stage trials: Moderna. Moderna’s vaccine is very similar to Pfizer’s, as both use RNA to generate immunity against the coronavirus.
Pfizer Did Not Receive Government Support
Like many medical experts, politicians have been optimistic about these results. President-Elect Joe Biden, for example, congratulated “the brilliant men and women who helped produce this breakthrough and to give us such cause for hope.”
In his statement, Biden also stressed the need to continue wearing masks, noting that Americans have died from COVID-19 at a rate of 1,000 people per day over the past week.
Meanwhile, President Trump celebrated the vaccine’s reported efficacy rate and the bump in the stock market that this news brought. To note, in addition to investors’ reaction to Pfizer, the stock market also saw initial gains Monday because Biden has now been projected to win the presidency.
In another tweet, Vice President Mike Pence celebrated Pfizer’s 90% efficacy projection; however, Pence also seemed to suggest that Pfizer and BioNTech’s success was because of a partnership with the U.S. government.
In reality, unlike other vaccine developers that are also in late-stage trials, Pfizer never accepted any money from the government for vaccine research or development.
The “public-private partnership” Pence is referring to in his tweet is known as Operation Ward Speed, the Trump administration’s initiative aimed at developing a coronavirus vaccine.
“We were never part of the Warp Speed,” Jansen told The New York Times. “We have never taken any money from the U.S. government, or from anyone.”
In fact, the very reason Pfizer chose not to engage in Warp Speed was to remain independent and devoid of political influence.
“We have always said that science is driving how we conduct ourselves — no politics,” Jansen told The Times.
To note, in July, the U.S. government did reach a deal to buy 100 million doses from Pfizer for nearly $2 billion. That contract also included an option for the government to buy 500 million more doses. Nonetheless, that is much different than trying to claim that Operation Warp Speed is the reason why Pfizer has a seemingly effective vaccine.
See what others are saying: (The Washington Post) (The New York Times) (INSIDER)
Amazon Backs GOP Bill to Legalize Marijuana in Effort to Ramp Up Lobbying
The proposal is the first Republican-sponsored marijuana bill Amazon has backed since the company first began lobbying for legalization last summer.
Amazon Endorses States Reform Act
Amazon announced Tuesday that it is endorsing a Republican-backed proposal to legalize marijuana.
The move comes as the e-commerce giant has ramped up its efforts to legalize cannabis on the federal level since it came out in support of the idea last summer. Amazon argues that the move would remove hiring barriers — which disproportionately impact people of color — and, in turn, could increase the company’s application pool and boost employee retention.
The company has previously backed similar proposals by forward by Democrats, but Tuesday’s announcement marks the first time Amazon has put its support behind a Republican-sponsored bill aimed at addressing the issue.
The legislation, called the States Reform Act, was authored by Rep. Nancy Mace (R-S.C.). Among other measures, it would remove cannabis as a Schedule I substance, allow states to create their own laws, impose an excise tax, and regulate the drug in a similar fashion to alcohol.
While Mace’s bill is fundamentally very similar to others put forth by Democrats, by proposing it herself, the Republican hopes to rally other members of her party around the idea that legalization is pro-business, pro-state’s rights, and anti-big government.
The measure has already received support from the highly influential conservative group, American’s for Prosperity, which is funded by the Koch brothers.
Mace and Amazon have painted the company’s endorsement as a game-changer for garnering more support — both from other large corporations and politicians on either side of the aisle. Mace specifically told reporters she believes Amazon’s decision will push other companies to do the same. If more major corporations like Amazon back the effort, other Republicans may be more persuaded to jump on board.
That sentiment was echoed by Brian Huseman, Amazon’s vice president of public policy, who said in an interview with The Washington Post that the company was “particularly excited by Congresswoman Mace’s bill” because “it shows that there’s bipartisan support for this issue.”
Huseman also emphasized that, as part of its decision to back her bill, Amazon will use its powerful influence in Washington to try and drum up bipartisan support.
“We are talking with members of both parties, including Republicans, about why we think this is the right thing to do, especially from the standpoint of a major employer and what this means for our business and our employees and broadening the employee base,” he continued.
See what others are saying: (The Washington Post) (Forbes) (Marijuana Moment)
CDC Data Shows Booster Shots Provide Effective Protection Against Omicron
Public health experts have encouraged Americans to get boosted to protect themselves against the omicron variant, but less than 40% of fully vaccinated people who are eligible for their third shot have received it.
A First Glimpse of Official Data on Boosters and Omicron
COVID-19 booster shots are effective at preventing Americans from contracting omicron and protecting those who do become infected from severe illness, according to three reports from the Centers for Disease Control and Prevention (CDC) published Friday.
The reports mark the first real-world data regarding the highly infectious variant and how it has impacted the U.S.
One of the CDC reports, which studied data from 25 state and local health departments, found that there were 149 cases per 100,000 people among those had been boosted on average each week.
In comparison, the figure was 255 cases per 100,000 people in Americans who had only received two shots.
Another study that looked at nearly 88,000 hospitalizations in 10 states found that the third doses were 90% effective at preventing hospitalization.
By contrast, those who received just two shots were only 57% protected against hospitalization by the time they were eligible for a booster six months after their second dose.
