India’s COVID-vaccine woes — by the numbers

Padma, T. V.

doi:10.1038/d41586-021-00996-y

Cited by 32 publications

(19 citation statements)

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“…1 Although there are now 24 different vaccines approved worldwide, manufacturing issues, raw material shortages, and surges in infection have led to supply chain disruption and delays. 2 , 3 , 4 The emergence of new safety concerns with available vaccines led to changes in vaccine deployment policy. In early 2021, multiple countries implemented age restrictions for the ChAdOx1 n-CoV-19 vaccine (AstraZeneca, hereafter referred to as ChAd) after the emergence of vaccine-induced thrombocytopenia and thrombosis, and recent pauses in immunisation of young people with mRNA vaccines due to concerns about myocarditis.…”

Section: Introductionmentioning

confidence: 99%

Immunogenicity, safety, and reactogenicity of heterologous COVID-19 primary vaccination incorporating mRNA, viral-vector, and protein-adjuvant vaccines in the UK (Com-COV2): a single-blind, randomised, phase 2, non-inferiority trial

et al. 2022

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Background Given the importance of flexible use of different COVID-19 vaccines within the same schedule to facilitate rapid deployment, we studied mixed priming schedules incorporating an adenoviral-vectored vaccine (ChAdOx1 nCoV-19 [ChAd], AstraZeneca), two mRNA vaccines (BNT162b2 [BNT], Pfizer–BioNTech, and mRNA-1273 [m1273], Moderna) and a nanoparticle vaccine containing SARS-CoV-2 spike glycoprotein and Matrix-M adjuvant (NVX-CoV2373 [NVX], Novavax). Methods Com-COV2 is a single-blind, randomised, non-inferiority trial in which adults aged 50 years and older, previously immunised with a single dose of ChAd or BNT in the community, were randomly assigned (in random blocks of three and six) within these cohorts in a 1:1:1 ratio to receive a second dose intramuscularly (8–12 weeks after the first dose) with the homologous vaccine, m1273, or NVX. The primary endpoint was the geometric mean ratio (GMR) of serum SARS-CoV-2 anti-spike IgG concentrations measured by ELISA in heterologous versus homologous schedules at 28 days after the second dose, with a non-inferiority criterion of the GMR above 0·63 for the one-sided 98·75% CI. The primary analysis was on the per-protocol population, who were seronegative at baseline. Safety analyses were done for all participants who received a dose of study vaccine. The trial is registered with ISRCTN, number 27841311. Findings Between April 19 and May 14, 2021, 1072 participants were enrolled at a median of 9·4 weeks after receipt of a single dose of ChAd (n=540, 47% female) or BNT (n=532, 40% female). In ChAd-primed participants, geometric mean concentration (GMC) 28 days after a boost of SARS-CoV-2 anti-spike IgG in recipients of ChAd/m1273 (20 114 ELISA laboratory units [ELU]/mL [95% CI 18 160 to 22 279]) and ChAd/NVX (5597 ELU/mL [4756 to 6586]) was non-inferior to that of ChAd/ChAd recipients (1971 ELU/mL [1718 to 2262]) with a GMR of 10·2 (one-sided 98·75% CI 8·4 to ∞) for ChAd/m1273 and 2·8 (2·2 to ∞) for ChAd/NVX, compared with ChAd/ChAd. In BNT-primed participants, non-inferiority was shown for BNT/m1273 (GMC 22 978 ELU/mL [95% CI 20 597 to 25 636]) but not for BNT/NVX (8874 ELU/mL [7391 to 10 654]), compared with BNT/BNT (16 929 ELU/mL [15 025 to 19 075]) with a GMR of 1·3 (one-sided 98·75% CI 1·1 to ∞) for BNT/m1273 and 0·5 (0·4 to ∞) for BNT/NVX, compared with BNT/BNT; however, NVX still induced an 18-fold rise in GMC 28 days after vaccination. There were 15 serious adverse events, none considered related to immunisation. Interpretation Heterologous second dosing with m1273, but not NVX, increased transient systemic reactogenicity compared with homologous schedules. Multiple vaccines are appropriate to complete primary immunisation following priming with BNT or ChAd, facilitating rapid vaccine deployment globally and supporting recognition of such schedules for vaccine certification. Funding UK Vaccine Task Force, Coalition for Epidemi...

