Pfizer vaccine's protection against Omicron drops as soon as three weeks after third dose: Study



The effectiveness of Pfizer and BioNTech's COVID-19 vaccine wanes rapidly against the Omicron variant, beginning to fade away as soon as three weeks after the second or third dose, a new study finds.

Researchers said that the antibody responses induced by a second and third dose of the vaccine were "transient" and that "additional booster doses may be necessary," although the vaccine still provides enough immunity to ward off hospitalization and death from COVID-19.

The Danish study, which was published in JAMA Network Open on Friday, examined 128 people who had received two or three doses of Pfizer/BioNTech's mRNA vaccine.

Scientists observed that the number of "neutralizing" antibodies induced by the vaccine that target the Omicron variant declined rapidly within weeks of taking the second and third shots. Antibodies attack the virus and stop it from replicating, which protects the body against infection and disease.

The study examined the antibody response in vaccinated patients to different strains of the coronavirus, including the original and Delta variant strains. Within four weeks of the second Pfizer/BioNTech dose, the concentration of Omicron-specific antibodies found in patients' blood was 14-fold lower than antibodies against the original virus strain.

Compared to the original and Delta variants, the proportion of Omicron-specific neutralizing antibodies fell "rapidly" from 76.2% four weeks after the second shot to 53.3% at weeks eight to 10, and then 19% at weeks 12 to 14, the researchers said.

After a third dose, Omicron-specific antibodies increased nearly 21-fold at week three and nearly 8-fold at week four, compared to antibody levels observed four weeks after the second dose.

However, antibody levels dropped between the third week and the eighth week after the third dose, with a 4.9-fold drop for the original strain, 5.6-fold for Delta, and 5.4 fold for Omicron observed.

This means that the number of antibodies the vaccine teaches the body to make to fight COVID-19 drops off as soon as four weeks after the second shot and three weeks after the third. Lower antibody levels offer less protection against the virus, which explains why people who have been fully vaccinated with two shots or have only had one booster may still get breakthrough Omicron infections.

The researchers say that additional booster shots may be needed to keep Omicron-specific antibody levels high and protect against disease, especially in older people.

Previous studies have shown that protection against infection offered by COVID-19 vaccines begins to wane after about six months. Older Americans, who are more vulnerable to severe disease, have been encouraged by public health officials to take vaccine booster shots to strengthen their antibody response to the virus.

According to U.S. Centers for Disease Control and Prevention data, about 69% of U.S. adults over age 65 have received a booster dose, while nearly 91% have completed their primary COVID-19 vaccination schedule.

The U.S. Food and Drug Administration in March authorized a second booster shot for Americans over the age of 50, citing evidence that suggested vaccine protection wanes over time and that older and immunocompromised people need additional protection offered by a fourth dose.

CDC considers adjusting COVID-19 vaccine schedules to lower risk of heart inflammation



The U.S. Centers for Disease Control and Prevention is considering changes to its COVID-19 vaccination schedule to reduce the risk of heart inflammation from mRNA vaccine shots.

During a meeting Friday, members of the CDC's Advisory Committee on Immunization Practices presented data that suggests there have been higher rates of myocarditis after receiving an mRNA COVID-19 vaccine, especially in young men. Advisory panel chairwoman Dr. Grace Lee said that a longer time period between vaccine doses could be safer and also improve the vaccine's effectiveness, according to the Washington Examiner.

“[The data is] ... fairly convincing that an extended interval is not only potentially safer from a myocarditis standpoint, but also potentially more effective,” Lee, a medical officer at the Lucile Packard Children’s Hospital at Stanford, said.

The advisory cited studies from Canada and England that suggested a longer period between vaccine doses reduced the risk of myocarditis and pericarditis, two kinds of heart inflammation that can be rare side effects of mRNA vaccination.

“The longer interval resulted in lower myocarditis rates, whereas the shorter interval had higher myocarditis and pericarditis rates,” Dr. Bryna Warshawsky of the Public Health Agency of Canada said.

