John Parkinson

The company announced this morning it had filed for a request for an Emergency Use Authorization (EUA) with the Food and Drug Administration (FDA) for two 25 μg doses of the primary series of their mRNA-1273 vaccine for children 6 months to under 2 years and 2 years to under 6 years of age.

The company said it had reached its met primary endpoint with robust neutralizing antibody titers similar to adults in their phase 2/3 KidCOVE study.

"We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children," Moderna CEO Stéphane Bancel, said in a statement. "We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers."

A few weeks ago, Moderna announced its topline data for the KidCOVE phase 2/3 study. The 

 had been ongoing for several months, and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA).

Moderna reported that the Omicron variant was the predominant strain in the United States during this study in the younger age groups. The secondary endpoint of vaccine efficacy confirms statistically significant, but lower efficacy against COVID-19 infection as expected during the Omicron wave and consistent with adult observational data.

Using the phase 3 COVE study COVID-19 definition, vaccine efficacy in children 6 months to 2 years was 43.7% and vaccine efficacy was 37.5% in the 2 to under 6 years age group. The majority of cases were mild, and no severe COVID-19 disease was observed in either age group. The absence of any severe disease, hospitalization or death in the study precludes the assessment of vaccine efficacy against these endpoints.

When the analysis was limited only to cases confirmed positive for SARS-CoV-2 by central lab RT-PCR vaccine efficacy remained significant at 51% (95% CI: 21-69) for 6 months to <2 years and 37% (95% CI: 13-54) for 2 to <6 years. These efficacy estimates are similar to vaccine efficacy estimates in adults against Omicron after two doses of mRNA-1273.

The company said its EUA submission will be complete next week, and that they are studying booster doses for all pediatric cohorts.

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Moderna has filed for the first FDA Emergency Use Authorization for this age group.


Children 6 Months to 6 Years 1 Step Closer to a COVID-19 Vaccine

With masking regulations being reinstated recently and also being struck down in federal court, mass confusion is setting in as the general public doesn’t know where they are required to wear masks.

For example, in the city of Philadelphia, where they 

 that went into effect on Monday, people who are the local mass transit, Septa, getting to the Philadelphia airport, they do not need to wear masks. However, if you are in the airport, you need to wear a mask. Getting on a plane is a different matter, dependent on which airline you fly and the masking rules. Confused yet?

From a federal standpoint, the Biden Administration recently extended the mask mandate when traveling on buses, trains, and planes until May 3. "Since early April 2022, there have been increases in the 7-day moving average of COVID-19 cases in the United States. ... TSA will continue to coordinate closely with CDC and communicate any changes to this requirement with the public,” the Transportation Security Administration (TSA) announced in a statement.

However, a federal judge in Florida ruled against the masking mandate on Monday, and with that, federal officials said the mandate is not in place until it gets legally squared away.

In light of this latest news, several of the major airline carriers are making masks optional including Alaska Airlines, American Airlines, Delta Air Lines, United Airlines, Southwest Airlines, and JetBlue.

Just to be on the safe side, keep you mask handy with you when you walk out the door to deal with this confusion.

Masking during airline travel was halted yesterday by a federal judge, while other places, like Philadelphia, have re-implemented masking mandates.


Need a Mask or Not? Regulations Confuse Travelers 

Food and Drug Administration (FDA) has amended its Emergency Use Authorizations (EUA) for both mRNA vaccines to now include a second booster dose allowing adults 50 years and older the ability to receive the additional shot.

The federal agency says this action now makes a second booster dose available to populations at higher risk for severe disease, hospitalization, and death.

FDA amended the EUAs as follows:

A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.

A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise.

A second booster dose of the Moderna COVID-19 Vaccine may be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the same certain kinds of immunocompromise.

"Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

FDA made it clear in its statement this is only applicable to the Moderna and Pfizer-BioNTech vaccines, and the agency also reiterated the recommendation to get a booster shot for those who have not had one yet.

“Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19,” Marks also stated. “So, those who have not received their initial booster dose are strongly encouraged to do so.”

The FDA authorized a second booster for both Pfizer and Moderna vaccination recipients 4 months after first booster shot. 

Second Booster Shot Authorized by FDA for Patients 50 and Over

This article was originally published in 

Moderna announced today that 2 doses of their mRNA-1273 COVID-19 vaccine in children at 6 months and under 6 years of age demonstrated robust neutralizing antibody titers, meeting the study's primary endpoint. The dosing was at 25 μg, which is half the antigen amount of the adult population being utilized for vaccination, yet had a similar amount of titers according to the company’s statement.

