Contagion Editorial Team

, the CEO of Pfizer said their COVID-19 vaccine for the Omicron variant will be ready in March. "We [are] already starting manufacturing some of these quantities at risk," Pfizer CEO Albert Bourla said.

 are showing that the COVID-19 vaccines have diminished efficacy against the Omicron variant.

, 2 doses of an mRNA-based vaccine (Pfizer-BioNTech or Moderna) did not adequately neutralize Omicron.

Investigators from the Ragon Institute, MIT, and Harvard created a “pseudovirus” version of Omicron that mimicked its mutations. In the lab, 

 the efficacy of their pseudovirus against blood samples from 239 individuals vaccinated with an initial series of 1 of the 3 COVID-19 vaccines approved in the United States: a 2-dose regimen of Pfizer-BioNTech or Moderna, or a 1-dose regimen of Janssen. The study group also included 70 individuals who received a third dose of an mRNA vaccine.

The investigators found that all 3 vaccines in their primary series produced little to no effective protection against Omicron. They did see potent neutralization against Omicron in those who received an mRNA booster dose.

At the 

, investigators created pseudoviruses that carried key mutations found in the Delta and Omicron strain, and showed that the latter variant was more efficient at evading vaccine-induced antibodies, but that it may not infect the lungs in the same way as previous variants.

“Omicron’s mutations present the virus with a double-edged sword: it’s got better at evading the immune system, but it might have lost some of its ability to cause severe disease,” lead investigator Ravi Gupta, PhD, MPH, professor at the Cambridge Institute of Therapeutic Immunology and Infectious Disease, University of Cambridge, said.

Gupta and his collaborators tested their pseudoviruses against blood samples from vaccinated individuals who had received 2 doses of either the Pfizer-BioNTech or AstraZeneca COVID-19 vaccines.

They reported the new variant required around a 10-fold increase in the concentration of serum antibody to neutralize the variant as compared to the Delta variant. And, in the majority of individuals who were administered 2 doses of the AstraZeneca vaccine, they were not able to neutralize the virus. The investigators said the data were confirmed in live virus experiments.

Although the Omicron strain was shown to be better at evading vaccine-neutralizing antibodies in specific 2-dose vaccines, a silver lining was discovered when they applied a booster dose of the Pfizer-BioNTech vaccine to both groups.

“The Omicron variant appears to be much better than Delta at evading neutralizing antibodies in individuals who have received just two doses of the vaccine,” Gupta stated. “A third dose ‘booster’ with the Pfizer vaccine was able to overturn this in the short term, though we’d still expect a waning in immunity to occur over time.”

At the moment, public health strategy is for people to continue to get vaccinated whether it is the first series or booster doses.

Pfizer’s Bourla said the goal is to offer better protection against emerging variants, but for now, the booster dose appears to be the best way to prevent hospitalization and severe disease.

"The hope is that we will achieve something that will have way, way better protection particularly against infections, because the protection against the hospitalizations and the severe disease — it is reasonable right now, with the current vaccines as long as you are having let's say the third dose," Bourla said.

Articles

Pfizer CEO Albert Bourla made the announcement in an interview.

COVID-19 Vaccine for Omicron Will Be Ready in March Says Pfizer

On Friday, Gilead Sciences announced a voluntary recall of 2 lots of Veklury (remdesivir 100 mg for injection) to the user level. The company received a customer complaint, confirmed by the firm’s investigation, of the presence of glass particulates. 

The 2 recalled lots are the following: 




The company announced the recall and disclosed this risk statement. "The administration of an injectable product that contains glass particulates may result in local irritation or swelling in response to the foreign material. If the glass particulate reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Gilead Sciences Inc. has not received any reports of adverse events related to this recall."

Gilead is reaching out to its distributors and customers via UPS next day air mail to hospital pharmacies and is facilitating the return of any remaining vials from the affected lots. Hospitals that have remdesivir which is being recalled should stop using the affected lots and return the product vials per the instructions.

Consumers with questions regarding this recall can contact Gilead Medical Information at 1-866-633-4474 Monday to Friday 6am - 4pm PST or through their website at 

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

The recall  involves 2 lots of 100 mg of remdesivir for injection to the user level.

Gilead Recalls 2 Lots Of Remdesivir 


The Food and Drug Administration announced it has expanded the authorization of the 2 monoclonal antibodies bamlanivimab and etesevimab so that younger children and even newborns could be administered the therapy who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death.

“Now all patients at high risk of severe COVID-19, including children and newborn babies, have an option for treatment and post-exposure prevention. Children under one year of age who are exposed to the virus that causes COVID-19 may be at particularly high risk for severe COVID-19 and this authorization addresses the medical needs of this vulnerable population,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said. 

In February, the FDA 

 administered together to treat mild-to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high-risk for progressing to severe COVID-19 and/or hospitalization. 

In September, the agency authorized its use for post-exposure prevention of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high-risk for progression to severe COVID-19, including hospitalization or death.

“While today’s authorization includes post-exposure prevention of COVID-19 in children, this therapeutic option is not a substitute for vaccination. Vaccines remain our best tool in the fight against the virus and there is a COVID-19 vaccine authorized for children 5 years of age and above,” Cavazzoni, said.

The agency said the 2 monoclonal antibodies could be used to treat mild to moderate COVID-19 in all younger pediatric patients, including newborns.