Current CDC guidelines state that the two-dose Pfizer-BioNTech mRNA vaccine shots should be given three weeks apart, while the Moderna vaccine doses have a four-week period between shots.

The panel recommended that the guidelines be changed to allow for eight weeks between vaccine doses. The CDC has not yet decided whether to adopt the recommendations.

Increasing the time between primary vaccine doses would mean it will take longer for people who receive an mRNA vaccine shot to be considered "fully vaccinated" against COVID-19. It would also mean vaccinated individuals may have to wait longer to get a booster dose.

The CDC also on Friday released new recommendations for individuals with compromised immune systems.

The agency said that immunocompromised people who've completed the primary COVID-19 vaccine schedule and who have taken one booster shot should wait at least three months before receiving a second booster dose.

This is a reduction in time between booster doses from the previous recommendation, which was to wait at least five months after the third COVID-19 shot before getting a fourth shot.

The new guidelines apply to people age 18 and older who have taken the Moderna vaccine, as well as those 12 and older who have had the Pfizer shot.

Immunocompromised individuals who were vaccinated with the Johnson & Johnson vaccine are recommended to get an mRNA vaccine dose at least 28 days after the first shot, followed by a third booster dose at least two months later.

LIVE: CDC Advisors Meet on Moderna COVID-19 Vaccine www.youtube.com

FDA fully approves Moderna's COVID vaccine, pressures Pfizer to apply for emergency authorization of vaccine for kids younger than 5



The U.S. Food & Drug Administration on Monday granted its full approval to Moderna's COVID-19 vaccine for adults ages 18 and older. Additionally, the agency is reportedly pressuring Pfizer-BioNTech to apply for emergency use authorization for its vaccine to be given to children under 5.

Moderna's vaccine, called Spikevax, is the second mRNA vaccine to be fully approved for U.S. adults, following the full approval for Pfizer's vaccine, Comirnaty, in August. The FDA said that Spikevax had met the agency's "rigorous standards for safety, effectiveness and manufacturing quality required for approval."

“The FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19. The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” acting FDA Commissioner Janet Woodcock said.

The vaccine is a two-dose regimen, with doses delivered one month apart. Individuals who have received the primary doses can get a third booster dose five months after their second shot. The FDA has authorized the third Spikevax shot as a "mix and match" single booster dose for individuals age 18 and older who have completed primary vaccination with a different available COVID-19 vaccine, the FDA said.

“The approval was based on a comprehensive submission package including efficacy and safety data approximately six months after the second dose,” Moderna said after the FDA's announcement.

The approval was based on a comprehensive submission package including efficacy and safety data approximately six months after second dose.
— Moderna (@Moderna) 1643645269

Meanwhile, the Washington Post reported that Pfizer and its partner, BioNTech, will submit an application to the FDA as soon as Tuesday for emergency use authorization to give its vaccine to children ages 6 months to 5 years old.

FDA officials told the Post that the agency has "urged" the companies to apply for an EUA even though tests have shown that a two-dose regimen of Pfizer's vaccine for young children did not provide a strong enough immune response to protect from COVID-19.

In December, the companies announced they would begin testing three doses of their COVID-19 vaccine after preliminary research indicated that while the vaccine is safe, the immune response in 2- to -4-year-olds after two doses was weaker compared to the vaccines approved for adults. Pfizer and BioNTech said at the time they would apply for an EUA once the three-dose regimen was shown to be effective. But that data won't be ready until March.

The Biden administration appears impatient to have a vaccine approved for young children and is asking Pfizer and BioNTech to submit their EUA application before the data on the third dose is ready.

“We know that two doses isn’t enough, and we get that,” one of the officials that spoke to the Post said. "The idea is, let’s go ahead and start the review of two doses. If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don’t do anything until the third-dose data comes in.”

Another official reportedly said there is a consensus in the Biden administration on "seeing this move forward," referring to the EUA application.

The Washington Post's reporting matches what White House chief medical adviser Dr. Anthony Fauci said about pediatric COVID-19 vaccines last week.

