CMAAO Coronavirus Facts and Myth Buster: Moderna files for emergency vaccine approval

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1180: Moderna Filing for FDA Emergency Vaccine Approval, Reports 94.1% Efficacy

[Medscape Excerpts]

The Moderna COVID-19 vaccine was found to be 94.1% effective in the final analysis of its 30,000-participant phase 3 study. The company has filed for an emergency use authorization (EUA) from the Food and Drug Administration (FDA).

Eleven individuals in the mRNA-1273 vaccinated group later tested positive for COVID-19, compared with 185 participants given two placebo injections, yielding a point estimate of 94.1% efficacy. This finding is in line with the 94.5% efficacy in interim trial results that were announced on November 16.

The vaccine prevented serious cases of infection. All 30 severe infections were noted among those randomly assigned to placebo. The FDA will review the vaccine safety and efficacy data at the next Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on December 17. If and when approved, healthcare providers will be able to use the new 91301 CPT code specific to mRNA-1273 vaccination.

Vaccine efficacy was consistent across different groups analyzed according to age, race/ethnicity, and gender. The 196 COVID-19 cases in the trial included 33 adults above 65 years of age and 42 individuals from diverse communities, including 29 Hispanic or Latinx, six Black or African Americans, four Asian Americans, and three multiracial participants.

The vaccine appeared to be generally well tolerated with no serious safety concerns identified thus far, the company reported.

The most common solicited adverse events in a previous analysis included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. These solicited adverse reactions appeared to increase in frequency and severity after the second dose. A continuous review of safety data is under process.

One COVID-19-related death in the study was reported in the placebo group.

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA

CMAAO Coronavirus Facts and Myth Buster: Antibodies in Newborn

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With input from Dr Monica Vasudev

1179: Singaporean woman who had COVID-19 gives birth to baby with coronavirus antibodies

The baby of a woman from Singapore who contracted the coronavirus infection in March, when she was 10 weeks pregnant, was born with antibodies but no disease.

Celine Ng-Chan, aged 31, contracted COVID-19, along with her mother, 58-year-old Choy Wai Chee, and 2-year-old daughter, while they were on holiday in Europe in March. Her mother spent 29 days on life support. Ng-Chan and her daughter, Aldrina, had mild infection. Her husband and son did not get infected.

In February, a 1-day-old baby became the youngest patient to contract COVID-19, and was the first suspected case of mother-to-child transmission. In a study from China, three out of 33 pregnant, infected women gave birth to babies who had COVID-19. All three babies recovered.

In July, another study added to the available evidence that coronavirus can be passed from pregnant women to their fetuses and newborns. However, the study had only 31 participants and was too small to be conclusive.

Ng-Chan herself was not having antibodies by the time Aldrin was born.

The National Institute of Medical Sciences, Singapore has noted that thus far, no virus was present in the fluid surrounding the womb nor in her breast milk. China has confirmed that women with COVID-19 give birth to children with antibodies. A medical journal that reports on Pediatrics has stated that it is rare for a new born to contract COVID-19 from its mother. The same has been reconfirmed by the National Institute of Medical Sciences, Singapore.

The World Health Organization has stated that it is not yet known if a pregnant woman with coronavirus can pass it to her fetus or baby during pregnancy or delivery.

[Sources: nydailynews.com; covaipost.com; theprint.in]

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA

CMAAO Coronavirus Facts and Myth Buster: Vaccine Difficulties

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1178: COVID-19 vaccine difficulties

Issues

  1. Studies have not shown yet whether the vaccine can prevent transmission of SARS-CoV-2.
  2. It is not known if people can become infected and transmit even with vaccination. Those who have been vaccinated could still continue to asymptomatically and unknowingly shed virus and spread the disease. The data from the Pfizer/BioNTech and Moderna vaccines describe protection from symptomatic disease. Pfizer reported170 infections (162 in the placebo group) in 41,000 participants. Moderna has reported 95 cases (90 in the placebo group) thus far in 30,000 participants.
  3. The level of nasal carriage required for infection, and the duration of that, are not known. It is also not clear what the vaccine does on that.
  4. People can expect to still be wearing masks and follow non-pharmaceutical public health measures. People may start eating in restaurants, going to theatres, and sporting events without masks.
  5. Data should look at the duration of viral shedding and the amount of virus in nasopharyngeal swabs or nasal swabs over time.
  6. Herd immunity will require 80% coverage, and that is not likely to happen until summer of 2021.
  7. We can get there, and we have the doses, but there may be a significant proportion of people who turn them down; then this epidemic goes on and on and on. Brazilian President Jair Bolsonaro has said that he will not take a coronavirus vaccine.
  8. A former Vice President and Chief Scientist of Pfizer, Dr. Michael Yeadon, in anarticle published in Lockdown Sceptics, wrote that there is no need for vaccines to eliminate the pandemic.
  9. Oxford trial errors tells how the trials are being conducted.
  10. With mucosal infections, one is expected to see less protection. Influenza vaccines, in a good season, offer nearly 60%. Enteric (intestinal) infection vaccines can provide 85-90% protection, but not in all parts of the world. Injectable polio vaccines for a mucosal infection is particularly good but it does not really protect against the mucosal component, the enteric tract.
  11. Will it work in younger people?
  12. Will it work in people who are immunocompromised?
  13. Can you give these vaccines to pregnant women?
  14. What would their safety record be?
  15. How long does protection last?
  16. What does the immune response look like?
  17. What is the B-cells component?
  18. RNA is very inflammatory. More reactions were seen in people who got the highest dose in the Moderna trial, and that dose is not being used for further studies.
  19. UNIP does not have a vaccine as expensive as the AstraZeneca vaccine $3 a dose.  The country needs something under 50 cents.
  20. We need single dose candidates: Vectored vaccines — measles, VSV or vaccines with an adjuvant. Bio E is collaborating with the Baylor College of Medicine on a protein-based candidate. Janssen’s vaccine is an adenovector vaccine which is planned as a single dose because it is a replicating vector. Bio E is also working with them.
  21. Every mRNA vaccine is different. While the sequence coding for the stabilized spike may be the same, when making a vaccine, which is either enclosed within a lipid nanoparticle or integrated with it, one will have different levels of stability.
  22. 2-6-degree temp: Gennova Biopharmaceuticals (mRNA vaccine); CureVac [Germany]; Pfizer is planning to modify its formulation. If there is a need for cryo-vials, then special kinds of glass is needed.
  23. Auto-disabled syringes are costly. Glass vials are a challenge. We will need enough rubber stoppers and the aluminum foil that goes on top of the injection vials.
  24. If we need to have vaccine vial monitors (VVMs) to monitor the temperature of vaccines and excursions, only one company in the world is authorized to make them.
  25. mRNA vaccines — need sufficient nucleotides to manufacture the RNA on the scale that people want.
  26. Failures of batches are a fact in the development of vaccines. Whether that will happen with mRNA?

[Sources: Medscape; Reuters; Healthwire; The Indian Express]

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA

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