FDA Expands Authorization for Bamlanivimab and Etesevimab for Younger Pediatric Population

Today marked the start of the 2-day World Anti-Microbial Resistance Congress 2021, which is being held in Washington, DC. The conference offered on-demand content to view important presentations.

Michael Craig, director, Antibiotic Resistance Coordination and Strategic Unit, National Centers for Emerging and Zoonotic Infectious Diseases, presented his session, Prioritizing Prevention: How We Get Ahead of the Global Threat for of AMR. Craig discussed the prevention lessons learned during the COVID-19 pandemic.

We get what we pay for now. Specifically if we don’t invest in public health capacity and prevention we will not have these when we need them: early detection and containment; response capacity to stop transmission; infection control; and evidence based prevention interventions including vaccines and preventatives; and

Preparedness is not exercises, tabletops and planning documents alone. No amount of hypothetical planning will prepare us for an unknown threat if we cannot address our localized outbreaks and known endemic threats.

Craig then posed the question, if we do not seriously invest in preventing known threats like antibiotic-resistant infections, should we be confident that we can adequately address new emerging threats?

He said the ability to prevent AMR infections is about preparedness. New and emerging threats happen regularly in AMR, and investing in AMR prevention tools provides resiliency. Staff and laboratory well trained to stop current outbreaks. These investments would keep us from dividing our attention when new threats emerge.

Najy Alsayed, MD, head of Disease Area, Infectious Diseases Menarini Group presented his session, The contribution of Real-World-Data in AMR: Which studies and why? Alsayed discussed examining real world data (RWD) and real world evidence (RWE).

For the former, RWD is an umbrella terms to describe :

Effects of disease: patient characteristics, clinical and economic outcomes, health related quality of life

Healthcare interventions (e.g. safety, effectiveness, resource use)

Primary research data: intervention use in routine clinical practice

Secondary research data: from routine practice collected data.

Alsayed pointed out the FDA and EMA use RWD and RWE to monitor post market safety and adverse events to make informed regulatory decisions.

The paradox of AMR, explained Alsayed, was the rise of AMR and the increasingly thin new antibiotic availability. He pointed at that from 1983 to 1987 there were 16 new antibiotic agents and that from 2008 to 2012 there were only 2 new antbiotics.

He went on to say there were a number of reasons for this including suboptimal new antibiotic approval and poor patient access to antimicrobials.

Alsayed pointed to three areas where RWD contributions may improve access to new antimicrobials, including:

Allowing rational use vs current rationed use

Allowing targeted patient treatment approach

Demonstrating new antimicrobials benefit to both patients and the healthcare system.

Highlights from the sessions of the World Anti-Microbial Resistance Congress 2021 included addressing the global threat for AMR and looking at real world data and real world evidence to deter resistance.

How Real World Data and Preparedness are Needed in Fight Against for AMR

Orlando, Fla-based Profounda announced the Food and Drug Administration (FDA) approved an Orphan Drug Designation for the use of the company’s therapy, miltefosine (Impavido), to treat invasive candidiasis.

 which is an emerging multidrug resistant yeast that can cause invasive candidiasis and is associated with high mortality," Michael MacLaughlan, vice president of operations, Profounda, stated. “Additional treatment options are needed for invasive Candidiasis to allow for a potentially successful treatment

Miltefosine is an FDA-approved, oral treatment for visceral, mucosal and cutaneous leishmaniasis in patients 12 years of age and older. In the United States, leishmaniasis may be seen in returning travelers following exposure in endemic regions, and in American soldiers serving in Asia and the Middle East. According to the Centers for Disease Control and Prevention, Leishmaniasis is a parasitic disease.

In addition to the approval for the treatment of Leishmanias, miltefosine has also received orphan drug designation in treating the free-living infection primary amebic meningoencephalitis (PAM), the brain infection caused by the water-born amoeba Naegleria fowleri, Granulomatous Amebic Encephalitis (GAE) and also for Acanthamoeba Keratiti.

Miltefosine is an alkyllysophospholipid analogue drug with in vitro activity against the promastigote and amastigote stages of Leishmania species. Miltefosine was included in the World Health Organization’s essential medicines list as an anti-leishmaniasis medicine in March 2011.

The therapy can be used for the treatment of invasive candidiasis.

FDA Grants Orphan Drug Designation Approval for Miltefosine

The C Diff Foundation is hosting its 9th Annual International C Diff  Conference and Health EXPO this Thursday and Friday.  There will be over 40 international topic-experts dedicated in disciplines of healthcare, pharma, biotech, and academia. 

Presenters will deliver data and discuss critical information on Clostridioides difficile in live online presentations. There will be on-demand poster presentations, exhibitors, and real-time networking opportunities available. 

“The annual C Diff Foundation conference is a highlight of my learning year. The combination of academia, pharmaceutical, and governmental representation creates a learning environment that is second to none,"Paul Feuerstadt, MD, FACG, AGAF, stated. "I went initially in 2014 and have circled the conference dates on my calendar annually as immobile. The timing during C. difficile awareness month is tremendous as it summarizes all of the newest findings throughout the year.” 

The conference is virtual and registration is complimentary this year. 

To learn more about the conference, guest speakers, and the diverse topics being presented visit 

The organization is hosting its 9th Annual International C Diff Conference and Health EXPO on Thursday and Friday this week. The conference is virtual and free to the public.