Asked by reporters when the vaccine would be ready for children 2 to 4 years old, Fauci said that initial trials found the two-dose regimen of Pfizer-BioNTech's vaccine "did not yet reach the level of non-inferiority" in young children.

"It looks like it will be a three-dose regimen," Fauci said. "I don’t think we can predict when we will see an [emergency use authorization] with that, because the company is still putting the data before the FDA."

The Post reported that the FDA has faced pressure from some parents who want the agency to approve the vaccines for their children more quickly. Protect Their Future, a grassroots organization of physicians, parents, and advocates, has collected more than 5,700 signatures on a petition asking the FDA to approve a COVID-19 vaccine for younger children.

However, some doctors have cautioned that any actions taken by the federal government to rush approval of the COVID-19 vaccines could further undermine confidence in the safety and efficacy of the shots.

FDA asks federal judge for 55 years to complete FOIA request for Pfizer vaccine information



The Food and Drug Administration is asking a federal court to allow it to take nearly 55 years to release data on Pfizer's COVID-19 vaccine to the public.

The agency said in a court filing Monday that in order to complete a Freedom of Information Act request for data and information on the Pfizer-BioNTech vaccine, it will need to process 329,000 pages of documents and can only do so at a rate of 500 pages per month. At that rate, the information requested will not be fully released until the year 2076.

The FOIA request was submitted to the FDA in August by Public Health and Medical Professionals for Transparency, a group of more than 30 international public health professionals, medical professionals, scientists, and journalists that "exist solely to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines." The group includes academics and medical experts from Yale, Harvard Medical School, and UCLA; alumni from the Trump administration; and prominent health experts from around the world.

PHMPT is being represented by Siri & Glimstad, a New York-based law firm that has performed millions of dollars of legal work on behalf of groups opposed to vaccine mandates.

The medical transparency group had requested "all data and information for the Pfizer vaccine" including safety and effectiveness data; a protocol for a test or study; adverse reaction reports, product experience reports, consumer complaints, and other similar data and information; a list of all active ingredients and any inactive ingredients; an assay method or other analytical method; all correspondence and written summaries of oral discussions relating to the vaccine; all records showing Pfizer and BioNTech's testing of a particular lot; and all records showing the testing of and action on a particular lot by the FDA.

PHMPT also made a request for expedited processing of its FOIA submission, arguing there is a "compelling need" for the FDA to speedily release Pfizer vaccine data "because a lack of transparency erodes the confidence the medical and scientific community and the public have in the conclusions reached by the FDA."

"During a time when COVID-19 vaccine mandates are being implemented over the objection of those that have questions about the data and information supporting the safety and efficacy of the Pfizer Vaccine, and individuals with these questions are being expelled from employment, school, transportation, and the military, the public has an urgent and immediate need to have access to this data," PHMPT said in its FOIA request.

The group filed a lawsuit in September after the FDA denied their request to expedite the release of its records. In Monday's court filing, the plaintiff and the defendant are seeking a decision from a judge to resolve a dispute over the disclosure schedule for the requested documents.

"The FDA's promise of transparency is, to put it mildly, a pile of illusions," attorney Aaron Siri wrote Wednesday in a blog post about the case.

"It took the FDA precisely 108 days from when Pfizer started producing the records for licensure (on May 7, 2021) to when the FDA licensed the Pfizer vaccine (on August 23, 2021). Taking the FDA at its word, it conducted an intense, robust, thorough, and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure," he wrote.

"While it can conduct that intense review of Pfizer's documents in 108 days, it now asks for over 20,000 days to make these documents available to the public."

The FDA argued in the court filing that to comply with federal law it must redact certain information that is exempt from the records request filed by the plaintiff. Information about Pfizer-BioNTech's confidential business and trade secrets and personal privacy data on patients who participated in clinical trials are examples of documents the FDA is prohibited by law from releasing.

"Reviewing and redacting records for exempt information is a time-consuming process that often requires government information specialists to review each page line-by-line," the FDA told the court. "When a party requests a large amount of records, like Plaintiff did here, courts typically set a schedule whereby the processing and production of the non-exempt portions of records is made on a rolling basis."