Additionally, the same report also found that the boosters were 82% effective at preventing visits to emergency rooms and urgent care centers, a marked increase from the 38% efficacy for those who were six months out from their two-shot regime and had not yet received a third.
Low Booster Shot Vaccination Rates
Public health officials hope that the new data will urge more Americans to get their booster shots.
Since the emergence of omicron, experts and leading political figures have renewed their efforts to encourage people to get their third shots, arguing they are the best form of protection.
The CDC currently recommends that everyone 12 and older get a booster shot five months after their second shot of Pfizer and Moderna or two months after receiving the single-dose Johnson & Johnson vaccine. Still, in the U.S., less than 40% of fully vaccinated individuals eligible for a third shot have gotten one.
While COVID cases in the country have begun to drop over the past several days from their peak of over 800,000 average daily infections, the figures are still nearly triple those seen in the largest previous surges.
Hospitalizations have also slowly begun to level out over the last week in places that were hit first, such as New York City and Boston, but medical resources still remain strained in many parts of the country that experienced later surges and have not yet seen cases slow.
Some experts predict that the U.S. will see a sharp decline in omicron cases, as experienced in South Africa and Britain. Still, they urge American’s to get boosted to ensure their continued protection from the variant, as well as other strains that will emerge.
See what others are saying: (The Washington Post) (CNN) (The New York Times)
California Bill Would Allow Kids 12 and Up to Get Vaccinated Without Parental Consent
Nearly one million California teens and preteens between the ages of 12 and 17 are not vaccinated against COVID-19.
State Senator Proposes Legislation
Legislation proposed in California on Thursday would allow children age 12 and up to get vaccinated without parental consent.
State Sen. Scott Wiener (D-San Francisco) introduced Bill 866 in the hope it could boost vaccination rates among teenagers. According to Wiener, nearly one million kids aged 12- to 17-years old remain unvaccinated against COVID-19 in the state of California.
“Unvaccinated teens are at risk, put others at risk & make schools less safe,” Wiener tweeted. “They often can’t work, participate in sports, or go to friends’ homes.”
“Many want to get vaccinated but parents won’t let them or aren’t making the time to take them. Teens shouldn’t have to rely on parents’ views & availability to protect themselves from a deadly virus.”
Currently, teens in California can receive vaccines for human papillomavirus and hepatitis B without parental consent. They can also make other reproductive or mental healthcare choices without a guardian signing off. Wiener argues that their medical autonomy should expand to all vaccines, especially during a pandemic that has already killed roughly 78,000 Californians.
Vaccine Consent Across the U.S.
“Teens shouldn’t have to plot, scheme or fight with their parents to get a vaccine,” he said. “They should simply be able to walk in & get vaccinated like anyone else.”
Bill 866 would allow any kids ages 12 and up to receive any vaccine approved or granted emergency use authorization by the Food and Drug Administration and recommended by the Centers for Disease Control and Prevention. Currently, Pfizer’s COVID vaccine has been fully approved by the FDA for those 16 and older. It has received emergency authorization for ages five through 15.
Across the United States, vaccine consent ages vary. While the vast majority of states require parental approval for minors to be vaccinated against COVID-19, kids as young as 11 can get the jab on their own in Washington, D.C. In Alabama, kids can receive it without parental consent at 14, in Oregon at 15, and in Rhode Island and South Carolina at 16. According to the Kaiser Family Foundation, providers can waive consent in certain cases in Arkansas, Idaho, Washington, and Tennesee.
In October, California became the first state to announce plans to require that students receive the COVID-19 vaccine to attend class. The mandate has yet to take effect, but under the guidelines, students will be “required to be vaccinated for in person learning starting the term following FDA full approval of the vaccine for their grade span.”
In other words, once the FDA gives a vaccine full approval for those aged 12 and up, it will be required the following session for kids in grades 7-12. Once it does so for kids as young as five, the same process will happen for children in kindergarten through sixth grade. There will also be room for exemptions from the mandate.
The Fight to Vaccinate California
This week, a group of California state legislators formed a Vaccine Work Group in order to boost public health policies in the state. Wiener is among the several members who are “examining data, hearing from experts, and engaging stakeholders to determine the best approaches to promote vaccines that have been proven to reduce serious illness, hospitalization and death from COVID-19.”
“Vaccines protect not only individuals but also whole communities when almost everyone is vaccinated at schools, workplaces and businesses, and safe and effective COVID-19 vaccines have already prevented the deaths of hundreds of thousands of Americans,” Sen. Dr. Richard Pan (D-Sacramento) said in a press release. “Public safety is a paramount duty of government, and I am proud to join a talented group of legislators in the pro-science Vaccine Work Group who want to end this disastrous pandemic and protect Californians from death and disability by preventable diseases.”
While vaccine policies have been a divisive subject nationwide, including in California, state politicians and leaders are hopeful public health initiatives will prevail.
“If we allow disinformation to drive our state policy making we will not only see more Americans needlessly suffer and die, but we will sacrifice the long term stability of our society having effectively abandoned the idea that we all must work together to protect each other in times of crisis.” Catherine Flores Martin, the Executive Director of the California Immunization Coalition, added.