These results come from the company’s KidCOVE phase 2/3 study.

"We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age. We now have clinical data on the performance of our vaccine from infants six months of age through older adults," Moderna CEO Stéphane Bancel, said. "Given the need for a vaccine against COVID-19 in infants and young children we are working with the US FDA and regulators globally to submit these data as soon as possible."



 has been ongoing for several months, and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA).

Moderna reports that the Omicron variant was the predominant strain in the Unite States during this study in the younger age groups. The secondary endpoint of vaccine efficacy confirms statistically significant, but lower efficacy against COVID-19 infection as expected during the Omicron wave and consistent with adult observational data.

Using the Phase 3 COVE study COVID-19 definition, vaccine efficacy in children 6 months to 2 years was 43.7% and vaccine efficacy was 37.5% in the 2 to under 6 years age group. The majority of cases were mild, and no severe COVID-19 disease was observed in either age group. The absence of any severe disease, hospitalization or death in the study precludes the assessment of vaccine efficacy against these endpoints.

Moderna is also submitting data to modifying their current vaccine in older children and teens.

“After consultation with the U.S. FDA we have initiated a submission for emergency use authorization of our COVID-19 vaccine in children ages 6 to under 12 years old and are updating our submission to the FDA for emergency use authorization of mRNA-1273 in adolescents ages 12 to 17 years with additional follow-up data,” Bancel said.

For children between 6 years to under 12 years, the company’s EUA submission is for a 50 μg two-dose primary vaccine series.

The dose is half the antigen amount for adults but with similar amount of titers. 

Moderna's Vaccine for Children 6 Months to 6 Years Meets Primary Endpoint in Phase 2/3

Moderna announced yesterday it has submitted its amended application for an Emergency Use Authorization to the Food and Drug Administration (FDA) to include its Spikvax COVID-19 vaccine for a fourth booster dose for people 18 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines.

This development comes shortly after Pfizer applied for an EUA for a fourth dose of its COVID-19 vaccine.

As concerns of the 

 called “Deltacron” or “Stealth Omicron,” which appears to be the most contagious strain thus far, and some medical experts calling it as contagious as measles, as well as cases growing in China and Europe, there have been calls for proactive steps such as offering another booster shot to protect people.

American public health officials are watching this variant, but have not changed guidance on mask-wearing or other prevention measures for the moment.

 the Moderna vaccine as a 2-dose primary series for persons 18 years of age and older.

“Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death,” Moderna CEO Stéphane Bancel, said at the time. “The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus.”

Moderna's vaccine has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel, according to Moderna.

In late January, the company announced it had begun its phase 2 clinical trial extension for its Omicron-specific booster (mRNA-1273.529) vaccine candidate. Moderna said it was an extension of an earlier study that will evaluate the immunogenicity, safety, and reactogenicity of mRNA-1273.529 as a single booster dose in adults aged 18 years and older.

The FDA approved the Moderna vaccine as a 2-dose primary series for persons 18 years of age and older earlier this year.

EUA Submitted for Moderna COVID-19 Vaccine Amendment for Fourth Dose

Yesterday, on the nationally broadcast television show, 

, Pfizer CEO Albert Bourla said he expected people to need a fourth dose of the vaccine to prevent another wave of COVID-19.

 found that 3 doses of the Pfizer-BioNTech (BNT162b2) or AstraZeneca (AZD1222) COVID-19 vaccines effectively neutralized the Omicron variant.

However since the emergence of Omicron in the last few months, waning protection in the vaccines has been a developing issue as the case loads increased in the early part of 2022.

Pfizer has been working on a booster dose to address the variants.

"The variants are coming," Bourla said. "Omicron was the first to be able to evade in a skillful way the immune protection we were given, but we also know the duration of the protection doesn’t last very long. What we are trying to do—and we are working very diligently right now—is to not only make a vaccine that protects against all variants including Omicron but something that also protects for a year."

When asked if a fourth dose was necessary, Bourla said, ”It is necessary a fourth booster, right now; the protection we are getting from the third is good enough; it is actually quite good for hospitalizations and deaths; it’s not that good against infections.”

No timeline has been set for the booster dose for the variants yet, but Bourla says the company will be ready with the manufacturing whenever a decision is made.

In the same interview, he said we are going to have to learn how to live with the virus. When asked if he thought if the COVID-19 vaccine would need to be administered annually like the influenza vaccine Bourla said, “I think so."

Pfizer CEO, Albert Bourla, said in nationally televised interview that it is necessary to fend off waning protection.