The FDA said that court precedent has determined a rate of 500 pages per month to be an efficient response to a large request like the one filed by PHMPT. The agency also said it's FOIA response office does not have enough funding or staff to answer the request at a quicker pace and that if the plaintiff wishes to hurry the process along, the group can do so by narrowing the scope of their document request.

The plaintiff argues the FDA should complete the FOIA request no later than March 3, 2022. "This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer's COVID-19 vaccine," the plaintiff told the court.

"The ability of a majority of Americans to participate in civil society, and even exercise basic liberty rights, are now contingent on receiving this product," PHMPT's lawyers wrote, noting that President Joe Biden's vaccine mandates have made vaccination a condition of employment for millions of Americans.

"There are few whose livelihood, education, service, and participation in civil society are not contingent on a government requirement to receive this product. On this basis alone, basic liberty and government transparency demand that the documents and data submitted by Pfizer to license this product be made available to Plaintiff and the public forthwith, precisely as contemplated by federal regulations," the plaintiff said.

"The entire purpose of the FOIA is to assure government transparency," the plaintiff told the judge. "It is difficult to imagine a greater need for transparency than immediate disclosure of the documents relied upon by the FDA to license a product that is now being mandated to over 100 million Americans under penalty of losing their careers, their income, their military service status, and far worse."

The FDA granted full approval for Pfizer-BioNTech's COVID-19 vaccine on August 23, 2021, under the label Comirnaty.

Earlier this month, a now-former employee of Ventavia Research Group, one of the companies contracted with Pfizer to run its Phase III vaccine clinical trials, made allegations that raised questions about the data submitted before Comirnaty received FDA approval.

Brook Jackson, a former regional director for Ventavia, told the British Medical Journal that her company "falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer's pivotal phase III trial."

After Jackson notified Ventavia of these issues, she emailed a complaint to the FDA and was fired within hours.

According to investigative reporter Paul Thacker, the FDA did not inspect Ventavia's trial sites even though it was alerted to the issues.

Ventavia has since said it is investigating the allegations.

In a statement to the Epoch Times, the FDA declined to comment on the Ventavia matter but said it "has full confidence in the data that were used to support the Pfizer-BioNTech COVID-19 vaccine authorization and the Comirnaty approval."

As of Nov. 17, more than 258,642,454 doses of Pfizer's COVID-19 vaccine have been administered in the United States.

Pfizer says COVID-19 vaccine is 100 percent effective in children as young as 12 years old



Pfizer says that its COVID-19 vaccine is 100 percent effective in preventing coronavirus in children ages 12 to 15 years, according to NBC News.

The Pfizer-BioNTech vaccine has already been approved for use in teens ages 16 years and up.

What are the details?

The company, according to the report, now plans to request emergency use authorization for 12- to 15-year-old in coming weeks following a new study.

The findings, released on Wednesday, have not been peer-reviewed at the time of this reporting.

Pfizer CEO Albert Bourla said that the company hopes to begin using the vaccine on this particular age group ahead of the 2021-2022 school year.

"We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15," Bourla said in a statement on the news.

Uğur Şahin, CEO of BioNTech, added that the results were "encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7" variant of the coronavirus.

The outlet reported that the study, conducted on at least 2,200 young teens, found that just 18 cases of COVID-19 were reported among the teens who received a placebo shot, while the group that received the actual vaccine shot had no positive coronavirus cases at all.

"What's more," NBC reported, "teens in the trial who got the vaccine were later found to have levels of neutralizing antibodies — needed to wipe out the virus — similar to levels in older teens and young adults who had been vaccinated."

CNN reported that the biopharmaceutical companies added that the side effects in the younger teens were similar to that of those experienced by older teens and adults, which include pain at the injection site, fatigue, and fever.

Earlier this month, Pfizer-BioNTech embarked on a global study to test its vaccine in children ages 6 months to 11 years.