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Section: Introductionmentioning

confidence: 99%

Immunogenicity, safety, and reactogenicity of heterologous COVID-19 primary vaccination incorporating mRNA, viral-vector, and protein-adjuvant vaccines in the UK (Com-COV2): a single-blind, randomised, phase 2, non-inferiority trial

et al. 2022

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“…The world's largest manufacturer of vaccines, the Serum Institute of India (SII) in Pune, was expected to produce 100 million doses per month and to contribute significantly to COVAX. However, after a fire broke out at a facility in January, its production capacity was severely affected, currently standing at roughly 60 million doses per month [72]. The SII was given the license to manufacture one billion doses of Covishield by AstraZeneca last June, to fulfill the vaccine requirements of low and middle-income countries.…”

Section: Vaccine Manufacturing Challengesmentioning

confidence: 99%

Vaccine Development against COVID-19: Study from Pre-Clinical Phases to Clinical Trials and Global Use

et al. 2021

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As per the World Health Organization (WHO), more than 288 vaccines against COVID-19 are being developed, with an estimated 184 being presently investigated in the pre-clinical phases, while 104 of these vaccine candidates are at various stages of clinical trials. Twelve of these are in the advanced stages of clinical investigation, and promising results in the phase 3 trials have already paved the way for their regulatory approval and subsequent dissemination for global use. Preliminary and interim results of some of these candidate vaccines are being analyzed for public dissemination. Some of these vaccines have already been rolled out to immunize not only the highest risk individuals but also the general population in several countries. Once their safety and efficacy are established, the next limiting step would be their mass manufacturing by the pharmaceutical companies to fulfill the global demand. The challenge of manufacturing billions of doses of high-quality vaccines is under-appreciated at the moment. A massive vaccination drive would be needed to protect people of all ages. The timely and coordinated execution of the vaccination effort would require unprecedented coordination at the national and international levels for generating funds to purchase the required doses of vaccines, fair distribution of doses and managing the mechanics of delivering vaccines throughout the world.

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“…Officials in South Africa announced that 1 million AstraZeneca vaccines would be delivered in January and another 500,000 doses in February from the Serum Institute of India [ 10 ]. However, due to the rising surge of COVID-19 cases, India ceased export of Oxford/AstraZeneca COVID-19 vaccines to other countries [ 11 ]. Thus, anticipated vaccine orders were largely left unfilled in South Africa and likely contributes to the substantially lower vaccination rates.…”

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confidence: 99%

Disparities in global COVID-19 vaccination rates & allocation of resources to countries in need

Sen-Crowe

McKenney

Elkbuli

2021

Annals of Medicine &Amp; Surgery

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As of July 20th, 2021, over 191 million confirmed COVID-related cases and 4.1 million COVID-related deaths have been documented across the globe. Vaccines were initially prioritized in healthcare workers (HCWs) and elderly populations to provide protection to high-risk individuals. However, despite the intra-and-international distribution of COVID-19 vaccines, there is considerable variability in the vaccination rates observed worldwide. For example, the United Arab Emirates reported 166 vaccine doses/100 population, whereas most of the countries in Africa have administered <10 doses/100 population. The inadequate supply of vaccinations in addition to the lack of swift distribution/reallocation of vaccines that arrived likely contribute to the low vaccination rates observed in Africa. The US and many countries in Europe began administering vaccines in December 2020, whereas the majority of countries in Africa began administering vaccines in March 2021. In order to mitigate COVID-related deaths, we recommend that countries join in the efforts of allocating COVID vaccines to countries in need. In addition, we recommend for the partial vaccination of a larger proportion of high-risk population as opposed to fully vaccinating half the amount. However, adequate supply of vaccines may be of limited use if not distributed in a time-sensitive manner. We recommend for the implementation of targeted and cost-effective vaccine allocation and distribution strategies in order to increase vaccination rates, reserve healthcare systems resources and avoid any preventable deaths associated with COVID-19 infections. As of July 20, 2021, a total of 191,943,037 confirmed cases of COVID-19 have been documented worldwide and 4,126,289 deaths and corresponds to a 2.1 % case-fatality ratio (CFR) [ 1 ]. As healthcare workers rose to the challenge to meet the demands of their communities, the great amount of exposure proved to be dire for those on the front lines. Some countries (e.g. Italy) put contingencies into place such as mandatory COVID-19 vaccination in healthcare workers in order to mitigate the risk posed to healthcare personnel, as the Moderna, Pfizer, and AstraZeneca vaccines were shown to have reasonable efficacy (Paterlini, 2021; Kakulavarapu et al., 2021) [ 2 , 3 ].

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India’s COVID-vaccine woes — by the numbers

Cited by 32 publications

References 0 publications

Immunogenicity, safety, and reactogenicity of heterologous COVID-19 primary vaccination incorporating mRNA, viral-vector, and protein-adjuvant vaccines in the UK (Com-COV2): a single-blind, randomised, phase 2, non-inferiority trial

Immunogenicity, safety, and reactogenicity of heterologous COVID-19 primary vaccination incorporating mRNA, viral-vector, and protein-adjuvant vaccines in the UK (Com-COV2): a single-blind, randomised, phase 2, non-inferiority trial

Vaccine Development against COVID-19: Study from Pre-Clinical Phases to Clinical Trials and Global Use

Disparities in global COVID-19 vaccination rates & allocation of resources to countries in need

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