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Co-administration of influenza and COVID-19 vaccines shown to be effective

17th June 2021

Whether co-administration of a COVID-19 and influenza vaccine leads to immune interference is unclear but possibly relevant for future vaccination programmes.

The international rollout of the COVID-19 vaccination programme is starting to break the link between infection and severe illness and hospitalisation. Whether or not an annual booster COVID-19 vaccination will be required in the future is yet to be determined. Nevertheless, in some countries, it is possible that the COVID-19 vaccination schedule could overlap with the influenza season, with a potential for an overlap in vaccine administration. As the Phase III COVID-19 vaccination trials excluded those who had a recent or planned receipt of another vaccine, there is a lack of data on the impact of co-vaccination. This led a team from the Novavax Institute, Gaithersburg, USA and St George’s University Hospital, London, UK, to consider the effect of simultaneous administration of the first dose of the NVX-CoV2373 (Novavax COVID-19 vaccine) and an influenza vaccination, in a subgroup of patients included in the Phase III efficacy trial of NVX-CoV2373. Subgroup patients were required to be in good health and not already received an influenza vaccination or any other live vaccine within 4 weeks. These individuals were randomised to receive a concomitant dose of influenza with their first NVX-CoV2373 dose or influenza and placebo. Although the main study was observer-blind, the influenza vaccine was administered in an open-label manner and reactogenicity was evaluated using an electronic diary for 7 days post-vaccination and the team assessed the antibody titres to both influenza and COVID-19 after 21 days.

Although the main trial recruited over 15,000 participants, only 431 were randomised to influenza vaccine or placebo. A total of 217 participants with a mean age of 39 years (43.3% female) and 75.1% of White ethnicity received the seasonal influenza vaccine and 214 received the influenza vaccine and placebo. Reactogenicity was more common in the co-vaccinated group compared to NVX-CoV2373 alone, with 70.1% versus 57.6% reporting tenderness, pain at the injection site (39.7% vs 29.3%), fatigue (27.7% vs 19.4%) and muscle pain (28.3% vs 21.4%). Although the influenza vaccine response was satisfactory, the COVID-19 vaccine efficacy was 87.5% in the co-vaccinated subgroup compared with 89.8% in the main group. The rates of adverse effects were low and balanced between those given NVX-CoV2373, influenza vaccine or both.

Commenting on these findings, the authors noted how this was the first direct evidence that co-vaccination still resulted in acceptable vaccine efficacy. While there was an increase in the reported incidence of local reactogenicity in the co-vaccinated group, symptoms were generally mild in severity. They concluded that the study had generated to early safety concerns over co-vaccination.

Toback S et al. Safety, immunogenicity and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines. MedRxiv 2021

Immunogenicity occurs in pregnant and lactating women after COVID-19 vaccination

17th May 2021

Real-world data indicate that both pregnant and breast-feeding women are able to generate a satisfactory immune response after vaccination against COVID-19.

With pregnant women excluded from the COVID-19 vaccination trials, it remained uncertain whether those who were either pregnant or breast-feeding would develop satisfactory immunogenicity, especially given the evidence of more severe outcomes after infection in those who are pregnant. While there are some data to indicate that vaccination against other viruses such as influenza confers immunity, much less is known about COVID-19 vaccination and the efficacy in lactating mothers. In addition, with the emergence of an increasing number of COVID-19 variants, there is an urgent need to examine whether a sufficient antibody titre against COVID-19 and new variants is generated within these two patient cohorts. Consequently, a team from the Department of Obstetrics and Gynaecology, Boston, US, set out to answer this question prospectively following up on a number of women who received a COVID-19 vaccination between December 2020 and March 2021. The team also included a group of pregnant/non-pregnant women/unvaccinated women who had been previously infected with COVID-19 and who provided serum samples for comparative purposes.

A total of 103 participants were enrolled in the study comprising 57 who were non-pregnant, 30 pregnant and 16 lactating women. The median age of the pregnant and lactating women was 35 years and the majority (over 80%) were of white ethnicity. Most (63%) pregnant women had received the mRNA-1272 (Moderna) vaccine whereas the majority of lactating mothers (69%) had the BNT162b vaccine. Serum samples were taken a median of 21 days after the second vaccination dose for non/pregnant individuals and 26 days for lactating mothers. In addition, nine women gave birth and contributed infant cord blood. The level of receptor-binding domain (RBD) antibody titres in non-pregnant, pregnant and lactating were similar but higher than among those who had a prior COVID-19 infection, irrespective of pregnancy status. In cord samples, the levels of RBD antibodies were similar in mothers compared to cord samples (14,953 vs 19,873) among those who had been vaccinated but lower in non-vaccinated, but previously infected women (1342 vs 635). Interestingly, there were higher median levels of antibodies in breast milk among those who had a prior infection compared to vaccinated women (203 vs 97). Although RBD antibodies to the wild-type COVID-19 were comparable across the different groups, there was a 3.5-fold lower titre against the B.1.1.7 (UK variant) and a 6-fold lower titre for the B.1.351 (South African variant). Despite these lower titre levels, responses to non-neutralising antibodies and T-cell responses were preserved in both pregnant and non-pregnant women to the variants of concern, suggesting that cellular immune responses may be important for protection.

Commenting on these results, the authors noted how their data confirm other findings of a higher vaccine-induced antibody response compared to prior infection.

They concluded that while the results are based on a small sample size, the presence of neutralising antibodies in both cord and breast milk samples reveals how newborns are protected by maternal vaccination.

Collier AY et al. Immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating women. JAMA 2021