This week of March 27, 2022, we keep close watch on discussions surrounding the emergency approval of vaccines for kids aged at least 6 months, as well as additional doses for seniors
MANILA, Philippines – Infections continue to decline in the Philippines, with all regions in the country now a “minimal risk” for COVID-19. Hospital admissions for critical to cases have also dropped from 1,874 in mid-January to 805 in the recent severe week.
Roughly 60% of Filipinos are fully vaccinated. Among the 43.8 million people eligible for boosters, 11.6 million have gotten their additional shot.
Here’s what we’re watching this week of March 27, 2022:
Moderna recently announced that it would seek the emergency authorization of the United States Food and Drug Administration (FDA) for its vaccine for children aged 6 months to 6 years old. The group is currently inligible to receive any COVID-19 shot.
- Moderna’s decision to ask for emergency use of its vaccine comes after interim results from two clinical trials showed that two doses of the vaccine generated immune responses (among infants aged at least 6 months and kids aged at least 6 years) similar to those seen among adults aged 18 to 25.
- But the two dose regimen had a lower efficacy in preventing infections compared to results seen in earlier trials for older groups. In the context of Omicron, Moderna said the results of the trials for this age group would be on par with what would be expected for adults against the highly contagious variant.
- Among children 6 months to 6 years old, Moderna tested shots with a 25 microgram dosage (one-fourth the amount given to adults), given 28 days apart.
- Specifically, STAT news reported: “In children 6 months to 23 months, cases of Covid were decreased 43.7%; they were decreased by 37.5% in the 2 years to under 6 years age group.”
- As for other endpoints, “There were no severe cases, hospitalizations, or deaths in the studies, so the company could not estimate how protective the vaccine was in young children against those outcomes.”
- Forty percent protection against infection can still be useful for some kids, like those who may have higher risks.
- A reality check would be in order, too. “There may still be some benefit in using these vaccines, but it will then be tricky and important to make sure that people understand the limitations of what can be said about the vaccines and the limitations in what to expect the vaccines to do,” Phil Krause, a former deputy director of the FDA’s office of vaccines, told STAT.
- Are the numbers too low? Earlier in the pandemic, the guidance provided by the FDA and the World Health Organization to manufacturers was to produce vaccines that had an efficacy of at least 50% against infection. But that was before Omicron. “Most, probably, would not have passed muster had Omicron emerged while their initial clinical trials were underway,” STAT noted.
- It may be the case that a third shot is needed in children. Moderna said it will study boosters for children in this group like it is for older kids. Pfizer is studying a third shot in this age group, too, and had put off earlier plans to apply for emergency use precisely to test a three-dose regimen.
- Developments in the US FDA are closely watched by Philippine experts and officials as the Philippine FDA only accepts vaccine applications for vaccines or drugs that have been granted emergency approval in their respective countries or mature and established FDAs, like that of the US.
- Currently, the 11.1 million children aged below 5 are the only group that cannot yet get vaccinated.
DOH supports a 4th dose
In the last week, the Department of Health announced it submitted an application to amend the emergency use authorization of COVID-19 vaccines to include a fourth dose for vulnerable individuals.
- If granted, the fourth dose will be endorsed only for elderly and immunocompromised individuals, not the rest of the population.
- The move follows that of other countries, like Australia, El Salvador, Germany, Israel, and the United Kingdom. These countries have also limited the additional shot to the elderly and high-risk or those who have pre-existing conditions.
- Israel, in particular, has been offering a fourth dose for some time, allowing for the generation of some data that sheds light on its performance:
- A preprint that assessed the rates of infection and severe illness among some 1.1 million Israelis at least 60 years old found that a fourth dose made meaningful impact for the group with the rate of severe disease made four times lower, and infection, two times lower.
- Another study among health workers found that while antibodies significantly fell five months after a third shot, a fourth shot boosted it back up.
- For the young population, the same study found that immunogenicity or the ability of a substance (in this case, a vaccine) maxes out at three doses. Epidemiologist Katelyn Jenna wrote in a newsletter on the findings: “They…assessed the efficacy of the fourth dose compared to the third dose, and the added benefit was not statistically significant. In other words, the efficacy of a fourth dose was no different from the efficacy of a third dose.”
- While it’s not wrong to keep in step with the latest vaccine developments, in the Philippines the possibly of a fourth dose comes as some 2.6 million elderly Filipinos have yet to get a single dose at all. Most experts we’ve spoken to agree that, in a hierarchy of goals, reaching them should remain a priority.
- Continuously boosting isn’t a very attractive option for many reasons, too, including how resource intensive it can be and how it remains a short-term solution. This makes research on a universal vaccine, nasal vaccines, or other responses that target different parts of our immune system more urgent.
Sinovac boosters needed for older people
A new study by scientists at the University of Hong Kong found that while two doses of Sinovac’s vaccine offered a moderately high level protection for the elderly, a third shot significantly strengthens defenses against severe disease and death.
- Findings, which have yet to be peer-reviewed, were based on patients who were infected during the Omicron wave in the city. The New York Times summarized what they found:
- “A Sinovac booster shot helped significantly, proving to be 98% effective against severe or fatal Covid among people at least 60 years old.”
- For younger people, the Times reported of the study: “Sinovac’s vaccine performed similarly to Pfizer’s among younger people, even without a booster dose…. In people younger than 60, two Sinovac doses were roughly 92% effective against severe or fatal Covid, whereas two Pfizer doses were about 95% effective.”
- The findings support what most experts in the Philippines said in the early days of the vaccine drive – that when looking at performance of vaccines against severe outcomes, shots performed on the same level.
- Data from the study likewise underscores the need for the elderly to get boosted to help tame infections among the high-risk group. This is especially true for the Philippines, where Sinovac has made up a significant bulk of vaccinations, especially in the early months of the program, when vaccinations were open to limited groups, including the elderly, supplies of doses were lacking, and use of the shot had been expanded to include senior citizens.
In case you missed it: The recent Commission on Elections debate showed that most presidential candidates were finally looking at long-term to address the pandemic – a welcome development, considering COVID-19 isn’t going away.
New proposals put forward on the debate stage included increasing the budget for local research and development, raising vaccination targets, and providing bigger funding to both sustain and improve the current COVID-19 response measures. Catch up here: